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Celebrex generic

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

6 approved generics 6 active patents

About Celebrex

Celebrex (celecoxib) — originally marketed by Pfizer Inc. (originally Searle/Pharmacia). Class: Nonsteroidal Anti-inflammatory Drug [EPC]. First approved 1998-12-31.

Approved generic versions (6)

GenericManufacturerPhaseFirst approvalCountry
CELECOXIB marketed 1998-01-01
Celecoxib 400 milligrams Pfizer marketed
Celecoxib 100 mg Charles University, Czech Republic marketed
Celecoxib 200 milligrams Pfizer marketed
Celecoxib capsule Xuhui Central Hospital, Shanghai marketed
Celecoxib (Celebrex) National Eye Institute (NEI) 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