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Celebrex generic
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)
| Generic | Manufacturer | Phase | First approval | Country |
|---|---|---|---|---|
| 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)
- —
10722456· Formulation · US - —
10799517· Formulation · US - —
9949990· Formulation · US - —
9795620· Formulation · US - —
9572819· Formulation · US - —
10376527· 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
- Celebrex 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