Zolinza generics — when can they launch?
Zolinza (VORINOSTAT) · Merck & Co. · 2 active US patents · 1 expired
Where Zolinza sits in the generic timeline
Imminent generic cliff: earliest active US patent for Zolinza expires in 2027 (~1 year 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 — 1 patent
- Method of Use — 1 patent
FDA U-codes carved out by Zolinza 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-892 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Zolinza drug page →
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This patent protects polymorphs of suberoylanilide hydroxamic acid, a potent histone deacetylase inhibitor.USPTO title: Polymorphs of suberoylanilide hydroxamic acid
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This patent protects formulations of the drug suberoylanilide hydroxamic acid, also known as Zolinza, and methods for producing them.USPTO title: Formulations of suberoylanilide hydroxamic acid and methods for producing same
Sources
- FDA Orange Book — patents listed against Zolinza (NDA filed 2006)
- Zolinza drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. patent portfolio
- 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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