Jublia generics — when can they launch?
Jublia (EFINACONAZOLE) · Bausch Health · 17 active US patents · 1 expired
Where Jublia sits in the generic timeline
Imminent generic cliff: earliest active US patent for Jublia expires in 2028 (~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.
- Method of Use — 11 patents
- Formulation — 6 patents
FDA U-codes carved out by Jublia 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-1969 | (no description) |
U-2720 | (no description) |
U-281 | (no description) |
U-2721 | (no description) |
Sample patent estate
Showing 6 of 17 active US patents. View full estate on the Jublia drug page →
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This patent protects methods and compositions for treating disorders of the nail and nail bed using a specific type of pharmaceutical composition.USPTO title: Compositions and methods for treating diseases of the nail
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This patent protects methods and compositions for treating disorders of the nail and nail bed using a specific type of pharmaceutical composition.USPTO title: Compositions and methods for treating diseases of the nail
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This patent protects methods and compositions for treating disorders of the nail and nail bed using a specific type of pharmaceutical composition.USPTO title: Compositions and methods for treating diseases of the nail
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This patent protects methods and compositions for treating disorders of the nail and nail bed using a specific type of pharmaceutical composition.USPTO title: Compositions and methods for treating diseases of the nail
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This patent protects methods and compositions for treating disorders of the nail and nail bed using a specific type of pharmaceutical composition.USPTO title: Compositions and methods for treating diseases of the nail
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This patent protects methods and compositions for treating nail and nail bed disorders with a specific type of formulation that has a low surface tension and continuing spreadability.USPTO title: Compositions and methods for treating diseases of the nail
Sources
- FDA Orange Book — patents listed against Jublia (NDA filed 2014)
- Jublia drug profile — full patent estate, indications, clinical trials, pricing
- Bausch Health patent portfolio
- Patent cliff 2028 — 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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