Is a Generic Tirzepatide Closer Than Anyone Expects?

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Mounjaro and Zepbound: Cheaper Generic GLP-1 Options Could Arrive Soon



US regulators have agreed to look at a Swiss drugmaker's filings for cheaper generic copies of both Zepbound and Mounjaro.

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www.healthline.com
 
I was under the impression peptides can't be patented, seeing as they come from natural materials? So what precisely is covered by their patent? And is there a generic sema on the market yet?
 
BigJDog said:

I was under the impression peptides can't be patented, seeing as they come from natural materials? So what precisely is covered by their patent? And is there a generic sema on the market yet?
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Semaglutide's patent has already lapsed in a number of countries (the US is not one of them).

United States — 2032; China — 2026; Brazil — March 2026; Canada — January 2026; India — 2026
 
I'm 10000% certain Lily has the money to stop this ever winning approval, at least not before the Tirz patent lapses here. By then, Reta will probably have shoved Tirz out of the way.
 
I don't claim much knowledge of US patent law, but here's what Gemini has to say:

Tirzepatide is a synthetic peptide drug — the brand names are Mounjaro and Zepbound. It carries a stack of patents plus regulatory exclusivities. The core composition patent on the molecule (US 9,474,780) doesn't lapse until January 5, 2036. [1, 2, 3, 4, 5]

The Patent and Exclusivity Picture

  • Compound Patent: The main patent shielding the active ingredient [tirzepatide] (US 9,474,780) runs out in 2036. [1]
  • Formulation & Delivery: Lilly also owns a pile of follow-on patents covering peptide stability and devices such as the auto-injector pen. [1, 2]
  • Regulatory Exclusivity: Approved in 2022 as a novel chemical entity, it is walled off from ordinary generic competition by regulatory exclusivities. [1, 2, 3, 4, 5]
 
Brandon556 said:

It began life as a generic. I still can't work out how they managed to get a patent on it
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Semaglutide (Ozempic/Wegovy) derives from the natural hormone GLP-1, though it carries modifications that make it more stable and longer-acting. That tweak is the loophole big pharma uses to get around the fact that the peptide is natural, and patent it.

Eli Lilly is in court attempting the same trick with Retatrutide. Should they win, the peptide is theirs for 12 years before compounding companies would be allowed to make Reta.
 
Don't expect a generic tirz any time soon. Companies file generic formulation paperwork well in advance so they're positioned to launch the moment the patent lapses…2030something
 
BigJDog said:

I was under the impression peptides can't be patented, seeing as they come from natural materials? So what precisely is covered by their patent? And is there a generic sema on the market yet?
Click to expand...
Today's GLP1 agonists are entirely lab-made molecules. They don't occur in nature. Which is precisely why they can be patented. The primary patent covers the peptide sequence as such, but plenty of secondary ones sit alongside it — formulation, synthesis routes, dosing, method-of-use, the injecting device and so on. It amounts to an entire bundle of patents.
 
professorpeppy said:

someone school me here.. if tirz is under patent, how on earth are we able to buy grey??

apologies if that's a daft question
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Whoever's manufacturing the grey is based in China, and US patents mean nothing to them.
 
A patent only gets granted if the crucial details all sit in the application paperwork.

So the odd upshot is that the patent ends up helping the illegal manufacturers.
 
Enyola said:

A patent only gets granted if the crucial details all sit in the application paperwork.

So the odd upshot is that the patent ends up helping the illegal manufacturers.
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right, i had no idea, patent law isn't really my area. cheers!
 
professorpeppy said:

Enyola said:

A patent only gets granted if the crucial details all sit in the application paperwork.

So the odd upshot is that the patent ends up helping the illegal manufacturers.
Click to expand...
right, i had no idea, patent law isn't really my area. cheers!
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I know, right! Here's the precise recipe and process we use to produce something….just don't copy us! Patents only cover individual countries tho, so nothing stops a different country going ahead with it. I keep trying to explain to my wife that Reta lacking fda approval has far more to do with $$ than with safety
 
BigJDog said:

professorpeppy said:

Enyola said:

A patent only gets granted if the crucial details all sit in the application paperwork.

So the odd upshot is that the patent ends up helping the illegal manufacturers.
Click to expand...
right, i had no idea, patent law isn't really my area. cheers!
Click to expand...
I know, right! Here's the precise recipe and process we use to produce something….just don't copy us! Patents only cover individual countries tho, so nothing stops a different country going ahead with it. I keep trying to explain to my wife that Reta lacking fda approval has far more to do with $$ than with safety
Click to expand...
Uh, safety is the whole point. Lilly is throwing fat, fat stacks of cash at getting FDA approval as fast as it can, but nothing replaces time when it comes to proving a drug is safe and works.
 
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