Gavreto generics — when can they launch?
Gavreto (PRALSETINIB) · Rigel Pharms · 6 active US patents · 0 expired
Where Gavreto sits in the generic timeline
Long-dated protection: earliest active US patent for Gavreto 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 — 5 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by Gavreto 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-2952 | (no description) |
U-2828 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Gavreto drug page →
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This patent protects compounds that inhibit the RET protein and its resistant mutants, as well as methods of using these compounds.USPTO title: Inhibitors of RET
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This patent protects methods for treating cancer with a RET alteration by administering a selective RET inhibitor, such as Compound 1, in a daily dose of 60-400 mg.USPTO title: RET inhibitor for use in treating cancer having a RET alteration
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This patent protects methods for treating cancer with a RET alteration by administering a selective RET inhibitor, such as Compound 1, in a daily dose of 60-400 mg.USPTO title: RET inhibitor for use in treating cancer having a RET alteration
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This patent protects methods for treating cancer with a RET alteration by administering a selective RET inhibitor, such as Compound 1, in a daily dose of 60-400 mg.USPTO title: RET inhibitor for use in treating cancer having a RET alteration
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This patent protects methods for treating cancer with a RET alteration by administering a selective RET inhibitor, such as Compound 1, in a daily dose of 60-400 mg.USPTO title: RET inhibitor for use in treating cancer having a RET alteration
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This patent protects various crystalline solid forms and salt forms of the free base pralsetinib.USPTO title: Solid forms of pralsetinib
Sources
- FDA Orange Book — patents listed against Gavreto (NDA filed 2020)
- Gavreto drug profile — full patent estate, indications, clinical trials, pricing
- Rigel Pharms 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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