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OmniRx › Tools › Generic competition check › Diclofenac Sodium

Generic competition · all medicines · read 12 November 2026

Is there a generic of Diclofenac Sodium, and who makes it?

Diclofenac Sodium appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 29 generic makers listed as marketed across them. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came between 3.9 and 16.8 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Diclofenac Sodium6 dosage-form groups in the Orange Book
29generic makers listed
  1. Diclofenac Sodium appears in 6 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 29 generic makers listed as marketed across them.
  2. 1 group has a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came between 3.9 and 16.8 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Tablet, Delayed Release, Oral

Four or more generic makers listed

Every brand product here is listed as discontinued. 6 generic makers with 16 generic products listed as marketed; the first generic approval is dated 29 June 1995.

198519901995200020052010201520202025203006brand 1988Actavis Elizabeth Llc, first approval 26 March 1996Carlsbad Technology Inc, first approval 13 November 1998Aurobindo Pharma Usa Inc, first approval 12 February 2002Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd, first approval 8 June 2007Rubicon Research Ltd, first approval 11 May 2023Umedica Laboratories Private Ltd, first approval 5 November 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Elizabeth Llc26 March 19962
Carlsbad Technology Inc13 November 19983
Aurobindo Pharma Usa Inc12 February 20022
Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd8 June 20073
Rubicon Research Ltd11 May 20233
Umedica Laboratories Private Ltd5 November 20253

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Topical

Four or more generic makers listed

Every brand product here is listed as discontinued. 11 generic makers with 14 generic products listed as marketed; the first generic approval is dated 27 May 2014.

200520102015202020252030011brand 2009Watson Laboratories Inc, first approval 24 November 2014Sun Pharma Canada Inc, first approval 26 November 2014Lupin Ltd, first approval 20 August 2015Novel Laboratories Inc, first approval 9 December 2015Amneal Pharmaceuticals Llc, first approval 2 September 2016Zydus Lifesciences Ltd, first approval 17 April 2018Epic Pharma Llc, first approval 28 January 2021Apotex Inc, first approval 6 May 2022Alembic Pharmaceuticals Ltd, first approval 29 November 2022Aurolife Pharma Llc, first approval 3 February 2023Encube Ethicals Private Ltd, first approval 9 April 2025data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Watson Laboratories Inc24 November 20141
Sun Pharma Canada Inc26 November 20142
Lupin Ltd20 August 20152
Novel Laboratories Inc9 December 20151
Amneal Pharmaceuticals Llc2 September 20162
Zydus Lifesciences Ltd17 April 20181
Epic Pharma Llc28 January 20211
Apotex Inc6 May 20221
Alembic Pharmaceuticals Ltd29 November 20221
Aurolife Pharma Llc3 February 20231
Encube Ethicals Private Ltd9 April 20251

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Gel, Topical

Four or more generic makers listed

Brand listed as marketed: Voltaren Arthritis Pain. 10 generic makers with 10 generic products listed as marketed; the first generic approval is dated 28 October 2013.

2000200520102015202020252030010brand 2000Actavis Mid Atlantic Llc, first approval 2 December 2015Amneal Pharmaceuticals, first approval 18 March 2016Sun Pharma Canada Inc, first approval 28 April 2016Glenmark Pharmaceuticals Ltd, first approval 13 September 2016Padagis Israel Pharmaceuticals Ltd, first approval 27 July 2018Cipla Ltd, first approval 3 August 2018Aurolife Pharma Llc, first approval 6 May 2019Perrigo Pharma International Dac, first approval 16 May 2019Encube Ethicals Private Ltd, first approval 27 January 2020Alembic Pharmaceuticals Ltd, first approval 27 July 2022data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Actavis Mid Atlantic Llc2 December 20151
Amneal Pharmaceuticals18 March 20161
Sun Pharma Canada Inc28 April 20161
Glenmark Pharmaceuticals Ltd13 September 20161
Padagis Israel Pharmaceuticals Ltd27 July 20181
Cipla Ltd3 August 20181
Aurolife Pharma Llc6 May 20191
Perrigo Pharma International Dac16 May 20191
Encube Ethicals Private Ltd27 January 20201
Alembic Pharmaceuticals Ltd27 July 20221

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution/Drops, Ophthalmic

Four or more generic makers listed

Every brand product here is listed as discontinued. 5 generic makers with 5 generic products listed as marketed; the first generic approval is dated 28 December 2007.

19901995200020052010201520202025203005brand 1991Bausch And Lomb Inc, first approval 28 December 2007Rising Pharma Holdings Inc, first approval 28 December 2007Sandoz Inc, first approval 6 February 2008Rubicon Research Ltd, first approval 13 November 2008Altaire Pharmaceuticals Inc, first approval 16 November 2015data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Bausch And Lomb Inc28 December 20071
Rising Pharma Holdings Inc28 December 20071
Sandoz Inc6 February 20081
Rubicon Research Ltd13 November 20081
Altaire Pharmaceuticals Inc16 November 20151

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Tablet, Extended Release, Oral

Four or more generic makers listed

Every brand product here is listed as discontinued. 4 generic makers with 4 generic products listed as marketed; the first generic approval is dated 11 February 2000.

1995200020052010201520202025203004brand 1996Valeant Pharmaceuticals North America, first approval 11 February 2000Aurobindo Pharma Usa Inc, first approval 13 December 2001Dexcel Ltd, first approval 6 November 2002Ingenus Pharmaceuticals Llc, first approval 23 September 2022data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Valeant Pharmaceuticals North America11 February 20001
Aurobindo Pharma Usa Inc13 December 20011
Dexcel Ltd6 November 20021
Ingenus Pharmaceuticals Llc23 September 20221

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Intravenous

Brand listed, no generic listed as marketed

Brand listed as marketed: Zueino. No generic is listed as marketed (1 generic product listed as discontinued).

2010201520202025203001brand 2014data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.