Retevmo generics — when can they launch?
Retevmo (SELPERCATINIB) · Eli Lilly · 56 active US patents · 0 expired
Where Retevmo sits in the generic timeline
Long-dated protection: earliest active US patent for Retevmo extends to 2037 (~11 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.
- Other — 28 patents
- Method of Use — 22 patents
- Composition of Matter — 6 patents
FDA U-codes carved out by Retevmo 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-3450 | (no description) |
U-3951 | (no description) |
U-3949 | (no description) |
Sample patent estate
Showing 6 of 56 active US patents. View full estate on the Retevmo drug page →
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This patent protects a class of compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase.USPTO title: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
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This patent protects a class of compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase.USPTO title: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
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This patent protects a class of compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase.USPTO title: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
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This patent protects a class of compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase.USPTO title: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
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This patent protects a class of compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase.USPTO title: Substituted pyrazolo[1,5-A]pyridine compounds as RET kinase inhibitors
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This patent protects compounds that inhibit RET kinase and are useful in treating and preventing diseases associated with RET kinase, such as those caused by RET mutations.USPTO title: Substituted pyrazolo[1,5-a]pyridine compounds as RET kinase inhibitors
Sources
- FDA Orange Book — patents listed against Retevmo (NDA filed 2020)
- Retevmo drug profile — full patent estate, indications, clinical trials, pricing
- Eli Lilly patent portfolio
- Patent cliff 2037 — 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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