Mounjaro generics — when can they launch?
Mounjaro (TIRZEPATIDE) · Eli Lilly · 216 active US patents · 0 expired
Where Mounjaro sits in the generic timeline
Long-dated protection: earliest active US patent for Mounjaro extends to 2036 (~10 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 144 patents
- Formulation — 42 patents
- Composition of Matter — 30 patents
FDA U-codes carved out by Mounjaro patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-4374 | (no description) |
U-4377 | (no description) |
U-3855 | (no description) |
U-4376 | (no description) |
U-4386 | (no description) |
U-4375 | (no description) |
U-4383 | (no description) |
U-4378 | (no description) |
U-4380 | (no description) |
U-4384 | (no description) |
U-4381 | (no description) |
U-4379 | (no description) |
U-4229 | (no description) |
U-4228 | (no description) |
U-4400 | (no description) |
U-4401 | (no description) |
U-4232 | (no description) |
U-4230 | (no description) |
U-4410 | (no description) |
U-4311 | (no description) |
Sample patent estate
Showing 6 of 216 active US patents. View full estate on the Mounjaro drug page →
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This patent protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
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Eli Lilly and Co's patent US 9474780 protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
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Eli Lilly and Co's patent US 9474780 protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
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Eli Lilly and Co's patent US 9474780 protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
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Eli Lilly and Co's patent US 9474780 protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
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Eli Lilly and Co's patent US 9474780 protects dual incretin peptide mimetic compounds that agonize both GIP and GLP-1 receptors.USPTO title: GIP and GLP-1 co-agonist compounds
Sources
- FDA Orange Book — patents listed against Mounjaro (NDA filed 2022)
- Mounjaro drug profile — full patent estate, indications, clinical trials, pricing
- Eli Lilly patent portfolio
- Patent cliff 2036 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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