Should have added that additional FDA indications for a drug can extend the clock on a drugs patent and market exclusivity time… But the point remains the same. A biologic designation extends the initial clock from 5 years of exclusivity to 12 years
I should also clarify that the patent can be challenged at any time, but regardless the outcome, the market exclusivity still governs when it could ultimately be brought to market as a generic if a patent challenge succeeds. If that makes sense.
When the FDA grants another “indication”, ie a new approved use, the patent and exclusive time can be extended by three years, but only for that indication. In other words the clock started on Tirzepatide for diabetes in 2022, for obesity in late 2023, and so on for the new indications. This is my understanding anyways.
Great insights. I am certainly sensitive to drug companies, needing to take whatever steps to protect their intellectual property and the results of their R&D. If it wasn’t the fact that these medications are so obscenely expensive and not frequently covered by insurance, I’d be OK with their need for protection. But the entire GLP-1 movement has significantly exposed all the flaws in the US pharmaceutical business, including the pharmacy benefit managers.
“This just in… Eli Lilly SUES GOD, seeking a ‘Mana from Heaven’ designation for Retatrutide.” 😯 “God is said to be not amused, and seeking legal counsel.” “Meanwhile, swarms of locusts spotted en route to Lilly’s Indianapolis headquarters, as well as massive storm clouds. Lilly CEO David Ricks insisted there’d be no impact on Q3 earnings.” “Back to you in the studio, Stephanie.” ⚡️🦗
*Sidenote:* Considering the savings card changes, and that many of us on the card will likely be *paying 650 for name-brand come January 2025* (unless you’re on low-dose vials)… a nice vid and poll question might be, “Do you intend to GO TO COMPOUND COME 2025, in response to the likely savings card price increase?” 🤔 (I know I’m sure thinkin’ about it.)
Right - basically the injector pen and dosing scheme. The molecule existed prior to Eli Lilly deciding to run trials on it. They didn’t invent the peptide.
Suing the FDA? Isn’t the older glp1, a daily shot off of patent now and generic is available and cost has not come down at all? Generics don’t seem to be the relief we need from the soaring cost of GLP1s. Everyone has been waiting for these drugs to come off patent but if the price doesn’t change, how does that benefit the patients? Is this mostly because Lilly will not longer be able take all the money for the drug, but other companies would be able to manufacture it as a generic, price it just as high and the other companies pull in that money? I don’t think that retatrutide could be considered a biological, could it?
The price for generic Liraglutide (Victoza) *has* come down a lot… just weirdly very selectively is all. 😒 AKA only at Rite Aid and Walgreen’s, and with a GoodRx coupon. Still priced nearly as high as ever everywhere else. 🤷🏽
You can buy either 2 pens (30 days of 1.2mg), or 3 (30 days of 1.8mg): Rite Aid w/GoodRx: $165/$245. Walgreens w/GRX: $225/$335. Everywhere else: $450+/$650+ Go figure. 🤷🏻♂️ But it is a good deal for T2D ppl w/out insurance… if they know where/how to buy.
Sorry. The brand that was FDA approved was Redux,a similar diet drug that had the same serious side effects and was later withdrawn from the market at the FDA request.
It’s funny how many people think that these are “natural peptides” that already existed and pharma just snatched them up to gatekeep them. No, Lilly and their scientist invented the Tirzepatide molecule, paid hundreds of millions to develop it, and only have 5 years of guaranteed market exclusivity on it.
I think this has much more to do with compounding than patent exclusivity. Biologics do not qualify for exemptions under 503a and 503b, so compounders could not sell reta even if there were shortages.
Forget Reta Who Tide I want some of those trials those execs are injecting in their brains so I can predict the next Mega #’s. This is ingenious they thought to do this. ❤
Hi Dave. I’ve lost 90 pounds on Terzepitide before a stall. I was just prescribed compounded Retatrutide by my physician and started a week ago with a low dose. Looks like I will lose quickly from it. I know it’s not fda approved but if compounded Terzepitide stops being available this still should be for a couple of years I’m hoping until fda approval. There are unknowns but it’s the known consequences of obesity that bother me more.
No compounded medications are FDA approved. They don’t always get it right, remember fen-phen? It’s all a risk that is unknown but the risks of obesity are known. The benefits outweigh the risks. These are peptides, not hard core drugs. I am watching the trials closely and I am under a doctor’s prescription and supervision.
Yeah… fen-phen was never FDA approved. Those two drugs were never tested together and FDA-approved to be used in combination. Compare that to say Contrave or Qsymia, which are dual-drug anti-obesity treatments that *were* tested and did get FDA approval. (And never had the level of issues fen-phen did.)
Express scripts is out of the 10 mg Zepbound. They had me call 3 in network pharmacies in My small city in North Dakota and luckily the last one had it. Lili is lying!
