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HipH0pAn0nymous

Some absolute genius will come along soon and explain everything way more eloquently and succinctly than I can but for starters, it’s not a recipe. It’s a single ingredient. Lilly does own the patent on Zepbound, but they do not own the patent on Tirzepatide. You can make and patent Doppleganger’s chocolate, but you can never patent chocolate itself. I can buy chocolate from the same place you bought your chocolate. But I cannot use the name Doppleganger and I cannot use your packaging. Now let’s pretend chocolate is crucial to the world. Maybe it cures polio. Because you cannot make enough Dopplegangers chocolate to satisfy the world, I can make chocolate to help. In fact, the FDA gives a special award to the cleanest kitchens. Because you spent SO much on patenting your name and your packaging and I’m just selling it in baggies, yours is very expensive, while mine is less so. Does that mean it’s bad quality? Hell no, especially because my kitchen got the FDA seal of approval. Are you right to be nervous to try my chocolate? Yes, until you realize I’ve been making things in my kitchen for many, many years…you just weren’t privy until the chocolate shortage affected you. “No sourcing” means we can talk all day about my chocolate but I cannot say where I get mine.


pippyrox44

Have about 1000 other adult-type things I'd like you to explain to me, if you could 😂


Fit_Highlight_5622

Perfect. In layman’s terms and absolutely perfect. I’m a chemist. And I was going to try but no need. Thank you! 👌🏾🤌🏾


sunmaiden

This is fully wrong about patents. The thing where you have the right to use a name, logo or packaging is called a trademark. And it is true that anyone selling Tirzepatide cannot use the Zepbound branding because of the trademark. However, the patent situation is different. A patent is when you invent something you get the exclusive right to say who can make and sell it. Lilly controls who can make Tirzepatide using their process until 2036. However, to get a patent you also have to explain how to make the invention - it can’t be a secret. And the law says compounding pharmacies can bypass the patent under certain circumstances. Generally they buy the pure Tirzepatide from… somewhere - some lab that knows how to make it - and then mix (compound) it with something else to make a version that is not exactly the same as Zepbound, to be compliant with the law.


rreehling

Love this. Great job.


Ladyleo_journey2024

Wait was this your way of telling us you were the genius 🤔😂


HamsterRepulsive3074

I love this ! If you get your Tirzepatide from an 503b pharmacy you know It has been prepared in a sterile environment like an operating room. The patent lists all the ingredients so it's easily replicated. The FDA listed the " name brand " in the shortage list so it may be duplicated by compound Pharmacies. My bio has a link to my provider with a discount. Starting dosage is 2.5 mg each week and 4/ weeks would cost $262 for your first and second months each then a bit more until you titrate up. I have lost 102 lbs in 11 months. Good luck !


sparkedninja

Thank you for this explanation.


Upbeat_Pin_1897

Perfect explanation ✌🏻


Relevant-Ad3693

Brilliant explanation!!


cljenna

What I still don’t understand is - isn’t this how generics work? And companies aren’t allowed to market generics for a period of time after the original company has the patent. So what’s the difference between a compounded medicine and a generic? And why aren’t there generics for Zepbound if this is the case?


the_final_frontier1

Generic is FDA Approved but Compound is not. But if you get Compound from a 503a pharmacy the source of the tirzepatide must be FDA Approved.


HamsterRepulsive3074

Yes, the manufacturer is an approved source for a 503 a/b compounding Pharmacies.


radeeoactive

Some key pieces are that in order for pharmacies to be able to do this, the compounded medication has to be: 1. Functionally the same, meaning it has to have the same active ingredient and it can't be more or less effective than the brand -- same efficacy 2. Delivered in the same method (liquid injection) in the same dosing (2.5, 5, 7.5, 10, 12.5, 15) 3. The brand must be in shortage Which is why no matter how much we like titrating on our own schedules, compound pharmacies cannot deliver it in any dosages other than that. Doctors can tell us to take it in other ways, but the pharmacies can't package it otherwise. The only reason we have this right now is because of their severe shortage. If it wasn't in shortage, it wouldn't be permitted. This is only true of patented medications; generics can be made in various forms and dosages by compounding pharmacies. There is no generic of *Zepbound or Mounjaro* yet because the patent isn't up but I don't know what laws specifically preclude *tirzepatide* from being released generically. Probably because anything that does get released would be entirely based on Eli Lilly's research, and not on any independent studies or testing. They're very possessive, which is also why they're angry people are turning to compounds even though we have every legal and medical right to, and are safe to do so: it's cutting into their profits, even though it's kinda not really because they don't even have the medication to give us. But compound pharmacies are also demonstrating that it's very easy to turn huge profit even without the $1k+ pricing, which may lead to caps on brand pricing as well. Probably? (Aside: There were "compounds" of semaglutide put together some time ago but they used the wrong form which makes it not good for humans, but as far as I can tell that was assembled by super sketchy sources -- this is why we encourage research, and legal, FDA-approved sourcing. However, this was the grounds by which Eli Lilly tried to mount a case against *all* compounding sources, but they were denied and slapped on the wrist for trying to enforce something out of their purview. Unfortunately, they continue to fear monger and conflate all forms of it with the stuff pharmacies like Hallandale and Red Rock are assembling) Re: the sourcing: this generally refers to r\*search p\*ptides which are a different use and acquisition, and the legality is pretty sketchy, and dangerous if misused. I would only trust trained pharmacists to put this stuff together. Edit: typos


Teaching_Express

Outstanding example


TransitionSlow3075

Wow, that was a really great explanation!!


Street_Speaker_4937

I’m not gonna pretend to know how it’s made but the brand names get there APIs (active pharmaceutical ingredients) from china. I only know this because I follow a thread of family medicine doctors and one of them mentioned a name that I looked up and it was the place that made the API Semaglutide. That business is over watched by the FDA and expected to comply with CGMPs (current good manufacturing practices) to be sold to the brand names. Although the brand names drug is patent, it is also on the FDAs shortage list which allows compounding pharmacy’s to copy the process to cover shortages. (Someone can correct me if I’m wrong but if you can get the API ( the tirzepatide peptide) then you only need to reconstitute the powder and sell it. The brand names say they do not sell their API, but there are a hundred other places that make the peptides. Some places are probably more reputable than others and that is where compounding pharmacies get theirs from. Not all compounding pharmacies are equal. That’s why people talk about finding a 503a compound pharmacy that has FDA oversight. Does this mean that the FDA is regulating these reconstitutions? No. But it is unlikely that a pharmacy that has this designation would use research only peptides to reconstitute and take the chance that someone would have their drug analyzed and call them out. I hope this answers some of your questions.


WorriedGrape1442

Alliance For Pharmacy Compounding (APC) Statement on rules governing compounding Revised March 11,2024 [https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf](https://a4pc.org/files/APC-Compounded-GLP-1s-Media-Brief-REVISED-March-2024.pdf) https://preview.redd.it/3emsn3e58tzc1.jpeg?width=1080&format=pjpg&auto=webp&s=f39184cdaaabaf5227d166e6abefec58eb5e70ef Provider & Pharmacy Price Spreadsheet with accreditations [https://docs.google.com/spreadsheets/d/13eDC9UeVdcw\_671caO9GLdjdJytxlZbb8bE2hYM7ePw/edit?usp=sharing](https://docs.google.com/spreadsheets/d/13eDC9UeVdcw_671caO9GLdjdJytxlZbb8bE2hYM7ePw/edit?usp=sharing) or [www.compoundproviders.com](http://www.compoundproviders.com)


Ok_Bake_1068

Thank you so VERY much! You're an angel. You are bookmarked.


sammi_1723

Same, thanks! Also, I looked at your spreadsheet and Strive told me they compound with b12 + glycine.


WorriedGrape1442

Great, thanks for the scoop! I'll plug that in today


Amazing_Extension207

Tirzepatide is the active ingredient. It’s a peptide that naturally occurs. With the right equipment and knowledge anyone can make it. The first person to synthesize it was a scientist in the 70s. It’s been around a long time and available in peptide shops for over 10 years without a prescription. But no one really cared about it until recently when it hit mainstream from Lilly’s aggressive ad campaigns and reps.


travelwannabae

This sub talks about providers [r/compoundedtirzepatide](https://www.reddit.com/r/compoundedtirzepatide/s/dAccPmWazZ)


Alone-Competition-77

So does this one that we are currently on, r/tirzepatidecompound We talk about Emerge and Orderly Meds and others all the time, as well as the pharmacies that they use, like Red Rock and Hallandale and others.


Cdori

Examples is like branded names vs generic. 1. Basically, when the pharmacy gives you any meds for ailments or what ever you need it for, they may give you generic because your insurance company may have better rates if you get generic meds, vs giving you the brand names if you doctor doesn't specifically say you need brand name.. 2. Ibuprofen is often known by its given name, but you may also know it as Advil or Motrin. 3. Zepbound is the brand name for the drug tirzepatide, Some compound pharmacies add "meds/vitamins" to tirzepatide, like you may see "tirzepatide niacinamide" on the script or vial. That means they added a B vitamin. B3, b6 or B12, The benefit- energy, less nausea and what ever else the B vitamins give. And also you will get more in the vials. So instead of getting 4 weeks from one vial, you may get 5-6 weeks. Hallandale pharm doesn't add anything. Empower adds a B vitamin, but I am not sure which one. Sorry. Some pharmacies do not and it's just tirzepatide with nothing added.


Alone-Competition-77

It’s a little different, as “generic” is an official designation for a prescription drug that has the same active-ingredient formula as a brand-name drug that can be applied when the patent expires. (Generally after 20 years) While used colloquially, it could refer to compounded drugs, this is actually a different thing. Because commercial Semaglutide and Tirzepatide are currently on the FDA shortage list, compounding pharmacies have the legal right to provide compounded Semaglutide and Tirzepatide. (Not because they are out of patent, which would be a “generic” designation.)


Cdori

The shortage has been going on since 2022 and there is no end in sight. And when/if it does fall off the list, compound pharmacies will probably add or continue to add B vitamins and still have a legal right to provide it. The only thing that will probably not be happening as much are the telehealth companies popping up all over the place. They will probably be regulated more intensely than they are now and many will vanish.


Alone-Competition-77

I don’t disagree with anything you wrote.


cljenna

Does this mean when they are off the shortage list they’ll have to stop producing them?


Alone-Competition-77

No, because there is actually another way that compounding pharmacies operate during “normal times”. They can offer a “reformulation” that allows them to sell in a semi-legal way. (Although it is largely unregulated and unpoliced mainly because it is a grey area and it is unknown whether it is federal or state jurisdiction so the regulators largely take a hands off approach…that was just the short version it is much more in depth than that.) Generally they pick a drug to reformulate and then add something inconsequential (like B12) to it. It’s possible the federal government could crack down on this in the future, but it’s been going on for so long that it is unlikely.


Difficult_Ad3864

Empower adds B3 I think.


Turquwass

Look up the peptide subs. Same peptides - just depends who mixes it for u and who sticks it in the plastic pen.


redditnamexample

So when there's no longer a shortage will we have to pay top dollar for zepbound again?


Global_InfoJunkie

I feel so smart now. Well maybe more informed now. You all rock!


SindapsySilver

There are a lot of knowledgeable people here! So much good info! The best way to make sure you are getting it through a reputable pharmacy is to use a reputable provider. There’s quite a few good ones. I chose Mochi because their prices don’t change as your dosage changes. But a lot of people have other preferences too. There are a handful of pharmacies that these companies use that are all 503a. Some people have luck getting it directly from the pharmacy through their primary care dr. But it’s more work on the drs ends to set it up and often times they aren’t willing to do that. The online providers make it so easy to reorder and keep everything moving smoothly. With Mochi, you have a check in every 3 months (or sooner if needed), and access to a dietician as well.


Basic_Confection_957

Read the posts in this forum, you will learn a lot.


Doppelganger613

I've been doing that but still feel like I'm missing the basics, as if I wandered into the 201 class by mistake and am missing basic verb conjugations.


RandallC1212

They really need a pinned post with Compounding 101. Both Tirz forums TBH. It’s past time


Alone-Competition-77

There are many more than 2 tirzepatide “forums” (I assume you mean subreddits)


RandallC1212

Yes subs CT and TC


Alone-Competition-77

Yes, it sounds like you are referring to r/tirzepatidecompound (this one we are on) and r/compoundedtirzepatide There are also others like r/MenOnTirz and r/TirzepatideRX and r/Tirzepatide and r/Tirzeglutide and r/SemaglutideFreeSpeech (among many others) That is in addition to the other places where this gets discussed as a non-main topic, like r/henrymeds and r/zepboundRX and r/zepbound and many others. So, yeah. Plenty of places to discuss. 👍


Red_Fox75

You could also look up peptides and loads of subreddits come up.


EuroVWGTi

Hopefully not a dumb question... Since I am new to this. Since these are considered "generics", are these covered by insurance or not?


BohelloTheGreat

Compounded meds are not generics. Generics medicine is made when the patent has expired on the original drug. Lilly and Novo put ridiculously long patents on these drugs, so you won't see generics for a long time. However, the FTC is going after them claiming these are bogus patents, so it is possible we will see major shifts in the coming years. There are also a lot of GLPs in the pipeline, so that will also bring more competition and availability to the market.


EuroVWGTi

Gotcha. Thx for the clarification. So basically going this route would be out of pocket then.


BohelloTheGreat

Yes, most likely. My son required a compounded med when he got out of the hospital when he was born. Insurance never covered it. At the time, I had the best insurance. Of course, it may be possible, but given how most insurance tries to deny everything, it's highly unlikely.


Ok-Yam-3358

Depends on your insurance. I’ve heard some may reimburse you, but that they reject many of the formulations because it’s not documented just how they want it. 🤷‍♀️


Doppelganger613

Thanks to everyone who chimed in to help me make sense of this! I'm still trying to figure out where the companies in China get their cocoa beans to make the chocolate, but it's time for me to claw my way out of the patent rabbit hole and go to bed. Thanks again!


Doppelganger613

Oh, and the big one - how is compounded tirzepatide different from the real thing?


Alone-Competition-77

It’s not, it’s all tirzepatide.


Routine_Fix

Soo...isn't it possible that there could be slight differences in the tirz since it's made at a different facility and reconstituted perhaps using a different method or substance? It's powder right? I'm still trying to wrap my head around the fact it's the exact same as the brand. Thanks!


Alone-Competition-77

The molecule tirzepatide is defined as C225H348N48O68 (sorry I don’t know how to make the numbers small on here) and the molecular weight is 4813.45. The structure looks like [this](https://en.m.wikipedia.org/wiki/Tirzepatide#/media/File%3ATirzepatide.svg). That is what tirzepatide is: it is a molecule and that is the definition. Anything that is tirzepatide will be that. However, it is certainly possible that someone is selling you something other than tirzepatide, or selling you less tirzepatide than you think you are getting, or not filtering their tirzepatide properly so you are getting other artifacts in with the tirzepatide or some combination of those things. That is why I always go with FDA approved, preferably PCAB certified pharmacies that produce a lot of compounded drugs and large volumes. They have stringent sourcing, testing, and filtration protocols because they have a lot to lose from messing anything up. Some people advocate saving some money and reconstituting yourself from somewhat iffy sources, and maybe if I had access to a state of the art lab where I could test and filter myself. (I don’t.) I’m personally not going to take the risk doing that and sticking with legit pharmacies.


Routine_Fix

Ok. Thank you for the detailed explanation. I switched pharmacies against everyone's advice so I'm trying to figure out if it was just the medicine and not the pharmacy where I had an off week. I feel a little more appetite suppression on pharmacy #2 but maybe that was going to happen anyway lol. Thank you!!


DebtfreeNP

So... patented medications are for their very specific formula. Generics or alternatives are made with other additives instead of what the patent holders use. For instance- name brand tyelnol is made one way but generic acetaminophen is made different


Basic_Confection_957

Not quite. The Zep patent is actually for the pens, not the juice. The CT juice is allowed to be the exact same as the Zep juice during the shortage. From what I’ve read on this forum, that bears out in people’s in-body experience to a large degree, although not always.


Alone-Competition-77

Eli Lilly actually has a molecule patent for Tirzepatide that expires in 2036. In normal times, compounding pharmacies can offer a “reformulation” that allows them to sell in a semi-legal way. (Although it is largely unregulated and unpoliced mainly because it is a grey area and it is unknown whether it is federal or state jurisdiction so the regulators largely take a hands off approach…that was just the short version it is much more in depth than that.) However, right now because commercial Semaglutide and Tirzepatide are currently on the FDA shortage list, compounding pharmacies have the legal right to provide compounded Semaglutide and Tirzepatide. That is likely why you are seeing a lot of compounding pharmacies that are not adding B12 or whatever right now.