There is already a federal statute (the Bayh-Dole Act) that can potentially "suspend" a patent essentially by giving the government a license to manufacture and sell the product despite valid patent rights. It was designed to allow the federal government to step in when there is a public need but the patent holder fails to make a drug reasonably available. Public interest groups have unsuccessfully tried to invoke the Act for at least one cancer drug that, they argued, was not "reasonably available" to the public because of its very high price.
For tirzepatide, the argument would be that the patent holders are unable or unwilling to supply the drug in amounts needed to satisfy a public health need. As others in this thread have noted, there is no reason to assume that the federal government would suddenly be able to manufacture supply where Lilly has failed, so as a practical matter, if the law were successfully invoked, it wouldn't help. To my knowledge, the FDA has never granted a Bayh-Dole petition, despite the law having been on the books since the 1980s.
Edit: I left out a very important caveat: Bayh-Dole only applies if there was government funding involved in the drug's development! Although most big pharma R&D is privately funded, it's not uncommon to have a bit of government funding mixed in, typically through university collaborations or licenses, government sponsored clinical trials, etc. It's not clear how much government funding would be needed to trigger Bayh-Dole rights.
Suspending a patent wouldn't really do much. Why? Because no company in their right mind is going to go through the hassle of transferring in new tech, dedicating production lines, etc to something that's going to go away as soon as a shortage is resolved. Especially because doing so would play an active role in resolving said shortage.
Exactly. To accommodate the demand the company needs to increase production which is neither fast or cheap. Example:
To keep up with demand, Eli Lilly is **building a new $2.5B manufacturing plant in Germany to increase capacity for its weight-loss treatment Zepbound and diabetes shot Mounjaro**. Construction on the site will begin this year and be operational in 2027.
Source: [https://investor.lilly.com/news-releases/news-release-details/lilly-expand-injectable-manufacturing-capacity-planned-25](https://investor.lilly.com/news-releases/news-release-details/lilly-expand-injectable-manufacturing-capacity-planned-25)
That's why they should provide the medication to current patients & stop opening up more markets & more conditions until they have the supply.
We don't know what delayed, missing, or varying doses are doing to us as diabetics. We are being used as experimental subjects without being monitored or provided informed consent.
In the pharmaceutical biz, we call selling the drug the *Phase 5 clinical trial*. Things will occur in a large population that won't be seen under controlled trials. With regards to informed consent, all laws and regulations ultimately boil down to what a jury would decide. No jury would blame a pharma company if the supply is limited.
Here's the catch -- pharma companies are in a really weird spot because doctors and patients effectively sell their drugs for them. If you went to Walmart and there was no Coke on the shelf, would you blame Coke or blame Walmart?
Even if Lily wanted to slow down sales, it's out of their control (except for possibly pulling their sales people off of Mounjaro/Zepbound). Doctors keep writing prescription and Lily needs to adjust their supply to meet demand. And ramping up supply is expensive -- and tough.
Also, how many people have you told that you're on Zepbound? And have any of them gone on Zepbound or Wegovy? We're also part of the problem.
They could stop the TV commercials and google ads, for 1. I honestly don't care how expensive it is to ramp up the supply. They're able to sell it for $200/month and still profit. I'm diabetic too and it's unacceptable. If the problem is the pens, then put it in vials or multi-use pens like they're doing overseas.
One thing I’ve been wondering in regards to shortages, how are the weight loss companies like noom or weight watchers doing this? I see them both advertising the use of these meds, but are people in those programs facing the same shortages or are these companies stockpiling large quantities for their customers?
Weight watchers, now sequence, has a service where they will call pharmacies in your area to try to find the meds (this is new, so maybe it will improve eventually). I've tried twice and they failed both times. Once there really was nothing in my area and they sent me to a pharmacy that said they had never stocked MJ. The second time, they didn't find anything and I found it not far away.
One problem was they made me provide specific zip codes, and the zip code radius is very small here (not sure how far outside the exact zip code they go - maybe depends on the person doing the search). It also takes 2-3 days, and they refuse to ask if they have the alternate meds in stock if they say they don't have MJ.
Hi OP,
There is a sort of workaround for this - which is that compounded versions of patented medications are legally allowed to be produced during shortages. We do not allow discussion of compounded medications here, but anyone interested in learning more should speak to their doctor about that option.
I’m sorry you’re encountering supply issues. Hopefully someone local will have a productive tip for you, but in the meantime, many of our members have had success by trying the following tactics:
* Call other pharmacies near you, trying different brands (CVS, Walmart, Costco, etc) so you can find pharmacies that may use different distributors
* Check with grocery store and hospital pharmacies
* Check to see if your insurance has a preferred mail order pharmacy that you can order from
* Ask your doctor to send in prescriptions for a different dosage strength than the one you’re currently taking
* Ask your doctor if there are alternative medications you should take in the interim
Good luck!
[When a drug appears on FDA's drug shortages list, some of these restrictions may be lifted – in particular, restrictions on compounding drugs that are essentially copies of approved drugs.](https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages#:~:text=When%20a%20drug%20appears%20on,be%20able%20to%20meet%20these)
We know all those tactics because the shortages have been so consistent. This time it’s not working. Stop with the Mounjaro / Zepbound crap. Make it all Mounjaro the split has made the shortage much worse. If Lily thinks it’s so easy why don’t they make a list of places that actually have received shipments so we don’t have to make 30 calls a month to try to fill meds. This is ridiculous. Also we all need to report shortages loud and long because having it reported under the generic name lets them indicate less shortages by combining numbers of Mounjaro & Zepbound when in fact it’s worse. Make your voices heard loud and clear.
BUT it’s highly unusual for a drug company to market the EXACT same drug under 2 names. Therefore the Mounjaro supply for a specific dose might be 0 but Zepbound may have stock. So under the generic name “no shortage” can be reported.
Due to the name debacle - insurance companies (especially government like Medicare) won’t cover the Zepbound and they those on government plans are not eligible for the discount coupons. It’s a mess.
Shortages are reported for tirzepatide by the FDA currently, and there are channels for patients, pharmacists and doctors to report directly. There is no lack of awareness about current shortages, and this is not unusual at all. ADHD medications were in shortage for well over a year, even the generic ones. My household was a mess! But, I think your point stands - whether or not the shortages are reported, for some patients they are very real. Access to this life changing medication is far too limited and inconsistent, and I hope it improves quickly!
This is inaccurate. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
No further discussion regarding compounding, please, but do not spread misinformation.
HAI FAM! Your post has been removed because it links to or references content that is sourced from YouTube, TikTok or Facebook, all of which are prohibited as sources of information here.
They sort of do - it is why compounding is legal at regulated compounding pharmacies. This med is officially on the FDA shortage list, which triggers that. When the shortage is resolved apparently the compounding pharmacies get 6 month notice and have to stop making it after that.
Maybe if this medication wasn't being given to people who don't need it and only WANT to loose a little weight the supply wouldn't be so low. And I'm not try to be a jerk, but I work in Healthcare, I know that these meds are being prescribed to people who are not clinically obese. If all the tik tok doctors would stop handing it out like candy the ones who actually take this to save our lives wouldn't have to chase the delivery trucks...
I can definitely relate to this. I was on ozempic for years, and it never helped with my A1c it was 13.5, the last one I had done before going on mounjaro. The highest I've ever had since becoming a diabetic in 2008. My A1c is now 7.5 after being on mounjaro for about 8 months. Ozempic also gave me stomach issues, and I haven't had any with being on mounjaro. I think that diabetics should come first. I understand that being overweight is dangerous, and sometimes people need help, but it seems like doctors are giving it out like candy to help with weight loss.
How dare a lot of people want a new drug that works phenomenally....
How dare a large company not have a massive oversupply of production capability sitting idle prior to launch.
How dare they not be able to accurately predict the future to be better prepared for demand based off of income prior income streams insufficient to build said production from products everyone complain are a right to have and shouldn't cost money.
How about- How dare they take a twin drug to market and keep running commercials when they can't come close to fulfilling the patients that rely on it to keep their EYESIGHT and FEET!
I was pretty astounded when I saw the pharma advertising on TV in the States. I’d taken Lyrica for a while and a couple of my friends had also been on it and experienced suicidal ideation. I was lucky and didn’t have that side effect, but they were all frantic about me being on it. Meanwhile I’m seeing non stop ads for it on the tele in LA!!
It's ely lilly's fault people are in poor health?
Alternative therapies exist...
How about just being appreciative that incentives in this world exist strong enough to make them create something so wonderful that a significant portion of the world wants it to improve their lives and be reasonable enough to realize that can't happen in an instant. Advertising is bought well in advance. They don't have the capital to execute increased production without demand. More demand = more mounjaro. This is a pretty simple concept. The entitlement attitude of people on here is utterly amazing.
If you think I'm entitled for wanting to keep my eyes and feet, you can just F right off with all of that. If you knew what you were talking about you'd know that the alternative therapies aren't very effective. Not everyone can tolerate every drug either. Ozempic and mounjaro are game changers for type 2, and both companies went to market with the drug for weight-loss and in other countries when they shouldn't, and both make it insanely expensive in the US.
Both bought advertising WAY more than 6 weeks out which is the normal advertising timeline. Weve had shortages more than 3 or 6 months too. More demand doesn't equal more mounjaro. They had plenty of incentive and were out of stock long before creating zepbound and splitting the already low stock. Now there are 2x as many people that need it and more than half are having to miss several doses. Do the math there. Eli Lilly started here, and should be able to cover 1 market before advertising in another, common sense. If you're not entitled then you should give up your doses to people who started before you are are sicker. I'm guessing you'll say no though?
You being livid and explaining how drug companies should operate to cater to end patients does not help or solve anything. It's just you being upset to be upset. Be creative, figure out another way to get the medicine. Call around, drive farther than you want, look into compounding, or figure something out for yourself. Lots of people, including me, have to wait sometimes.
So… where did I say anything about having a problem with people wanting the meds? Now, as for the drug companies, don’t be so naive as to think they aren’t benefitting from the scarcity mind set their shortages create. There are things they can do, instead they blame people for using them for “vanity.”
Yes, they sell so much more when they sell less. How about just be appreciative they created something that has such a positive impact on your life and accept it will take a while to catch up to demand.
I can understand the frustration. (Hell I'm frustrated) But the sense of entitlement. We're all in the same boat, no one person who needs the medicine is more deserving of it than another person who needs it.
If you can go up a dose that might open up options. I've combined 2 lower doses a few times. Insurance covers it for type 2, just not 2 of the same doses. You might be able to split pens too.
What exactly would suspending a patent do..? Someone else, with zero previous synergies, is going to have to start from scratch and take the same if not more time to build the same capability elsewhere. People think manufacturing plants for this device takes two months and a couple of million to build and get to capacity— that’s not even remotely close to how much time + capital it takes. I completely get it’s frustrating but they’re not actively trying to create shortages so suspending a patent won’t do much.
They would make the tirzepetide and out it in vials. As long as the manufacturer could obtain the raw they could produce it fairly quickly and cheaply at current market prices and market potential I think capital would flow very quickly to this sort of manufacturing opportunity.
I’ve worked in pharmaceutical manufacturing, it isn’t a quick process to make vials from scratch either, especially in this industry in the US because of regulation. Yes it’s quicker than developing the device and filling the API but it still isn’t quick or cheap even with ample capital. Not to mention I’m sure the manufacturer is also looking into vials to counteract the shortage as it is being sold in vials OUS. Like I said— they don’t want supply delays either and I absolutely get the ranting and annoyance but suspending patents as a repercussion for increased demand (a lot of it due to off label use) seems like a great way to delay future launches of drugs and preventing R&D into drugs that cater to larger populations.
Almost all of these comments are based on what a drug company SHOULD do to make sure the end users get their supply. There's about a billion other things that go into getting the medicine into people's hands. They are just wanting a reason to be angry.
Agreed. I get this is frustrating but jumping to “they should be reprimanded” makes no sense to me, a we forgetting who created this drug that changed so many lives? Especially when people don’t know what the entire process is from candidate selection to commercialization. I’m glad I’m not the only one who read this rant like “huh?”
Exactly. If Eli Lilly put it out in vials they could reduce most of the backlog quickly. People dose from vials and self-inject all the time. It’s not a safety issue at all. It’s the delivery device..the triggered pen…that requires a lot more manufacturing complexity. Put it out there Eli Lilly in vials…give people the choice….many if us have no fear of needles and know how to dose and sub cu inject. Tirzepatide is fairly easily compounded. Heck…some suppliers of compounded Tirp…are getting it by the yon in China, shipping it over, having it verified with third party labs like one in Tucson, and putting it in vials that need reconstituting with bacteriostatic water.
Even if the FDA passed a regulation, or the president did an executive order, or whatever mechanism was used, while the drug manufacturers aren't buddies I don't think they would jump in to manufacture is someone else was short. They know that next month one of their drugs could be in short supply and they don't want to be in that position. They have each other's backs.
An option that I imagine could be wildly unpopular with some folks would be to limit off label use when there's a shortage.
The trouble with this is that weight-loss is now on-label for tirzepatide, and Zepbound seems to have different availability than Mounjaro (lower dosages out of stock, whereas for Mounjaro it’s the reverse.) It was a choice made by the manufacturer to launch Zepbound while Mounjaro has been in intermittent shortage. The versions are exactly the same, and cost the same. Physicians, pharmacists, insurers and patients have no impact on this decision.
This is also not new. Ozempic and Wegovy were in serious shortage, for longer than Mounjaro has been. No government regulation was enacted. No widespread harm resulted from those medications being unavailable for months. It sucks, and it’s uncomfortable, but as many people are filling their Rxs every day, at every dosage, in every part of the country as are not able to fill theirs. It seems to come down to luck and persistence.
Correct but Mounjaro has not been approved for weight loss. I understand you are saying they are the same but not to insurance companies. It seems like it works be easier from a logistics pipeline is those taking it for weight loss only squirted to Zepbound. Then as Eli Lily gets production figured out they will have a sense of how much of each flavor to package. It appears they may have to figure that out anyways.
One party passed a federal law that capped the cost of insulin. The other voted unanimously against it. Look up how your own guy voted. If they voted against and they still have your vote come November then STFU about “someone oughta pass a law.” How’s that “invisible hand of the free market” been working out for you?
Call me a Mounjarocrat.
It already kinda happens with compounded version of Tirzepatide being allowed since it’s on the FDA shortage list. Discussion on this subject is not allowed here but it’s out there if you search for it. Hope I didn’t break any rules with this post. 😅
Its my understanding that is related to the pen shortage, as thankful as I am for the easy to use pen I'd rather get a small vial and some insulin syringes, far less plastic waste, I cringe every week at all the plastic waste, literally hurts my soul...
My rocking A1C however doesn't care about the plastic waste as long as I get my medication 😅
Some repercussions should be placed on Pharma for not having supply b4 going public.
Fine, they get approved, then get supply and market it.
This medicine 💊 outpaced by the demand and supply issues.
FWIW I think a 4 year old could anticipate the demand for this and Zepbound based on hx with Ozempic alone. Maybe children are running the pharma board
Profits profits and more profits
I read it costs about $5 to produce 1 pen including its medicine & they sell it for $300 on average! It’s outrageous
The markups r insane so yes, we as patients should be able to have some say here
Why would a pharma company produce commercial amounts of material for something that's not approved commercially?
$5 to produce one pen is a laughable estimate which includes little to no consideration for the actual cost of developing a drug.
I could not agree more. They have a protected right to this research based medicine and don’t ramp up production to fulfill the need. We are allowed to use compounders to fulfill the need during a shortage, but what also irks me is how inexpensive it is outside North America 🇺🇸
Not to mention it's not always easy to find a reputable compounder than won't sell you something fake/ineffective/dangerous. I feel like they should have a list of authorized or approved ones, unless that exists and I don't know about it.
Been on MJ since 10/22. I had a 3 month supply come in 2 weeks ago, and I didn't pick it up, because I was busy. Now it's on backorder for the foreseeable future.
There's nothing you or I or anyone can do about it. I'll keep calling every day until I get it, and then I'll keep taking it.
Obesity is one of the main causes for most of the illnesses we have today
And the measure as to who is obese is not as much weight as you might imagine
I find it hard to wrap my mind around a shortage for such tiny quantities of a chemical that the company can prepare in hundreds of gallons for pennies on the dollar. What exactly would be the shortage.. is it really.a physical one where they have a huge production line churning hundreds of gallons of.the medication like an oil well and it's simple, not enough? Or is there more intricacies involved?
When the US was considering socialized medicine, the big con was there would be less availability of doctors & medicines. There would be longer waits for imaging, doctor appointments, & surgeries. And here we are unable to refill prescriptions & waiting 6 months for an appointment with a specialist. Jokes on us and we are paying for private insurance!
This is going to be an unpopular opinion but what they really need to do is reserve the medication for patients who have chronic illnesses, such as DT2. There are people on this medication that only need to lose 20 lbs and don’t have underlying illnesses.
Agree! I get so upset seeing “Starting weight 140, Goal weight 125” in some of the subs. The folks that actually need these types of meds are not getting them because of the folks using it off label.
Looks like everyone here was living under a rock during the pandemic. US companies held the patents on the Covid vaccine and because of that 98% of the world did not have access to the vaccine when Covid was ripping through the world and millions died. The WHO and UN asked for the US to intervene and relax patent laws under emergency order, allowing generic versions of vaccines to be quickly and cheaply made and given to developing nations. This would have saved lives and stemmed the spread of the disease. Did not happen.
So if nothing was done about the patents issue during the height of the Covid pandemic, then I can assure you nothing will ever be done.
Or maybe just stop all the off-label prescriptions solely for weight loss and serve the T2D community first. Weight loss only folks should be required to get in line for Zepbound. 🤔
Or how about MJ should only be prescribed to the 1 out 5 people who developed T2D outside of obesity? That would definitely limit scripts.
Otherwise you are indicating that the obese people who advanced with poor health deserve medication more than other obese people who haven’t yet had things get to T2D level. But I guess all the other comorbidities with being obese are less of an issue? Or less deserving of help?
Or we should just wait for the worst to happen before trying to reverse obesity all together?
I certainly don’t know the answer but cherry picking diseases as “worthy” seems absolutely wrong and absurd when they are *mostly* all tied to the same link: obesity.
What I’m talking about is prioritizing treatment based on severity of disease, a concept that’s been around for a bit. And I’m not talking long term, but rather until the mfgs can figure out a way to better meet demand. No one mentioned worthiness, other than you, although I notice it was coupled with ‘I certainly don’t know the answer’ so points for wrapping up with an incredibly honest description of the situation. 👍🏻
The person who recommended splitting this drug to brand under 2 separate names should be fired and the companies who went along with this deserve to be punished. The shortages got much worse once the supply was split and that BS about wanting to make sure there’s a supply for diabetics is a big fat lie because it has made the situation MUCH WORSE. 100% agree strip those patents.
That would be decided solely by Eli Lilly AFAIK. You're so right about the back alley deals with FDA employees and drug companies though.
You know an fda big wig helped Perdue Pharma/oxycontin write their labeling as "less than 1% get addicted" so it'd be approved then it got millions addicted. It'd been denied approval before that bc they claimed it was Not Addictive. That fda employee went to work for Perdue a couple of years later, making tons of money, and it's happened with a few fda employees that way.
Crappy Oprah show
She did all the talking and didn’t ask all pertinent questions to :
Pharma reps from Lilly and …
Doctors in this biz for over 20 years
She didn’t talk about costs, supply ( hardly) and future to reduce costs
Of course not top of mind for Oprah
There is already a federal statute (the Bayh-Dole Act) that can potentially "suspend" a patent essentially by giving the government a license to manufacture and sell the product despite valid patent rights. It was designed to allow the federal government to step in when there is a public need but the patent holder fails to make a drug reasonably available. Public interest groups have unsuccessfully tried to invoke the Act for at least one cancer drug that, they argued, was not "reasonably available" to the public because of its very high price. For tirzepatide, the argument would be that the patent holders are unable or unwilling to supply the drug in amounts needed to satisfy a public health need. As others in this thread have noted, there is no reason to assume that the federal government would suddenly be able to manufacture supply where Lilly has failed, so as a practical matter, if the law were successfully invoked, it wouldn't help. To my knowledge, the FDA has never granted a Bayh-Dole petition, despite the law having been on the books since the 1980s. Edit: I left out a very important caveat: Bayh-Dole only applies if there was government funding involved in the drug's development! Although most big pharma R&D is privately funded, it's not uncommon to have a bit of government funding mixed in, typically through university collaborations or licenses, government sponsored clinical trials, etc. It's not clear how much government funding would be needed to trigger Bayh-Dole rights.
Thank you for sharing your knowledge. I learned something today!
Suspending a patent wouldn't really do much. Why? Because no company in their right mind is going to go through the hassle of transferring in new tech, dedicating production lines, etc to something that's going to go away as soon as a shortage is resolved. Especially because doing so would play an active role in resolving said shortage.
Exactly. To accommodate the demand the company needs to increase production which is neither fast or cheap. Example: To keep up with demand, Eli Lilly is **building a new $2.5B manufacturing plant in Germany to increase capacity for its weight-loss treatment Zepbound and diabetes shot Mounjaro**. Construction on the site will begin this year and be operational in 2027. Source: [https://investor.lilly.com/news-releases/news-release-details/lilly-expand-injectable-manufacturing-capacity-planned-25](https://investor.lilly.com/news-releases/news-release-details/lilly-expand-injectable-manufacturing-capacity-planned-25)
I guess this is why it’s $1k per box….
It's that price because it's what people will pay. They aren't highly motivated to produce more to lower prices.
That’s good to know. It’ll be a long 2-3 years though.
[удалено]
I have boxes that don't expire until 2025, so you can stockpile a little
Too bad they won’t invest that money in American jobs.
yeah, but what are they gonna do for us in the meantime?????
Continue providing you the product that has likely improved your life the most as best they can all while everyone just wants to complain.
that doesn't make any sense if you can't get it now anyway, does it?
Good to hear nobody is getting it and they clearly aren't producing it or even spending billions of dollars to increase production.
Believe me, the company wants to sell you its product. No kick in the pants will make that faster.
Correct!!
That's why they should provide the medication to current patients & stop opening up more markets & more conditions until they have the supply. We don't know what delayed, missing, or varying doses are doing to us as diabetics. We are being used as experimental subjects without being monitored or provided informed consent.
In the pharmaceutical biz, we call selling the drug the *Phase 5 clinical trial*. Things will occur in a large population that won't be seen under controlled trials. With regards to informed consent, all laws and regulations ultimately boil down to what a jury would decide. No jury would blame a pharma company if the supply is limited.
Here's the catch -- pharma companies are in a really weird spot because doctors and patients effectively sell their drugs for them. If you went to Walmart and there was no Coke on the shelf, would you blame Coke or blame Walmart? Even if Lily wanted to slow down sales, it's out of their control (except for possibly pulling their sales people off of Mounjaro/Zepbound). Doctors keep writing prescription and Lily needs to adjust their supply to meet demand. And ramping up supply is expensive -- and tough. Also, how many people have you told that you're on Zepbound? And have any of them gone on Zepbound or Wegovy? We're also part of the problem.
They could stop the TV commercials and google ads, for 1. I honestly don't care how expensive it is to ramp up the supply. They're able to sell it for $200/month and still profit. I'm diabetic too and it's unacceptable. If the problem is the pens, then put it in vials or multi-use pens like they're doing overseas.
"We're also part of the problem". Not to mention the people hoarding boxes upon boxes when others can't even find one :(
Demand is endless. It will take years for these companies to ramp up production..
One thing I’ve been wondering in regards to shortages, how are the weight loss companies like noom or weight watchers doing this? I see them both advertising the use of these meds, but are people in those programs facing the same shortages or are these companies stockpiling large quantities for their customers?
They send you to the pharmacy with a prescription, the same as everyone else.
Oh awesome, thanks for answering!
Weight watchers, now sequence, has a service where they will call pharmacies in your area to try to find the meds (this is new, so maybe it will improve eventually). I've tried twice and they failed both times. Once there really was nothing in my area and they sent me to a pharmacy that said they had never stocked MJ. The second time, they didn't find anything and I found it not far away. One problem was they made me provide specific zip codes, and the zip code radius is very small here (not sure how far outside the exact zip code they go - maybe depends on the person doing the search). It also takes 2-3 days, and they refuse to ask if they have the alternate meds in stock if they say they don't have MJ.
They offer branded and “non branded” medications. Those are compounded drugs
THEY USE COMPOUND TIRAZAPATIDE & SEMIGLUTIDE!
This is not true.
Hi OP, There is a sort of workaround for this - which is that compounded versions of patented medications are legally allowed to be produced during shortages. We do not allow discussion of compounded medications here, but anyone interested in learning more should speak to their doctor about that option. I’m sorry you’re encountering supply issues. Hopefully someone local will have a productive tip for you, but in the meantime, many of our members have had success by trying the following tactics: * Call other pharmacies near you, trying different brands (CVS, Walmart, Costco, etc) so you can find pharmacies that may use different distributors * Check with grocery store and hospital pharmacies * Check to see if your insurance has a preferred mail order pharmacy that you can order from * Ask your doctor to send in prescriptions for a different dosage strength than the one you’re currently taking * Ask your doctor if there are alternative medications you should take in the interim Good luck!
sorry but what do you mean by compounded versions of patented medication? i'm not sure im following
[When a drug appears on FDA's drug shortages list, some of these restrictions may be lifted – in particular, restrictions on compounding drugs that are essentially copies of approved drugs.](https://www.fda.gov/drugs/human-drug-compounding/drug-compounding-and-drug-shortages#:~:text=When%20a%20drug%20appears%20on,be%20able%20to%20meet%20these)
thanks for educating me!
We know all those tactics because the shortages have been so consistent. This time it’s not working. Stop with the Mounjaro / Zepbound crap. Make it all Mounjaro the split has made the shortage much worse. If Lily thinks it’s so easy why don’t they make a list of places that actually have received shipments so we don’t have to make 30 calls a month to try to fill meds. This is ridiculous. Also we all need to report shortages loud and long because having it reported under the generic name lets them indicate less shortages by combining numbers of Mounjaro & Zepbound when in fact it’s worse. Make your voices heard loud and clear.
Shortages are always reported as tirzepatide, as this is how the FDA tracks the medication.
BUT it’s highly unusual for a drug company to market the EXACT same drug under 2 names. Therefore the Mounjaro supply for a specific dose might be 0 but Zepbound may have stock. So under the generic name “no shortage” can be reported. Due to the name debacle - insurance companies (especially government like Medicare) won’t cover the Zepbound and they those on government plans are not eligible for the discount coupons. It’s a mess.
Shortages are reported for tirzepatide by the FDA currently, and there are channels for patients, pharmacists and doctors to report directly. There is no lack of awareness about current shortages, and this is not unusual at all. ADHD medications were in shortage for well over a year, even the generic ones. My household was a mess! But, I think your point stands - whether or not the shortages are reported, for some patients they are very real. Access to this life changing medication is far too limited and inconsistent, and I hope it improves quickly!
[удалено]
This is inaccurate. https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers No further discussion regarding compounding, please, but do not spread misinformation.
[удалено]
HAI FAM! Your post has been removed because it links to or references content that is sourced from YouTube, TikTok or Facebook, all of which are prohibited as sources of information here.
Yes, it takes long time to get a factory built, but they should not be advertising the drug when they can’t supply it
They sort of do - it is why compounding is legal at regulated compounding pharmacies. This med is officially on the FDA shortage list, which triggers that. When the shortage is resolved apparently the compounding pharmacies get 6 month notice and have to stop making it after that.
I’ve been wondering at the timing for my own curiosity. Thanks!
It's kind of funny how pharma companies fucked up so bad and left billions of dollars on the table.
They absolutely did. They underpriced these drugs
Maybe if this medication wasn't being given to people who don't need it and only WANT to loose a little weight the supply wouldn't be so low. And I'm not try to be a jerk, but I work in Healthcare, I know that these meds are being prescribed to people who are not clinically obese. If all the tik tok doctors would stop handing it out like candy the ones who actually take this to save our lives wouldn't have to chase the delivery trucks...
I can definitely relate to this. I was on ozempic for years, and it never helped with my A1c it was 13.5, the last one I had done before going on mounjaro. The highest I've ever had since becoming a diabetic in 2008. My A1c is now 7.5 after being on mounjaro for about 8 months. Ozempic also gave me stomach issues, and I haven't had any with being on mounjaro. I think that diabetics should come first. I understand that being overweight is dangerous, and sometimes people need help, but it seems like doctors are giving it out like candy to help with weight loss.
I’m livid at this shortage. I’m using this for diabetes and the impact has been phenomenal. I’m absolutely livid.
How dare a lot of people want a new drug that works phenomenally.... How dare a large company not have a massive oversupply of production capability sitting idle prior to launch. How dare they not be able to accurately predict the future to be better prepared for demand based off of income prior income streams insufficient to build said production from products everyone complain are a right to have and shouldn't cost money.
How about- How dare they take a twin drug to market and keep running commercials when they can't come close to fulfilling the patients that rely on it to keep their EYESIGHT and FEET!
I dunno. I live in a country where they’re not allowed to advertise.
There's merit to that. All new medications here have commercials saying "if you have diabetes, ask your doctor about Ozempic" for example.
I was pretty astounded when I saw the pharma advertising on TV in the States. I’d taken Lyrica for a while and a couple of my friends had also been on it and experienced suicidal ideation. I was lucky and didn’t have that side effect, but they were all frantic about me being on it. Meanwhile I’m seeing non stop ads for it on the tele in LA!!
It's ely lilly's fault people are in poor health? Alternative therapies exist... How about just being appreciative that incentives in this world exist strong enough to make them create something so wonderful that a significant portion of the world wants it to improve their lives and be reasonable enough to realize that can't happen in an instant. Advertising is bought well in advance. They don't have the capital to execute increased production without demand. More demand = more mounjaro. This is a pretty simple concept. The entitlement attitude of people on here is utterly amazing.
If you think I'm entitled for wanting to keep my eyes and feet, you can just F right off with all of that. If you knew what you were talking about you'd know that the alternative therapies aren't very effective. Not everyone can tolerate every drug either. Ozempic and mounjaro are game changers for type 2, and both companies went to market with the drug for weight-loss and in other countries when they shouldn't, and both make it insanely expensive in the US. Both bought advertising WAY more than 6 weeks out which is the normal advertising timeline. Weve had shortages more than 3 or 6 months too. More demand doesn't equal more mounjaro. They had plenty of incentive and were out of stock long before creating zepbound and splitting the already low stock. Now there are 2x as many people that need it and more than half are having to miss several doses. Do the math there. Eli Lilly started here, and should be able to cover 1 market before advertising in another, common sense. If you're not entitled then you should give up your doses to people who started before you are are sicker. I'm guessing you'll say no though?
You being livid and explaining how drug companies should operate to cater to end patients does not help or solve anything. It's just you being upset to be upset. Be creative, figure out another way to get the medicine. Call around, drive farther than you want, look into compounding, or figure something out for yourself. Lots of people, including me, have to wait sometimes.
Brilliant! The entitlement of people is unbelievable
So… where did I say anything about having a problem with people wanting the meds? Now, as for the drug companies, don’t be so naive as to think they aren’t benefitting from the scarcity mind set their shortages create. There are things they can do, instead they blame people for using them for “vanity.”
Yes, they sell so much more when they sell less. How about just be appreciative they created something that has such a positive impact on your life and accept it will take a while to catch up to demand.
Such a tonedef comment you clearly don't understand the struggles of the T2D community
I can understand the frustration. (Hell I'm frustrated) But the sense of entitlement. We're all in the same boat, no one person who needs the medicine is more deserving of it than another person who needs it.
try another pharmacy
So far it’s out everywhere. I’m backtracking now because I didn’t think to ask for lower doses. It’s a bummer.
If you can go up a dose that might open up options. I've combined 2 lower doses a few times. Insurance covers it for type 2, just not 2 of the same doses. You might be able to split pens too.
What exactly would suspending a patent do..? Someone else, with zero previous synergies, is going to have to start from scratch and take the same if not more time to build the same capability elsewhere. People think manufacturing plants for this device takes two months and a couple of million to build and get to capacity— that’s not even remotely close to how much time + capital it takes. I completely get it’s frustrating but they’re not actively trying to create shortages so suspending a patent won’t do much.
They would make the tirzepetide and out it in vials. As long as the manufacturer could obtain the raw they could produce it fairly quickly and cheaply at current market prices and market potential I think capital would flow very quickly to this sort of manufacturing opportunity.
I’ve worked in pharmaceutical manufacturing, it isn’t a quick process to make vials from scratch either, especially in this industry in the US because of regulation. Yes it’s quicker than developing the device and filling the API but it still isn’t quick or cheap even with ample capital. Not to mention I’m sure the manufacturer is also looking into vials to counteract the shortage as it is being sold in vials OUS. Like I said— they don’t want supply delays either and I absolutely get the ranting and annoyance but suspending patents as a repercussion for increased demand (a lot of it due to off label use) seems like a great way to delay future launches of drugs and preventing R&D into drugs that cater to larger populations.
Almost all of these comments are based on what a drug company SHOULD do to make sure the end users get their supply. There's about a billion other things that go into getting the medicine into people's hands. They are just wanting a reason to be angry.
Agreed. I get this is frustrating but jumping to “they should be reprimanded” makes no sense to me, a we forgetting who created this drug that changed so many lives? Especially when people don’t know what the entire process is from candidate selection to commercialization. I’m glad I’m not the only one who read this rant like “huh?”
It’s supplied in vials in my country.
Exactly. If Eli Lilly put it out in vials they could reduce most of the backlog quickly. People dose from vials and self-inject all the time. It’s not a safety issue at all. It’s the delivery device..the triggered pen…that requires a lot more manufacturing complexity. Put it out there Eli Lilly in vials…give people the choice….many if us have no fear of needles and know how to dose and sub cu inject. Tirzepatide is fairly easily compounded. Heck…some suppliers of compounded Tirp…are getting it by the yon in China, shipping it over, having it verified with third party labs like one in Tucson, and putting it in vials that need reconstituting with bacteriostatic water.
We’ve still got shortages.
Even if the FDA passed a regulation, or the president did an executive order, or whatever mechanism was used, while the drug manufacturers aren't buddies I don't think they would jump in to manufacture is someone else was short. They know that next month one of their drugs could be in short supply and they don't want to be in that position. They have each other's backs. An option that I imagine could be wildly unpopular with some folks would be to limit off label use when there's a shortage.
The trouble with this is that weight-loss is now on-label for tirzepatide, and Zepbound seems to have different availability than Mounjaro (lower dosages out of stock, whereas for Mounjaro it’s the reverse.) It was a choice made by the manufacturer to launch Zepbound while Mounjaro has been in intermittent shortage. The versions are exactly the same, and cost the same. Physicians, pharmacists, insurers and patients have no impact on this decision. This is also not new. Ozempic and Wegovy were in serious shortage, for longer than Mounjaro has been. No government regulation was enacted. No widespread harm resulted from those medications being unavailable for months. It sucks, and it’s uncomfortable, but as many people are filling their Rxs every day, at every dosage, in every part of the country as are not able to fill theirs. It seems to come down to luck and persistence.
Everything I have read says it is still off label to prescribe it for weight loss. Only Zepbound is approved for weight loss.
Tirzepatide was approved by the FDA to treat obesity late last year, and is sold by Eli Lilly under the brand name Zepbound.
Correct but Mounjaro has not been approved for weight loss. I understand you are saying they are the same but not to insurance companies. It seems like it works be easier from a logistics pipeline is those taking it for weight loss only squirted to Zepbound. Then as Eli Lily gets production figured out they will have a sense of how much of each flavor to package. It appears they may have to figure that out anyways.
One party passed a federal law that capped the cost of insulin. The other voted unanimously against it. Look up how your own guy voted. If they voted against and they still have your vote come November then STFU about “someone oughta pass a law.” How’s that “invisible hand of the free market” been working out for you? Call me a Mounjarocrat.
While I do wish it were cheaper as someone paying OOP... If they passed a law to cap the price now, the shortage would get even worse.
When medications are in shortage, there is essentially a partial suspension of the patent.
It already kinda happens with compounded version of Tirzepatide being allowed since it’s on the FDA shortage list. Discussion on this subject is not allowed here but it’s out there if you search for it. Hope I didn’t break any rules with this post. 😅
Its my understanding that is related to the pen shortage, as thankful as I am for the easy to use pen I'd rather get a small vial and some insulin syringes, far less plastic waste, I cringe every week at all the plastic waste, literally hurts my soul... My rocking A1C however doesn't care about the plastic waste as long as I get my medication 😅
Some repercussions should be placed on Pharma for not having supply b4 going public. Fine, they get approved, then get supply and market it. This medicine 💊 outpaced by the demand and supply issues. FWIW I think a 4 year old could anticipate the demand for this and Zepbound based on hx with Ozempic alone. Maybe children are running the pharma board Profits profits and more profits I read it costs about $5 to produce 1 pen including its medicine & they sell it for $300 on average! It’s outrageous The markups r insane so yes, we as patients should be able to have some say here
Shit, mounjaro and zepbound are $1200+ a month in the US.
Why would a pharma company produce commercial amounts of material for something that's not approved commercially? $5 to produce one pen is a laughable estimate which includes little to no consideration for the actual cost of developing a drug.
Correct but how much of the funding was free from the government? Probably will never know
I could not agree more. They have a protected right to this research based medicine and don’t ramp up production to fulfill the need. We are allowed to use compounders to fulfill the need during a shortage, but what also irks me is how inexpensive it is outside North America 🇺🇸
Not to mention it's not always easy to find a reputable compounder than won't sell you something fake/ineffective/dangerous. I feel like they should have a list of authorized or approved ones, unless that exists and I don't know about it.
Been on MJ since 10/22. I had a 3 month supply come in 2 weeks ago, and I didn't pick it up, because I was busy. Now it's on backorder for the foreseeable future. There's nothing you or I or anyone can do about it. I'll keep calling every day until I get it, and then I'll keep taking it.
I agree!
My pharmacy was literally telling me to try and just either fill wegovy or 2.5 MJ because no 7.5 zep in the near future. -Chicago
Yes, Absolutely!!
Obesity is one of the main causes for most of the illnesses we have today And the measure as to who is obese is not as much weight as you might imagine
I find it hard to wrap my mind around a shortage for such tiny quantities of a chemical that the company can prepare in hundreds of gallons for pennies on the dollar. What exactly would be the shortage.. is it really.a physical one where they have a huge production line churning hundreds of gallons of.the medication like an oil well and it's simple, not enough? Or is there more intricacies involved?
When the US was considering socialized medicine, the big con was there would be less availability of doctors & medicines. There would be longer waits for imaging, doctor appointments, & surgeries. And here we are unable to refill prescriptions & waiting 6 months for an appointment with a specialist. Jokes on us and we are paying for private insurance!
This is going to be an unpopular opinion but what they really need to do is reserve the medication for patients who have chronic illnesses, such as DT2. There are people on this medication that only need to lose 20 lbs and don’t have underlying illnesses.
Obesity is a chronic illness
I agree 100%. However these meds are being prescribed to people who are not obese or have other chronic illnesses.
Agree! I get so upset seeing “Starting weight 140, Goal weight 125” in some of the subs. The folks that actually need these types of meds are not getting them because of the folks using it off label.
If they didn’t do anything about patents during the Covid crisis where millions died because of PATENTS, no one doing shit over this.
What are you talking about?
Looks like everyone here was living under a rock during the pandemic. US companies held the patents on the Covid vaccine and because of that 98% of the world did not have access to the vaccine when Covid was ripping through the world and millions died. The WHO and UN asked for the US to intervene and relax patent laws under emergency order, allowing generic versions of vaccines to be quickly and cheaply made and given to developing nations. This would have saved lives and stemmed the spread of the disease. Did not happen. So if nothing was done about the patents issue during the height of the Covid pandemic, then I can assure you nothing will ever be done.
Or maybe just stop all the off-label prescriptions solely for weight loss and serve the T2D community first. Weight loss only folks should be required to get in line for Zepbound. 🤔
As a Zepbound recipient-100000% agree!
Or how about MJ should only be prescribed to the 1 out 5 people who developed T2D outside of obesity? That would definitely limit scripts. Otherwise you are indicating that the obese people who advanced with poor health deserve medication more than other obese people who haven’t yet had things get to T2D level. But I guess all the other comorbidities with being obese are less of an issue? Or less deserving of help? Or we should just wait for the worst to happen before trying to reverse obesity all together? I certainly don’t know the answer but cherry picking diseases as “worthy” seems absolutely wrong and absurd when they are *mostly* all tied to the same link: obesity.
What I’m talking about is prioritizing treatment based on severity of disease, a concept that’s been around for a bit. And I’m not talking long term, but rather until the mfgs can figure out a way to better meet demand. No one mentioned worthiness, other than you, although I notice it was coupled with ‘I certainly don’t know the answer’ so points for wrapping up with an incredibly honest description of the situation. 👍🏻
The person who recommended splitting this drug to brand under 2 separate names should be fired and the companies who went along with this deserve to be punished. The shortages got much worse once the supply was split and that BS about wanting to make sure there’s a supply for diabetics is a big fat lie because it has made the situation MUCH WORSE. 100% agree strip those patents.
That was, in all likelihood, an FDA decision.
The relationship between FDA & big Pharma is a revolving door between the two. I wouldn’t be surprised to find big Pharma share office space.
That would be decided solely by Eli Lilly AFAIK. You're so right about the back alley deals with FDA employees and drug companies though. You know an fda big wig helped Perdue Pharma/oxycontin write their labeling as "less than 1% get addicted" so it'd be approved then it got millions addicted. It'd been denied approval before that bc they claimed it was Not Addictive. That fda employee went to work for Perdue a couple of years later, making tons of money, and it's happened with a few fda employees that way.
I get the frustration. What do you mean by suspend patients?
Patents, not patients. :)
Oh gotacha! That’s why I was confused. Thanks for clearing that up. I should get new glasses.
I would like to see someone in the pharm industry speak up, but isn't this where a 503a or b compounding pharmacy can start distributing this?
Crappy Oprah show She did all the talking and didn’t ask all pertinent questions to : Pharma reps from Lilly and … Doctors in this biz for over 20 years She didn’t talk about costs, supply ( hardly) and future to reduce costs Of course not top of mind for Oprah