CAPMATINIB HYDROCHLORIDE generics — when can they launch?
CAPMATINIB HYDROCHLORIDE (CAPMATINIB HYDROCHLORIDE) · · 14 active US patents · 0 expired
Where CAPMATINIB HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for CAPMATINIB HYDROCHLORIDE expires in 2027 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.
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 — 6 patents
- Method of Use — 4 patents
- Formulation — 4 patents
FDA U-codes carved out by CAPMATINIB HYDROCHLORIDE 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-2813 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the CAPMATINIB HYDROCHLORIDE drug page →
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This patent protects imidazo[1,2-b][1,2,4]triazines and imidazo[1,2-a]pyrimidines, which are kinase inhibitors useful in treating cancer and other diseases.USPTO title: Imidazotriazines and imidazopyrimidines as kinase inhibitors
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This patent protects imidazo[1,2-b][1,2,4]triazines and imidazo[1,2-a]pyrimidines as kinase inhibitors for treating cancer and other diseases.USPTO title: Imidazotriazines and imidazopyrimidines as kinase inhibitors
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This patent protects imidazo[1,2-b][1,2,4]triazines and imidazo[1,2-a]pyrimidines as kinase inhibitors for treating cancer and other diseases.USPTO title: Imidazotriazines and imidazopyrimidines as kinase inhibitors
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This patent protects imidazo[1,2-b][1,2,4]triazines and imidazo[1,2-a]pyrimidines, which are kinase inhibitors useful in treating cancer and other diseases.USPTO title: Imidazotriazines and imidazopyrimidines as kinase inhibitors
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This patent protects dihydrochloric acid and dibenzenesulfonic acid salts of the c-Met kinase inhibitor capmatinib hydrochloride and processes for preparing them.USPTO title: Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same
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This patent protects dihydrochloric acid and dibenzenesulfonic acid salts of the c-Met kinase inhibitor capmatinib hydrochloride and processes for preparing them.USPTO title: Salts of 2-fluoro-N-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-B][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same
Sources
- FDA Orange Book — patents listed against CAPMATINIB HYDROCHLORIDE (NDA filed 2020)
- CAPMATINIB HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2027 — 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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