Zelboraf generics — when can they launch?
Zelboraf (vemurafenib) · Hoffmann La Roche · 6 active US patents · 0 expired
Where Zelboraf sits in the generic timeline
All listed Orange Book patents for Zelboraf have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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 — 4 patents
- Method of Use — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by Zelboraf 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-2164 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Zelboraf drug page →
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This patent protects compounds that modulate protein kinases and methods for using these compounds to treat diseases associated with aberrant protein kinase activity.USPTO title: Compounds and methods for kinase modulation, and indications therefor
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This patent protects compounds and methods for modulating protein kinases, which can be used to treat diseases and conditions associated with aberrant protein kinase activity.USPTO title: Compounds and methods for kinase modulation, and indications therefor
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This patent protects compounds that modulate the Ret protein and methods for developing such compounds, including crystal structures of Ret surrogates.USPTO title: Compounds and methods for development of Ret modulators
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This patent protects compounds that modulate protein kinases and methods for using these compounds to treat diseases associated with aberrant protein kinase activity.USPTO title: Compounds and methods for kinase modulation, and indications therefor
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This patent protects a process for manufacturing the compound of formula (1) and the compound of formula (B).USPTO title: Process for the manufacture of pharmaceutically active compounds
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This patent protects compositions and uses of solid dispersions, complexes, salts, and crystalline polymorphs of a specific compound.USPTO title: Compositions and uses thereof
Sources
- FDA Orange Book — patents listed against Zelboraf (NDA filed 2011)
- Zelboraf drug profile — full patent estate, indications, clinical trials, pricing
- Hoffmann La Roche patent portfolio
- Patent cliff 2026 — 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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