PEXIDARTINIB HYDROCHLORIDE generics — when can they launch?
PEXIDARTINIB HYDROCHLORIDE (PEXIDARTINIB HYDROCHLORIDE) · · 24 active US patents · 0 expired
Where PEXIDARTINIB HYDROCHLORIDE sits in the generic timeline
Imminent generic cliff: earliest active US patent for PEXIDARTINIB 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 — 12 patents
- Method of Use — 8 patents
- Formulation — 4 patents
FDA U-codes carved out by PEXIDARTINIB 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-2606 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the PEXIDARTINIB HYDROCHLORIDE drug page →
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
-
This patent protects compounds that modulate c-fms and/or c-kit activity, including compositions and methods for treating diseases or conditions mediated by these proteins.USPTO title: Compounds modulating c-fms and/or c-kit activity and uses therefor
Sources
- FDA Orange Book — patents listed against PEXIDARTINIB HYDROCHLORIDE (NDA filed 2019)
- PEXIDARTINIB 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.
Get generic entry alerts
Free Pharma CI alerts on PEXIDARTINIB HYDROCHLORIDE — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →