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Diclofenac Sodium Patent Expiration

Diclofenac Sodium is Used for treating or controlling ocular inflammation in the affected eye. It was first introduced by Novartis Pharmaceuticals Corp in its drug Voltaren on Jul 28, 1988. Other drugs containing Diclofenac Sodium are Dyloject, Voltaren-Xr, Solaraze, Diclofenac Sodium, Voltaren Arthritis Pain, Pennsaid. 48 different companies have introduced drugs containing Diclofenac Sodium.


Diclofenac Sodium Patents

Given below is the list of patents protecting Diclofenac Sodium, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Pennsaid US8546450 Treatment of pain with topical diclofenac compounds Aug 09, 2030 Horizon
Pennsaid US8546450 Treatment of pain with topical diclofenac compounds Aug 09, 2030 Nuvo Pharms Inc
Pennsaid US8217078 Treatment of pain with topical diclofenac Jul 10, 2029 Horizon
Pennsaid US8217078 Treatment of pain with topical diclofenac Jul 10, 2029 Nuvo Pharms Inc
Pennsaid US8618164 Treatment of pain with topical diclofenac compounds Jul 10, 2029 Horizon
Pennsaid US8618164 Treatment of pain with topical diclofenac compounds Jul 10, 2029 Nuvo Pharms Inc
Pennsaid US8741956 Treatment of pain with topical diclofenac Jul 10, 2029 Horizon
Pennsaid US8741956 Treatment of pain with topical diclofenac Jul 10, 2029 Nuvo Pharms Inc
Pennsaid US9370501 Treatment of pain with topical diclofenac Jul 10, 2029 Horizon
Pennsaid US9375412 Treatment of pain with topical diclofenac Jul 10, 2029 Horizon
Pennsaid US9415029 Treatment of pain with topical diclofenac Jul 10, 2029 Horizon
Pennsaid US8252838 Diclofenac topical formulation Apr 21, 2028 Horizon
Pennsaid US8563613 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US8871809 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9066913 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9101591 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9132110 Treatment of pain with topical diclofenac Oct 17, 2027 Horizon
Pennsaid US9168304 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9168305 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9220784 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9339551 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9339552 Diclofenac topical formulation Oct 17, 2027 Horizon
Pennsaid US9539335 Diclofenac topical formulation Oct 17, 2027 Horizon
Dyloject US8946292 Formulations of low dose diclofenac and beta-cyclodextrin Mar 22, 2027 Javelin Pharms Inc
Dyloject US6407079 Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation Jun 18, 2019

(Expired)

 Javelin Pharms Inc
Solaraze US5792753 Compositions comprising hyaluronic acid and prostaglandin-synthesis-inhibiting drugs Aug 11, 2015

(Expired)

 Fougera Pharms
Solaraze US5914322 Treatment of disease and conditions Aug 11, 2015

(Expired)

 Fougera Pharms
Solaraze US5985850 Compositions comprising hyaluronic acid and drugs Aug 11, 2015

(Expired)

 Fougera Pharms
Diclofenac Sodium US5603929 Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds Nov 16, 2014

(Expired)

 Falcon Pharms
Diclofenac Sodium US5653972 Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds Nov 16, 2014

(Expired)

 Falcon Pharms
Solaraze US5639738 Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs Jun 17, 2014

(Expired)

 Fougera Pharms
Solaraze US5852002 Treatment of conditions and disease Jun 17, 2014

(Expired)

 Fougera Pharms
Solaraze US5929048 Treatment of conditions and disease Jun 17, 2014

(Expired)

 Fougera Pharms



Diclofenac Sodium's Family Patents

Family Patents

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Diclofenac Sodium Generic API Manufacturers

Several generic applications have been filed for Diclofenac Sodium. The first generic version for Diclofenac Sodium was by Roxane Laboratories Inc and was approved on Jun 29, 1995. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Apr 9, 2025.

Given below is the list of companies who have filed for Diclofenac Sodium generic, along with the locations of their manufacturing plants worldwide.


1. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

tablet, delayed release Prescription ORAL AB Mar 26, 1996
50MG

tablet, delayed release Prescription ORAL AB Mar 26, 1996
100MG

tablet, extended release Discontinued ORAL N/A Jan 7, 2002


Manufacturing Plant Locations
New

Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.

Country City Firm Name
United States
Elizabeth Actavis Elizabeth LLC, A Company of Teva





2. ACTAVIS LABS UT INC

Actavis Laboratories Ut Inc Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

solution Prescription TOPICAL AT May 15, 2017





3. ACTAVIS MID ATLANTIC

Actavis Mid Atlantic Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3%

gel Prescription TOPICAL AB Dec 2, 2015





4. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3%

gel Prescription TOPICAL BX Jul 27, 2022
2%

solution Prescription TOPICAL AB Nov 29, 2022


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panelav Alembic Pharmaceuticals Limited





5. ALTAIRE PHARMS INC

Altaire Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Altaire Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

solution/drops Prescription OPHTHALMIC AT Nov 16, 2015





6. AMNEAL

Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3%

gel Prescription TOPICAL AB Oct 28, 2013
2%

solution Prescription TOPICAL AB Aug 18, 2022


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Glasgow Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Piscataway Amneal Pharmaceuticals, LLC
East Hanover Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.





7. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Over the counter TOPICAL N/A Mar 18, 2016
1.5%

solution Prescription TOPICAL AT Sep 2, 2016





8. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Discontinued TOPICAL N/A May 27, 2014
2%

solution Prescription TOPICAL AB May 6, 2022


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





9. AUROBINDO PHARMA USA

Aurobindo Pharma Usa Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

tablet, extended release Discontinued ORAL N/A Dec 13, 2001
50MG

tablet, delayed release Discontinued ORAL N/A Feb 12, 2002
75MG

tablet, delayed release Discontinued ORAL N/A Feb 12, 2002


Manufacturing Plant Locations
New

Aurobindo Pharma Usa's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Usa as present at those locations.

Country City Firm Name
United States
East Windsor Aurobindo Pharma USA Inc





10. AUROLIFE PHARMA LLC

Aurolife Pharma Llc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Aurolife Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Over the counter TOPICAL N/A May 6, 2019
2%

solution Prescription TOPICAL AB Feb 3, 2023


Manufacturing Plant Locations
New

Aurolife Pharma Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Aurolife Pharma Llc as present at those locations.

Country City Firm Name
United States
Durham Aurolife Pharma LLC





11. BAUSCH AND LOMB

Bausch And Lomb Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

(reference standard)

solution/drops Prescription OPHTHALMIC AT Dec 28, 2007


Manufacturing Plant Locations
New

Bausch And Lomb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bausch And Lomb as present at those locations.

Country City Firm Name
United States
Bridgewater Bausch and Lomb, Inc
Rancho Cucamonga Bausch and Lomb, Incorporated
Irvine Bausch and Lomb, Incorporated





12. CARLSBAD

Carlsbad Technology Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Carlsbad.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

tablet, delayed release Prescription ORAL AB Nov 13, 1998
50MG

tablet, delayed release Prescription ORAL AB Nov 13, 1998
25MG

tablet, delayed release Prescription ORAL AB Nov 13, 1998


Manufacturing Plant Locations
New

Carlsbad's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Carlsbad as present at those locations.

Country City Firm Name
United States
Carlsbad Carlsbad Technology, Inc
Carlsbad Carlsbad International Export Inc
Carlsbad Carlsbad Alkaline Water





13. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Chartwell Rx.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG

tablet, delayed release Discontinued ORAL N/A Sep 28, 1995
50MG

tablet, delayed release Discontinued ORAL N/A Sep 28, 1995
75MG

tablet, delayed release Discontinued ORAL N/A Nov 30, 1995





14. CIPLA

Cipla Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Over the counter TOPICAL N/A Aug 3, 2018


Manufacturing Plant Locations
New

Cipla's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Cipla as present at those locations.

Country City Firm Name
India
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Bangalore Cipla Ltd.
Raigad Cipla Limited
Mumbai Cipla Limited
Bengaluru Cipla Limited
Vasco Da Gama Cipla Limited
Pithampur, District Dhar Cipla Limited





15. DEXCEL LTD

Dexcel Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Dexcel Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

(reference standard)

tablet, extended release Prescription ORAL AB Nov 6, 2002





16. ENCUBE

Encube Ethicals Private Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Over the counter TOPICAL N/A Jan 27, 2020
2%

solution Prescription TOPICAL AB Apr 9, 2025


Manufacturing Plant Locations
New

Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.

Country City Firm Name
India
Andheri East, Mumbai Encube Ethicals Private Ltd
Ponda Encube Ethicals Pvt. Ltd.





17. EPIC PHARMA LLC

Epic Pharma Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Prescription TOPICAL AT Jan 28, 2021





18. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3%

gel Prescription TOPICAL AB Sep 13, 2016





19. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Discontinued TOPICAL N/A Nov 21, 2018


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





20. LUPIN LTD

Lupin Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Prescription TOPICAL AT Aug 20, 2015


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





21. LUPIN PHARMS

Lupin Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Lupin Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2%

(reference standard)

solution Prescription TOPICAL AB Sep 20, 2022





22. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

tablet, delayed release Discontinued ORAL N/A Feb 26, 1999
75MG

tablet, delayed release Discontinued ORAL N/A Feb 26, 1999


Manufacturing Plant Locations
New

Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bengaluru Micro Labs Limited
Bangalore Micro Labs Limited





23. NOVEL LABS INC

Novel Laboratories Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Novel Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Prescription TOPICAL AT Dec 9, 2015





24. PADAGIS ISRAEL

Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Padagis Israel.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3%

gel Prescription TOPICAL AB Jul 27, 2018


Manufacturing Plant Locations
New

Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.

Country City Firm Name
Israel
Yerucham Padagis Israel Pharmaceuticals Ltd.





25. PAI HOLDINGS PHARM

Pai Holdings Llc Dba Pharmaceutical Associates Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Pai Holdings Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Discontinued TOPICAL N/A Jul 8, 2015





26. PERRIGO PHARMA INTL

Perrigo Pharma International Dac has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Perrigo Pharma Intl.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1%

gel Over the counter TOPICAL N/A May 16, 2019





27. PLIVA

Pliva Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Pliva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

tablet, delayed release Discontinued ORAL N/A Jul 29, 1999
75MG

tablet, delayed release Discontinued ORAL N/A Jul 29, 1999


Manufacturing Plant Locations
New

Pliva's manufacturing plants are situated in 3 countries - Croatia, United States, Czech Republic. Given below are the details of these plant locations as well as the firm names of Pliva as present at those locations.

Country City Firm Name
Croatia
Zagreb PLIVA Hrvatska d.o.o.
Brdovec Pliva Hrvatska d.o.o.
United States
East Hanover Pliva, Inc.
Czech Republic
Brno PLIVA-Lachema a.s.





28. RICONPHARMA LLC

Riconpharma Llc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Riconpharma Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

tablet, extended release Prescription ORAL AB Sep 23, 2022


Manufacturing Plant Locations
New

Riconpharma Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Riconpharma Llc as present at those locations.

Country City Firm Name
United States
Denville RiconPharma LLC





29. RISING

Rising Pharma Holding Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

solution/drops Prescription OPHTHALMIC AT Dec 28, 2007
1.5%

solution Discontinued TOPICAL N/A Aug 7, 2017
37.5MG/ML (37.5MG/ML)

solution Discontinued INTRAVENOUS N/A Jun 18, 2019


Manufacturing Plant Locations
New

Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.

Country City Firm Name
United States
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





30. ROXANE

Roxane Laboratories Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Roxane.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

tablet, delayed release Discontinued ORAL N/A Jun 29, 1995
75MG

tablet, delayed release Discontinued ORAL N/A Jun 29, 1995
25MG

tablet, delayed release Discontinued ORAL N/A Jun 29, 1995





31. RUBICON

Rubicon Research Private Ltd has filed for 4 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

solution/drops Prescription OPHTHALMIC AT Nov 13, 2008
25MG

tablet, delayed release Prescription ORAL AB May 11, 2023
50MG

tablet, delayed release Prescription ORAL AB May 11, 2023
75MG

tablet, delayed release Prescription ORAL AB May 11, 2023


Manufacturing Plant Locations
New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country City Firm Name
United States
Geismar Rubicon, LLC
Indianapolis Rubicon Foods LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





32. SANDOZ

Sandoz Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

solution/drops Prescription OPHTHALMIC AT Feb 6, 2008


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





33. SCIEGEN PHARMS INC

Sciegen Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.1%

solution/drops Discontinued OPHTHALMIC N/A Apr 17, 2008





34. TARO

Taro Pharmaceuticals Inc has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Taro.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

(reference standard)

solution Prescription TOPICAL AT Nov 26, 2014
3%

(reference standard)

gel Prescription TOPICAL AB Apr 28, 2016
2%

solution Prescription TOPICAL AB Sep 29, 2022


Manufacturing Plant Locations
New

Taro's manufacturing plants are situated in 3 countries - United States, Israel, Canada. Given below are the details of these plant locations as well as the firm names of Taro as present at those locations.

Country City Firm Name
United States
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Honolulu Taro Delight, LLC
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





35. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

tablet, delayed release Discontinued ORAL N/A Aug 15, 1996
50MG

tablet, delayed release Discontinued ORAL N/A Mar 30, 1999


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Fort Dodge TEVA Animal Health Inc
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
Horsham Teva Branded Pharmaceutical Products R&D
India
Bhind Teva API India Ltd- Malanpur
Gajraula, Amroha Teva API India Private Ltd.
Canada
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Stouffville Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





36. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

tablet, delayed release Discontinued ORAL N/A Jun 25, 1997
25MG

tablet, delayed release Discontinued ORAL N/A Jun 25, 1997
50MG

tablet, delayed release Discontinued ORAL N/A Jun 25, 1997





37. TWI PHARMS

Twi Pharmaceuticals Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Twi Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Discontinued TOPICAL N/A Nov 24, 2014





38. UNIQUE

Unique Pharmaceutical Laboratories A Div Of Jb Chemicals And Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Unique.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG

(reference standard)

tablet, delayed release Prescription ORAL AB Jun 8, 2007
25MG

(reference standard)

tablet, delayed release Prescription ORAL AB Dec 1, 2010
50MG

(reference standard)

tablet, delayed release Prescription ORAL AB Dec 1, 2010


Manufacturing Plant Locations
New

Unique's manufacturing plants are situated in 5 countries - United States, India, Canada, Portugal, Taiwan. Given below are the details of these plant locations as well as the firm names of Unique as present at those locations.

Country City Firm Name
United States
Cypress Unique Distributors, Inc. dba Florentino Ice Cream
Gold Canyon Unique Ingredients LLC.
Cumberland Unique Soy Products International, LLC
Landing Unique Encapsulation Technology, LLC
Ottawa Uniquely Emu Products, Inc.
Everett Unique sushi
Chatsworth Unique Laboratories, Inc.
Bridgeport Unique Instruments, Inc.
Norman Unique Confections LLC
Concord Unique Molded Foam Technologies, Inc.
Brownsville Unique Candies Llc
Nashville Unique Surgical Inc
Richmond Hill Unique Importer & Distributor Inc.
Bisbee Unique Coffee, LLC
Garner Unique Food Company
India
Bharuch Unique Pharmaceutical Laboratories (A Division of J. B. Chemicals & Pharmaceuticals Ltd)
Sonepat Unique Fragrances
Ankleshwar Unique Chemicals
Navi Mumbai Unique Chemicals
Surat Unique Hospital- Multispecialty & Research Institute
New Delhi Unique Fragrances
Canada
Cambridge Unique Global Product and Distribution Inc.
Portugal
Velas Uniqueijo - Uniao de Cooperativas Agricolas de Lacticinios de Sao Jorge, UCRL
Taiwan
Toucheng Township Unique Safety Equipment Co., Ltd





39. VPNA

Valeant Pharmaceuticals North America has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Vpna.

Strength Dosage Form Availability Application Pathway TE code Launch Date
100MG

tablet, extended release Prescription ORAL AB Feb 11, 2000





40. WATSON LABS INC

Watson Laboratories Inc has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Prescription TOPICAL AT Nov 24, 2014





41. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 1 generic for Diclofenac Sodium. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5%

solution Prescription TOPICAL AT Apr 17, 2018


Manufacturing Plant Locations
New

Zydus Lifesciences's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Zydus Lifesciences as present at those locations.

Country City Firm Name
India
District Solan Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Matoda Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited