Could generic Tirzepatide be coming sooner than we think?

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Mounjaro, Zepbound: Generic GLP-1 Drugs May Soon Be Available



Federal regulators have agreed to review a Swiss pharmaceutical company's applications for two cheaper generic versions of Zepbound and Mounjaro.

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www.healthline.com
 
I thought you couldn’t patent peptides because they are made from natural materials? What exactly do they hold the patent on? Is there generic sema yet?
 
BigJDog said:


I thought you couldn’t patent peptides because they are made from natural materials? What exactly do they hold the patent on? Is there generic sema yet?

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The patent on semaglutide expired in some countries (but not the US).

United States2032China2026BrazilMarch 2026CanadaJanuary 2026India2026
 
I am 10000% confident in Lily's ability to pay to make sure this never gets approved, at least until the Tirz patent expires here anyway. By that time, Reta will likely have pushed Tirz aside.
 
I don’t know a lot about patent law in the US, but this is what Gemini says:

Tirzepatide is a synthetic peptide drug (marketed as Mounjaro and Zepbound). It is protected by multiple patents and regulatory exclusivities. Its core composition patent (US 9,474,780) does not expire until January 5, 2036. [1, 2, 3, 4, 5]

Patent & Exclusivity Landscape

  • Compound Patent: The primary patent protecting the active ingredient [tirzepatide] (US 9,474,780) expires in 2036. [1]
  • Formulation & Delivery: Eli Lilly also holds numerous follow-on patents covering peptide stability and delivery devices like the auto-injector pen. [1, 2]
  • Regulatory Exclusivity: As a novel chemical entity approved in 2022, it is safeguarded from traditional generic competition through regulatory exclusivities. [1, 2, 3, 4, 5]
 
Brandon556 said:


It started as generic. I still dont understand how they were able to patent it

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Semaglutide (Ozempic/Wegovy) is based on the natural hormone GLP‑1 but contains modifications that improve stability and duration of action. This modification is how big pharma bypasses the peptide being natural and can patent.

Eli Lilly is in court trying to do this with Retatrutide. If they succeed, then they have this peptide locked down for 12 years before compound companies can manufacture Reta.
 
No chance of generic tirz anytime soon. They file for generic formulations ahead of time so they can be among the first companies to come out with a generic when the patent expires…2030something
 
BigJDog said:


I thought you couldn’t patent peptides because they are made from natural materials? What exactly do they hold the patent on? Is there generic sema yet?

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Nowaday's GLP1-agonists are all molecules that were created in a lab. Don't exist in nature. So of course they can be patented. The main patent is the peptide sequence itself, but there are many secondary patents like the formulation, synthesis processes, dosing, method-of-use, the device for injecting etc. It's a whole bundle of patents.
 
professorpeppy said:


please educate me guys.. if there is a patent on tirz how the hell are we getting gray??

sorry if this is dumb

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The people making gray are in China and don’t care about the US patent.
 
To get a patent, all the important information needs to be in the papers for application.

So paradoxically, the patent itself helps illegal manufacturers.
 
Enyola said:


To get a patent, all the important information needs to be in the papers for application.

So paradoxically, the patent itself helps illegal manufacturers.

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ahh ok i didnt know this, not too brushed up on patent laws. thanks!
 
professorpeppy said:


ahh ok i didnt know this, not too brushed up on patent laws. thanks!

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I know right! Here is the exact formula and method we use to make something….now don’t copy us! Parents are only for each country tho so it doesn’t stop a different country from doing it. I’m trying to explain to my wife how Reta not being fda approved has a lot more to do with $$ than safety
 
BigJDog said:


I know right! Here is the exact formula and method we use to make something….now don’t copy us! Parents are only for each country tho so it doesn’t stop a different country from doing it. I’m trying to explain to my wife how Reta not being fda approved has a lot more to do with $$ than safety

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Uh, it has everything to do with safety. Lilly is dropping fat, fat stacks of cash to get it FDA approved as fast as possible, but there’s no substitute for time in proving safety and efficacy.
 
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