Viagra generics — when can they launch?
Viagra (Sildenafil Citrate) · Pfizer Inc. · 9 active US patents · 0 expired
Where Viagra sits in the generic timeline
Long-dated protection: earliest active US patent for Viagra extends to 2033 (~8 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 — 5 patents
- Formulation — 4 patents
FDA U-codes carved out by Viagra 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-3582 | (no description) |
Sample patent estate
Showing 6 of 9 active US patents. View full estate on the Viagra drug page →
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This patent protects an orodispersible film free from hydrocolloids for therapeutic or food use, made with specific ingredients in certain weight percentages.USPTO title: Orodispersible films having quick dissolution times for therapeutic and food use
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This patent protects an orodispersible film free from hydrocolloids for therapeutic or food use, made with specific ingredients in certain weight percentages.USPTO title: Orodispersible films having quick dissolution times for therapeutic and food use
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This patent protects an orodispersible film free from hydrocolloids for therapeutic or food use, made with specific ingredients in certain weight percentages.USPTO title: Orodispersible films having quick dissolution times for therapeutic and food use
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This patent protects an orodispersible film free from hydrocolloids for therapeutic or food use, made with specific ingredients in certain weight percentages.USPTO title: Orodispersible films having quick dissolution times for therapeutic and food use
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This patent protects liquid oral formulations of sildenafil, a PDE V inhibitor used to treat conditions like pulmonary arterial hypertension and erectile dysfunction.USPTO title: Liquid oral formulations for sildenafil
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This patent protects liquid oral formulations of sildenafil, a PDE V inhibitor used to treat conditions like pulmonary arterial hypertension and erectile dysfunction.USPTO title: Liquid oral formulations for sildenafil
Sources
- FDA Orange Book — patents listed against Viagra (NDA)
- Viagra drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. patent portfolio
- Patent cliff 2033 — 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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