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Lyrica generic

Complete generic competition for Lyrica (Pregabalin): 11 approved generics across manufacturers, 0 filed under FDA review. 6 active patents remain. Sourced from FDA Orange Book + USPTO.

11 approved generics 6 active patents

About Lyrica

Lyrica (Pregabalin) — originally marketed by Pfizer Inc.. Class: Anticonvulsant, analgesic.

Approved generic versions (11)

GenericManufacturerPhaseFirst approvalCountry
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)

Expired patents (0)

No expired patents tracked.

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

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing