Nevanac generics — when can they launch?
Nevanac (NEPAFENAC) · Harrow Health · 3 active US patents · 0 expired
Where Nevanac sits in the generic timeline
Imminent generic cliff: earliest active US patent for Nevanac 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.
- Formulation — 2 patents
- Method of Use — 1 patent
FDA U-codes carved out by Nevanac 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-1095 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Nevanac drug page →
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This patent protects topical nepafenac formulations, especially suitable for topical ophthalmic administration.USPTO title: Topical nepafenac formulations
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This patent protects a suspension composition containing a carboxyvinyl polymer, a galactomannan, a borate compound, and a sparingly soluble particulate compound, such as nepafenac.USPTO title: Carboxylvinyl polymer-containing nanoparticle suspensions
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This patent protects a suspension composition containing a carboxyvinyl polymer, a galactomannan, a borate compound, and a sparingly soluble particulate compound, such as nepafenac.USPTO title: Carboxyvinyl polymer-containing nanoparticle suspensions
Sources
- FDA Orange Book — patents listed against Nevanac (NDA filed 2005)
- Nevanac drug profile — full patent estate, indications, clinical trials, pricing
- Harrow Health 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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