Lyrica generics — when can they launch?
Lyrica (Pregabalin) · Pfizer Inc. · 18 active US patents · 0 expired
Where Lyrica sits in the generic timeline
All listed Orange Book patents for Lyrica have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
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.
- Other — 9 patents
- Method of Use — 6 patents
- Formulation — 3 patents
FDA U-codes carved out by Lyrica 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-2137 | (no description) |
U-2136 | (no description) |
Sample patent estate
Showing 6 of 18 active US patents. View full estate on the Lyrica drug page →
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
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This patent protects a solid pharmaceutical composition containing pregabalin, suitable for once daily oral administration.USPTO title: Solid pharmaceutical compositions containing pregabalin
Sources
- FDA Orange Book — patents listed against Lyrica (NDA)
- Lyrica drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer Inc. patent portfolio
- Patent cliff 2026 — 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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