FDA Orange Book · active-ingredient family
Celecoxib
Celecoxib is approved as 3 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:VYSCOXA · NDA 211759
3
Brand (NDA)
26
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution, suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VYSCOXARLD | CARWIN PHARM ASSOC | NDA 211759 | — | Jul 29, 2025 | |
| ELYXYBRLD | SCILEX PHARMS | NDA 212157 | — | May 05, 2020 | |
| CELEBREXRLD×4 | UPJOHN | NDA 020998 | AB | Dec 15, 2006 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CELECOXIB×4 | ZYDUS PHARMS | ANDA 205938 | — | Jul 14, 2025 | |
| CELECOXIB×3 | STRIDES PHARMA | ANDA 213127 | — | Apr 29, 2025 | |
| CELECOXIB×3 | YABAO PHARM | ANDA 212564 | — | Apr 10, 2023 | |
| CELECOXIB×4 | UNICHEM | ANDA 213301 | — | Jan 12, 2021 | |
| CELECOXIB×2 | PANGEA | ANDA 212925 | — | Dec 09, 2020 | |
| CELECOXIB×4 | SCIEGEN PHARMS | ANDA 205129 | AB | Dec 03, 2020 | |
| CELECOXIB | NANJING | ANDA 213598 | AB | May 13, 2020 | |
| CELECOXIB×4 | YILING | ANDA 211412 | AB | Mar 06, 2020 | |
| CELECOXIB×4 | TIANJIN TIANYAO | ANDA 207872 | AB | Feb 25, 2020 | |
| CELECOXIB×4 | UMEDICA | ANDA 210628 | AB | Nov 27, 2019 | |
| CELECOXIB×4 | CADILA PHARMS LTD | ANDA 208701 | AB | Nov 14, 2019 | |
| CELECOXIB×4 | QINGDAO BAHEAL PHARM | ANDA 208856 | AB | Aug 07, 2019 | |
| CELECOXIB×4 | AMNEAL PHARMS | ANDA 208833 | — | May 31, 2018 | |
| CELECOXIB×4 | MICRO LABS | ANDA 204776 | AB | Apr 30, 2018 | |
| CELECOXIB×3 | CSPC OUYI | ANDA 210071 | AB | Jan 23, 2018 | |
| CELECOXIB×4 | JUBILANT GENERICS | ANDA 207061 | — | Apr 04, 2017 | |
| CELECOXIB×4 | MACLEODS PHARMS LTD | ANDA 204590 | AB | Mar 16, 2016 | |
| CELECOXIB×4 | AUROBINDO PHARMA | ANDA 206827 | AB | Feb 01, 2016 | |
| CELECOXIB×4 | TORRENT | ANDA 207677 | AB | Dec 23, 2015 | |
| CELECOXIB×4 | CIPLA | ANDA 207446 | AB | Sep 23, 2015 | |
| CELECOXIB×4 | ALEMBIC | ANDA 204519 | AB | Aug 21, 2015 | |
| CELECOXIB×3 | APOTEX | ANDA 204197 | AB | Jun 02, 2015 | |
| CELECOXIB×4 | WATSON LABS INC | ANDA 200562 | AB | Feb 11, 2015 | |
| CELECOXIB×4 | LUPIN | ANDA 202240 | AB | Oct 29, 2014 | |
| CELECOXIB×4 | PHARMOBEDIENT | ANDA 078857 | — | May 30, 2014 | |
| CELECOXIB×4 | TEVA | ANDA 076898 | AB | May 30, 2014 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10722456 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
| 10799517 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
| 9949990 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
| 9795620 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
| 9572819 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
| 10376527 | May 27, 2036 | in 10 yr 1 mo | ProductU-2718 |
Celecoxib — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
