FDA Orange Book · active-ingredient family
Diclofenac potassium
Diclofenac potassium is approved as 3 brand and 19 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAMBIA · NDA 022165
3
Brand (NDA)
19
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, for solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAMBIARLD | ASSERTIO SPECLTY | NDA 022165 | AB | Jun 17, 2009 | |
| ZIPSORRLD | ASSERTIO SPECLTY | NDA 022202 | AB | Jun 16, 2009 | |
| CATAFLAMRLD×2 | NOVARTIS | NDA 020142 | — | Nov 24, 1993 |
Generic (ANDA) products (19)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DICLOFENAC POTASSIUM | UMEDICA | ANDA 217010 | AB | Aug 29, 2025 | |
| DICLOFENAC POTASSIUM×2 | UMEDICA | ANDA 215750 | AB | Jun 30, 2025 | |
| DICLOFENAC POTASSIUM | TORRENT | ANDA 215891 | AB | Jan 22, 2025 | |
| DICLOFENAC POTASSIUM | TARO | ANDA 218011 | AB | Jun 14, 2024 | |
| DICLOFENAC POTASSIUM×2 | SENORES PHARMS | ANDA 215787 | AB | Nov 09, 2023 | |
| DICLOFENAC POTASSIUM | ALKEM LABS LTD | ANDA 216635 | AB | Jul 20, 2022 | |
| DICLOFENAC POTASSIUM | ANNORA PHARMA | ANDA 215375 | AB | Mar 04, 2022 | |
| DICLOFENAC POTASSIUM | AUROBINDO PHARMA LTD | ANDA 213875 | AB | Oct 19, 2021 | |
| DICLOFENAC POTASSIUM | INGENUS PHARMS LLC | ANDA 215585 | AB | Oct 08, 2021 | |
| DICLOFENAC POTASSIUM×2 | RUBICON RESEARCH | ANDA 075229 | AB | Sep 16, 2021 | |
| CATAFLAM×2 | AMICI PHARMA | ANDA 076561 | AB | Jul 21, 2021 | |
| DICLOFENAC POTASSIUM | ONESOURCE SPECIALTY | ANDA 210078 | AB | Dec 03, 2019 | |
| DICLOFENAC POTASSIUM | PH HEALTH | ANDA 202964 | AB | May 02, 2016 | |
| DICLOFENAC POTASSIUM | BIONPHARMA | ANDA 204648 | AB | Feb 23, 2016 | |
| DICLOFENAC POTASSIUM | SUN PHARM INDUSTRIES | ANDA 075470 | — | Feb 21, 2002 | |
| DICLOFENAC POTASSIUM | CHARTWELL RX | ANDA 075582 | — | Feb 23, 2001 | |
| DICLOFENAC POTASSIUM | RK PHARMA | ANDA 075463 | AB | Jul 26, 1999 | |
| DICLOFENAC POTASSIUM | WATSON LABS TEVA | ANDA 075152 | — | Nov 27, 1998 | |
| DICLOFENAC POTASSIUM | TEVA | ANDA 075219 | AB | Aug 06, 1998 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8097651 | Jun 16, 2026 | 3 d ago | SubstanceProductU-436 |
| 7759394 | Jun 16, 2026 | 3 d ago | SubstanceProductU-436 |
| 8927604 | Jun 16, 2026 | 3 d ago | U-436 |
| 9827197 | Jun 16, 2026 | 3 d ago | Product |
| 7884095 | Feb 24, 2029 | in 2 yr 9 mo | U-1111 |
| 8110606 | Feb 24, 2029 | in 2 yr 9 mo | U-980 |
| 7662858 | Feb 24, 2029 | in 2 yr 9 mo | U-1035 |
| 7939518 | Feb 24, 2029 | in 2 yr 9 mo | U-980 |
| 8623920 | Feb 24, 2029 | in 2 yr 9 mo | U-1482 |
| 9561200 | Feb 24, 2029 | in 2 yr 9 mo | U-1482 |
Diclofenac potassium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
