Krazati generics — when can they launch?
Krazati (ADAGRASIB) · Bristol-Myers Squibb · 4 active US patents · 0 expired
Where Krazati sits in the generic timeline
Long-dated protection: earliest active US patent for Krazati 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.
- Method of Use — 2 patents
- Composition of Matter — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Krazati 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-3490 | (no description) |
U-3953 | (no description) |
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Krazati drug page →
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This patent protects compounds that irreversibly inhibit the activity of KRas G12C and methods of using them.USPTO title: KRas G12C inhibitors
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This patent protects methods of treating KRas G12C cancers using a combination of a pan ErbB family inhibitor and a KRAS G12C inhibitor.USPTO title: Combination therapies
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USPTO title: Crystalline forms of a KRas G12C inhibitor
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This patent protects solid pharmaceutical compositions of adagrasib for oral dosage to treat cancer, as well as methods for manufacturing and treating cancer.USPTO title: Adagrasib solid pharmaceutical compositions
Sources
- FDA Orange Book — patents listed against Krazati (NDA filed 2022)
- Krazati drug profile — full patent estate, indications, clinical trials, pricing
- Bristol-Myers Squibb 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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