VARENICLINE TARTRATE generics — when can they launch?
VARENICLINE TARTRATE (VARENICLINE TARTRATE) · · 10 active US patents · 0 expired
Where VARENICLINE TARTRATE sits in the generic timeline
Long-dated protection: earliest active US patent for VARENICLINE TARTRATE extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 8 patents
- Formulation — 2 patents
FDA U-codes carved out by VARENICLINE TARTRATE 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-1900 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the VARENICLINE TARTRATE drug page →
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This patent protects methods and pharmaceutical formulations for treating dry eye disease.USPTO title: Dry eye treatments
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This patent protects methods and pharmaceutical formulations for treating dry eye disease using varenicline.USPTO title: Compositions and use of varenicline for treating dry eye
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This patent protects pharmaceutical formulations for treating ocular conditions.USPTO title: Pharmaceutical formulations for treating ocular conditions
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This patent protects methods and pharmaceutical formulations for treating dry eye disease using varenicline.USPTO title: Compositions and use of varenicline for treating dry eye
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This patent protects methods and pharmaceutical formulations for treating dry eye disease using varenicline.USPTO title: Compositions and use of varenicline for treating dry eye
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This patent protects methods and pharmaceutical formulations for treating dry eye disease.USPTO title: Methods of increasing lacrimal proteins
Sources
- FDA Orange Book — patents listed against VARENICLINE TARTRATE (NDA filed 2006)
- VARENICLINE TARTRATE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2035 — 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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