Ayvakit generics — when can they launch?
Ayvakit (AVAPRITINIB) · Blueprint Medicines · 29 active US patents · 0 expired
Where Ayvakit sits in the generic timeline
Long-dated protection: earliest active US patent for Ayvakit extends to 2034 (~8 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 — 24 patents
- Composition of Matter — 5 patents
FDA U-codes carved out by Ayvakit 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-3168 | (no description) |
U-2726 | (no description) |
U-3506 | (no description) |
Sample patent estate
Showing 6 of 29 active US patents. View full estate on the Ayvakit drug page →
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This patent protects compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to kit
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This patent describes compounds and compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to kit
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This patent describes compounds and compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to kit
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This patent describes compounds and compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to kit
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This patent protects compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to KIT
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This patent describes compounds and compositions useful for treating disorders related to mutant KIT.USPTO title: Compositions useful for treating disorders related to kit
Sources
- FDA Orange Book — patents listed against Ayvakit (NDA filed 2020)
- Ayvakit drug profile — full patent estate, indications, clinical trials, pricing
- Blueprint Medicines patent portfolio
- Patent cliff 2034 — 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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