Augtyro generics — when can they launch?
Augtyro (REPOTRECTINIB) · Bristol · 10 active US patents · 0 expired
Where Augtyro sits in the generic timeline
Long-dated protection: earliest active US patent for Augtyro extends to 2035 (~9 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.
- Composition of Matter — 4 patents
- Method of Use — 4 patents
- Formulation — 2 patents
FDA U-codes carved out by Augtyro 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-3755 | (no description) |
U-3961 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Augtyro drug page →
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This patent protects the active drug substance of Augtyro.
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This patent protects the active drug substance of Augtyro.
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This patent protects polymorphs of a specific compound useful in treating diseases like cancer in mammals, including humans.USPTO title: Diaryl macrocycle polymorph
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This patent protects polymorphs of the molecule (7S,13R)-11-fluoro-7,13-dimethyl-6,7,13,14-tetrahydro-1,15-ethenopyrazolo[4,3-f][1,4,8,10]benzoxatriazacyclotridecin-4(5H)-one.USPTO title: Diaryl macrocycle polymorph
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This patent protects polymorphs of the molecule (7S,13R)-11-fluoro-7,13-dimethyl-6,7,13,14-tetrahydro-1,15-ethenopyrazolo[4,3-f][1,4,8,10]benzoxatriazacyclotridecin-4(5H)-one.USPTO title: Diaryl macrocycle polymorph
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This patent protects polymorphs of a specific compound useful in treating diseases like cancer in mammals, including humans.USPTO title: Diaryl macrocycle polymorph
Sources
- FDA Orange Book — patents listed against Augtyro (NDA filed 2023)
- Augtyro drug profile — full patent estate, indications, clinical trials, pricing
- Bristol patent portfolio
- Patent cliff 2035 — 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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