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Lyrica generic
About Lyrica
Lyrica (Pregabalin) — originally marketed by Pfizer Inc.. Class: Anticonvulsant, analgesic.
Approved generic versions (11)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| Pregabalin and dexmedetomidine | Wonkwang University Hospital | marketed | ||
| Pregabalin and Oxcarbazepine | Ju Seok Ryu | marketed | ||
| Pregabalin 300mg | University of Missouri-Columbia | marketed | ||
| Pregabalin; Dexamethasone | Glostrup University Hospital, Copenhagen | marketed | ||
| Pregabalin 25 MG | Ajou University School of Medicine | marketed | ||
| Pregabalin capsule | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | marketed | ||
| pregabalin and celecoxib | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | marketed | ||
| pregabalin 450 mg | Viatris Specialty LLC | marketed | ||
| Pregabalin-Lyrica | Rush University Medical Center | marketed | ||
| Pregabalin 50mg | Hospital for Special Surgery, New York | marketed | ||
| pregabalin capsules | AstraZeneca | marketed |
Originator patent timeline
Active patents (6)
- —
9144559*PED· Compound · US - —
10022447*PED· Compound · US - —
8945620*PED· Compound · US - —
10022447· Method of Use · US - —
8945620· Formulation · US - —
9144559· Formulation · US
Expired patents (0)
How small-molecule generic approval works
Generic versions of small-molecule drugs are approved by the FDA via the Abbreviated New Drug Application (ANDA) pathway under the Hatch-Waxman Act of 1984. Sponsors must demonstrate bioequivalence (pharmacokinetic equivalence within tight bounds) and identical chemical composition — no clinical trials in patients are required. Approval typically takes 18-24 months.
This is different from biosimilars for biologic drugs, which use the more complex 351(k) BLA pathway and typically achieve smaller (15-35%) discounts vs the originator. Small-molecule generics typically launch at 60-80% discount, dropping to 85-95% within 2 years.
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Related
- Lyrica full drug profile
- Biosimilar tracker (for biologic drugs)
- Patent cliff tracker
- Biosimilar vs generic — what's the difference?
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing