FDA Orange Book · active-ingredient family
Diclofenac potassium
Diclofenac potassium: 3 brands, 19 generics; first approved Nov 24, 1993; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 19 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
19
Listed patents
10
Next patent expiry
Jun 16, 2026
2 mo ago
Brand (NDA) products
Originator applications
- COSETTENDA 0221652009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - COSETTENDA 0222022009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - CATAFLAMRLDNOVARTISNDA 02014219932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG TABLET ORAL Discontinued — 50MG TABLET ORAL Discontinued —
Generic (ANDA) products (19)
Abbreviated applications
- DICLOFENAC POTASSIUMUMEDICAANDA 2170102025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMUMEDICAANDA 21575020252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - DICLOFENAC POTASSIUMTORRENTANDA 2158912025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMTAROANDA 2180112024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMSENORES PHARMSANDA 21578720232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - DICLOFENAC POTASSIUMALKEM LABS LTDANDA 2166352022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMANNORA PHARMAANDA 2153752022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMAUROBINDO PHARMA LTDANDA 2138752021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - DICLOFENAC POTASSIUMINGENUS PHARMS LLCANDA 2155852021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - DICLOFENAC POTASSIUMRUBICON RESEARCHANDA 07522920212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - AMICI PHARMAANDA 07656120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB 25MG TABLET ORAL Rx AB - DICLOFENAC POTASSIUMONESOURCE SPECIALTYANDA 2100782019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - DICLOFENAC POTASSIUMPH HEALTHANDA 2029642016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG FOR SOLUTION ORAL Rx AB - DICLOFENAC POTASSIUMBIONPHARMAANDA 2046482016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG CAPSULE ORAL Rx AB - DICLOFENAC POTASSIUMSUN PHARM INDUSTRIESANDA 0754702002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DICLOFENAC POTASSIUMCHARTWELL RXANDA 0755822001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DICLOFENAC POTASSIUMRISINGANDA 0754631999
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB - DICLOFENAC POTASSIUMWATSON LABS TEVAANDA 0751521998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Discontinued — - DICLOFENAC POTASSIUMTEVAANDA 0752191998
Approved strengths under this FDA application. Strength Dosage form Route Status TE 50MG TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8097651 | 2 mo ago | SubstanceProductU-436 | |
| 7759394 | 2 mo ago | SubstanceProductU-436 | |
| 8927604 | 2 mo ago | U-436 | |
| 9827197 | 2 mo ago | Product | |
| 7884095 | in 2 yr 6 mo | U-1111 | |
| 8110606 | in 2 yr 6 mo | U-980 | |
| 7662858 | in 2 yr 6 mo | U-1035 | |
| 7939518 | in 2 yr 6 mo | U-980 | |
| 8623920 | in 2 yr 6 mo | U-1482 | |
| 9561200 | in 2 yr 6 mo | U-1482 |
Approval history
FDA approval span
First approval
33 yr 3 mo ago
Most recent approval
1 yr ago
Approvals span 1993–2025 across 22 FDA applications.
Brand (NDA) 314%
Generic (ANDA) 1986%
Diclofenac potassium: 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.
