Diclofenac Potassium Patent Expiration

Diclofenac Potassium is Used for relief of mild to moderate acute pain as a nonsteroidal anti-inflammatory drug. It was first introduced by Novartis Pharmaceuticals Corp in its drug Cataflam on Nov 24, 1993. Other drugs containing Diclofenac Potassium are Cambia, Zipsor. 19 different companies have introduced drugs containing Diclofenac Potassium.


Diclofenac Potassium Patents

Given below is the list of patents protecting Diclofenac Potassium, 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
Zipsor US7662858 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Zipsor US7884095 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Zipsor US7939518 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Zipsor US8110606 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Zipsor US8623920 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Zipsor US9561200 Method of treating post-surgical acute pain Feb 24, 2029 Assertio
Cambia US7759394 Diclofenac formulations and methods of use Jun 16, 2026 Assertio
Cambia US8097651 Diclofenac formulations and methods of use Jun 16, 2026 Assertio
Cambia US8927604 Diclofenac formulations and methods of use Jun 16, 2026 Assertio
Cambia US9827197 Diclofenac formulations and methods of use Jun 16, 2026 Assertio
Zipsor US6365180 Oral liquid compositions Jul 15, 2019

(Expired)

Assertio
Zipsor US6287594 Oral liquid compositions Jan 15, 2019

(Expired)

Assertio
Cambia US6974595 Pharmaceutical compositions based on Diclofenae May 15, 2017

(Expired)

Assertio
Cambia US7482377 Pharmaceutical compositions and methods of treatment based on diclofenac May 15, 2017

(Expired)

Assertio



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Diclofenac Potassium's patents.

Given below is the list recent legal activities going on the following patents of Diclofenac Potassium.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 07 Aug, 2023 US8110606
Payment of Maintenance Fee, 12th Year, Large Entity 10 Nov, 2022 US7939518
Payment of Maintenance Fee, 12th Year, Large Entity 08 Aug, 2022 US7884095
Payment of Maintenance Fee, 12th Year, Large Entity 16 Aug, 2021 US7662858
Payment of Maintenance Fee, 4th Year, Large Entity 07 Aug, 2020 US9561200
Payment of Maintenance Fee, 8th Year, Large Entity 07 Aug, 2019 US8110606
Payment of Maintenance Fee, 8th Year, Large Entity 12 Nov, 2018 US7939518
Payment of Maintenance Fee, 8th Year, Large Entity 08 Aug, 2018 US7884095
Recordation of Patent Grant Mailed 07 Feb, 2017 US9561200
Patent Issue Date Used in PTA Calculation 07 Feb, 2017 US9561200


Diclofenac Potassium's Family Patents

Family Patents

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Diclofenac Potassium Generic API Manufacturers

Several generic applications have been filed for Diclofenac Potassium. The first generic version for Diclofenac Potassium was by Teva Pharmaceuticals Usa Inc and was approved on Aug 6, 1998. And the latest generic version is by Taro Pharmaceutical Industries Ltd and was approved on Jun 14, 2024.

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


1. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

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

for solution Prescription ORAL AB Jul 20, 2022





2. AMICI PHARMA

Amici Pharma Inc has filed for 2 different strengths of generic version for Diclofenac Potassium. All of these versions come by the name CATAFLAM. Given below are the details of the strengths of this generic introduced by Amici Pharma.

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

tablet Prescription ORAL AB Mar 18, 2004
25MG

tablet Prescription ORAL AB Jul 21, 2021





3. ANNORA PHARMA

Annora Pharma Private Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Annora Pharma.

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

for solution Prescription ORAL AB Mar 4, 2022


Manufacturing Plant Locations
New

Annora Pharma'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 Annora Pharma as present at those locations.

Country City Firm Name
India
Hyderabad Annora Pharma Private Limited





4. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

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

capsule Prescription ORAL AB Oct 19, 2021


Manufacturing Plant Locations
New

Aurobindo Pharma 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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





5. BIONPHARMA

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

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

capsule Prescription ORAL AB Feb 23, 2016


Manufacturing Plant Locations
New

Bionpharma'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 Bionpharma as present at those locations.

Country City Firm Name
United States
Princeton Bionpharma Inc.





6. CHARTWELL RX

Chartwell Rx Sciences Llc has filed for 1 generic for Diclofenac Potassium. 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
50MG

tablet Discontinued ORAL N/A Feb 23, 2001





7. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Endo Operations.

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

for solution Prescription ORAL AB May 2, 2016





8. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Novast Labs.

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

tablet Prescription ORAL AB Oct 8, 2021





9. RK PHARMA

Rk Pharma Inc has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Rk Pharma.

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

(reference standard)

tablet Prescription ORAL AB Jul 26, 1999


Manufacturing Plant Locations
New

Rk Pharma'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 Rk Pharma as present at those locations.

Country City Firm Name
United States
Pearl River RK Pharma Inc.





10. RUBICON

Rubicon Research Private Ltd has filed for 2 different strengths of generic version for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Rubicon.

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

tablet Prescription ORAL AB Nov 20, 1998
25MG

tablet Prescription ORAL AB Sep 16, 2021


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
Indianapolis Rubicon Foods LLC
Geismar Rubicon, LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





11. SENORES PHARMS

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

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

tablet Prescription ORAL AB Mar 15, 2023
25MG

tablet Prescription ORAL AB Nov 9, 2023





12. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Strides Pharma.

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

capsule Prescription ORAL AB Dec 3, 2019


Manufacturing Plant Locations
New

Strides Pharma'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 Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





13. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

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

tablet Discontinued ORAL N/A Feb 21, 2002





14. TARO

Taro Pharmaceutical Industries Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Taro.

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

for solution Prescription ORAL AB Jun 14, 2024


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
Honolulu Taro Delight, LLC
Hawthorne Taro Pharmaceuticals U.S.A., Inc.
Israel
Haifa Taro Pharmaceutical Industries, Ltd.
Canada
Brampton Taro Pharmaceuticals Inc.





15. TEVA

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

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

tablet Prescription ORAL AB Aug 6, 1998


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
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Fort Dodge TEVA Animal Health Inc
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
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.





16. UMEDICA

Umedica Laboratories Private Ltd has filed for 1 generic for Diclofenac Potassium. Given below are the details of the strengths of this generic introduced by Umedica.

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

tablet Prescription ORAL AB May 11, 2022


Manufacturing Plant Locations
New

Umedica'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 Umedica as present at those locations.

Country City Firm Name
India
Vapi Umedica Laboratories Pvt. Ltd.





17. WATSON LABS TEVA

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

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

tablet Discontinued ORAL N/A Nov 27, 1998