5 ms·

2031 is when it becomes entirely (in the US) unencumbered by patents for its use in weight loss according to Wikipedia. The initial patents seem to date to ~20

2031 is when it becomes entirely (in the US) unencumbered by patents for its use in weight loss according to Wikipedia. The initial patents seem to date to ~2008 which means that as of 2028 the synthesis will be free of patents, but you won't be able to market a generic for weight loss until the non-exclusivity period ends. [1] There are already "compounding" pharmacies in the US that sell it cheaper; I can't seem to find a straight answer on what the hell this means though. [1] https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity https://www.fda.gov/drugs/development-approval-process-drugs... if you're interested in the FDA's summary -- I found this to be almost entirely useless though.

simoncion 2y ago
> ...I can't seem to find a straight answer on what the hell this means though. This may help to explain it: <https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole>.
- andrewla 2y ago
  In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies: > There are now around ~20 FDA licensed facilities that have a DMF for the active pharmaceutical ingredient (API) Semaglutide including: Bachem AG (Switzerland), Ambiopharm (South Carolina, USA), etc. > Novo Nordisk does not sell bulk Semaglutide API to compounding pharmacies, and while they are 100% the only licensed source for Ozempic & Wegovy, there are other licensed API manufacturers that work on the active ingredients and excipients used by compounding pharmacies. > Any API used in sterile compounding is required to come from an FDA licensed manufacturer. I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk? And if they are doing it extrajurisdictionally, how on earth is it getting back into the US and sold to customers without the FDA police knocking down doors? I've talked to survivalists who get their tubs of antibiotics by buying fish azithromycin in bulk from veterinarian suppliers -- are we going to be buying horse Ozempic next?
  - vundercind 2y ago
    > I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk I don’t think (many? Most? All?) of the drugs in this class are patent-encumbered. They’ve been around for a while. … application as a weight loss drug is patented. That’s new. You can’t package and sell them to fill a weight loss prescription if you’re not allowed to by the patent holder. So it stands to reason that the factories that make the chemical can sell it to whoever they want, as long as the buyer is permitted to receive drugs and such in the first place. The drugs themselves, the actual chemical, isn’t what’s covered by the patent. The compounding’s legality is covered by the Codex post: compounding pharmacies are allowed to package and sell drugs that are on the FDA’s shortage list, regardless of patents that would ordinarily prevent selling them. These drugs (various glp-1 agonists) are on the shortage list. So, that part’s fine too.
    - andrewla 2y ago
      The initial patent for semaglutide specifically was issued in 2008 and is under protection for 20 years -- while liraglutide has been around for much longer, semaglutide is relatively new in patent terms. So presumably the licensed DMF facilities are operating under a license from Novo Nordisk, because otherwise they'd be shut down. But why do the terms of the license allow them to sell to anyone else? You are correct that the use specifically for weight loss is newer and the FDA's labyrinthine procedures give Novo Nordisk exclusivity for a significant amount of time after that.
      - simoncion 2y ago
        > In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies I disagree. Alexander mentions several other compounding pharmacies that will sell you the same medication if you present a subscription, so it's not just one place that's selling this stuff: > HenryMeds is $297/month, Eden is $296, Mochi is $254... You probably do not know this, but the fellow has been a psychiatrist for a decade or more. He's also aware of the business and regulatory side of the medical profession, so I expect the assertion that "But the law says that compounding pharmacies are allowed to step in and compete with Big Pharma during a shortage." is true and accurate. The Reddit post claims a source for the chemicals, but the explanation about what compounding pharmacies are doing during times of medication supply shortage and how they can legally do it come from industry knowledge. > But why do the terms of the license allow them to sell to anyone else? Likely because the FDA permits compounding pharmacies to sell Big Pharma drugs when there's a shortage of them. If compounding pharmacies can get reliable access to the same chemicals that Big Pharma is selling, then the bottleneck is somewhere in Big Pharma's side of the machine (rather than the chemical "feedstock" production side), and the FDA has a strong interest in permitting entities that can take up the slack to do so. I can't imagine the FDA has any interest at all in undermining its ability to solve drug shortages by enlisting secondary drug manufacturers, so I expect any "feedstock" production agreements must not restrict the ability for the "feedstock" producer to sell to secondary drug manufacturers when the FDA deems it necessary to permit them to sell products from that "feedstock".

simoncion 2y ago

> ...I can't seem to find a straight answer on what the hell this means though. This may help to explain it: <https://www.astralcodexten.com/p/the-compounding-loophole https://www.astralcodexten.com/p/the-compounding-loophole>.

andrewla 2y ago
In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies: > There are now around ~20 FDA licensed facilities that have a DMF for the active pharmaceutical ingredient (API) Semaglutide including: Bachem AG (Switzerland), Ambiopharm (South Carolina, USA), etc. > Novo Nordisk does not sell bulk Semaglutide API to compounding pharmacies, and while they are 100% the only licensed source for Ozempic & Wegovy, there are other licensed API manufacturers that work on the active ingredients and excipients used by compounding pharmacies. > Any API used in sterile compounding is required to come from an FDA licensed manufacturer. I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk? And if they are doing it extrajurisdictionally, how on earth is it getting back into the US and sold to customers without the FDA police knocking down doors? I've talked to survivalists who get their tubs of antibiotics by buying fish azithromycin in bulk from veterinarian suppliers -- are we going to be buying horse Ozempic next?
- vundercind 2y ago
  > I confess that I'm more confused than when I started -- why can these companies get away with selling it to any party other than Novo Nordisk I don’t think (many? Most? All?) of the drugs in this class are patent-encumbered. They’ve been around for a while. … application as a weight loss drug is patented. That’s new. You can’t package and sell them to fill a weight loss prescription if you’re not allowed to by the patent holder. So it stands to reason that the factories that make the chemical can sell it to whoever they want, as long as the buyer is permitted to receive drugs and such in the first place. The drugs themselves, the actual chemical, isn’t what’s covered by the patent. The compounding’s legality is covered by the Codex post: compounding pharmacies are allowed to package and sell drugs that are on the FDA’s shortage list, regardless of patents that would ordinarily prevent selling them. These drugs (various glp-1 agonists) are on the shortage list. So, that part’s fine too.
  - andrewla 2y ago
    The initial patent for semaglutide specifically was issued in 2008 and is under protection for 20 years -- while liraglutide has been around for much longer, semaglutide is relatively new in patent terms. So presumably the licensed DMF facilities are operating under a license from Novo Nordisk, because otherwise they'd be shut down. But why do the terms of the license allow them to sell to anyone else? You are correct that the use specifically for weight loss is newer and the FDA's labyrinthine procedures give Novo Nordisk exclusivity for a significant amount of time after that.
    - simoncion 2y ago
      > In the end this comes down to a Reddit post from Henry's, one of the online compounding pharmacies I disagree. Alexander mentions several other compounding pharmacies that will sell you the same medication if you present a subscription, so it's not just one place that's selling this stuff: > HenryMeds is $297/month, Eden is $296, Mochi is $254... You probably do not know this, but the fellow has been a psychiatrist for a decade or more. He's also aware of the business and regulatory side of the medical profession, so I expect the assertion that "But the law says that compounding pharmacies are allowed to step in and compete with Big Pharma during a shortage." is true and accurate. The Reddit post claims a source for the chemicals, but the explanation about what compounding pharmacies are doing during times of medication supply shortage and how they can legally do it come from industry knowledge. > But why do the terms of the license allow them to sell to anyone else? Likely because the FDA permits compounding pharmacies to sell Big Pharma drugs when there's a shortage of them. If compounding pharmacies can get reliable access to the same chemicals that Big Pharma is selling, then the bottleneck is somewhere in Big Pharma's side of the machine (rather than the chemical "feedstock" production side), and the FDA has a strong interest in permitting entities that can take up the slack to do so. I can't imagine the FDA has any interest at all in undermining its ability to solve drug shortages by enlisting secondary drug manufacturers, so I expect any "feedstock" production agreements must not restrict the ability for the "feedstock" producer to sell to secondary drug manufacturers when the FDA deems it necessary to permit them to sell products from that "feedstock".