FDA Orange Book · active-ingredient family
Celecoxib
Celecoxib: 3 brands, 26 generics; first approved Dec 31, 1998; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
26
Listed patents
6
Next patent expiry
May 27, 2036
in 9 yr 11 mo
Brand (NDA) products
Originator applications
- CARWIN PHARM ASSOCNDA 2117592025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG/ML SUSPENSION ORAL Rx — - SCILEX PHARMSNDA 2121572020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/ML SOLUTION ORAL Rx — - CELEBREXRLDUPJOHNNDA 02099820064 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB 50MG CAPSULE ORAL Rx AB
Generic (ANDA) products (26)
Abbreviated applications
- CELECOXIBZYDUS PHARMSANDA 20593820254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBSTRIDES PHARMAANDA 21312720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBYABAO PHARMANDA 21256420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBUNICHEMANDA 21330120214 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBPANGEAANDA 21292520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBSCIEGEN PHARMSANDA 20512920204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBNANJINGANDA 2135982020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG CAPSULE ORAL Rx AB - CELECOXIBYILINGANDA 21141220204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBTIANJIN TIANYAOANDA 20787220204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBUMEDICAANDA 21062820194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBCADILA PHARMS LTDANDA 20870120194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBQINGDAO BAHEAL PHARMANDA 20885620194 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBAMNEAL PHARMSANDA 20883320184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBMICRO LABSANDA 20477620184 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBCSPC OUYIANDA 21007120183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - CELECOXIBJUBILANT GENERICSANDA 20706120174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBMACLEODS PHARMS LTDANDA 20459020164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBAUROBINDO PHARMAANDA 20682720164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBTORRENTANDA 20767720154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBCIPLAANDA 20744620154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBALEMBICANDA 20451920154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBAPOTEXANDA 20419720153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB - CELECOXIBWATSON LABS INCANDA 20056220154 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBLUPINANDA 20224020144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB - CELECOXIBALLIEDANDA 07885720144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Discontinued — 100MG CAPSULE ORAL Discontinued — 200MG CAPSULE ORAL Discontinued — 400MG CAPSULE ORAL Discontinued — - CELECOXIBTEVAANDA 07689820144 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG CAPSULE ORAL Rx AB 100MG CAPSULE ORAL Rx AB 200MG CAPSULE ORAL Rx AB 400MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 10722456 | in 9 yr 11 mo | ProductU-2718 | |
| 10799517 | in 9 yr 11 mo | ProductU-2718 | |
| 9949990 | in 9 yr 11 mo | ProductU-2718 | |
| 9795620 | in 9 yr 11 mo | ProductU-2718 | |
| 9572819 | in 9 yr 11 mo | ProductU-2718 | |
| 10376527 | in 9 yr 11 mo | ProductU-2718 |
Approval history
FDA approval span
First approval
28 yr 1 mo ago
Most recent approval
1 yr 1 mo ago
Approvals span 1998–2025 across 29 FDA applications.
Brand (NDA) 310%
Generic (ANDA) 2690%
Celecoxib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
