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Diclofenac Sodium; Misoprostol Patent Expiration

Diclofenac Sodium; Misoprostol was first introduced by Pfizer Inc in its drug Arthrotec on Dec 24, 1997. 8 different companies have introduced drugs containing Diclofenac Sodium; Misoprostol.


Diclofenac Sodium; Misoprostol Patents

Given below is the list of patents protecting Diclofenac Sodium; Misoprostol, 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
Arthrotec US5601843 Pharmaceutical tablet composition Feb 11, 2014

(Expired)

 Pfizer



Diclofenac Sodium; Misoprostol's Family Patents

Family Patents

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Diclofenac Sodium; Misoprostol Generic API Manufacturers

Several generic applications have been filed for Diclofenac Sodium; Misoprostol. The first generic version for Diclofenac Sodium; Misoprostol was by Actavis Laboratories Fl Inc and was approved on Jul 9, 2012. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Jun 12, 2023.

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


1. ACTAVIS LABS FL INC

Actavis Laboratories Fl Inc has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
75MG; 0.2MG

tablet, delayed release Prescription ORAL AB Jul 9, 2012
50MG; 0.2MG

tablet, delayed release Prescription ORAL AB Jul 9, 2012





2. AMNEAL PHARMS

Amneal Pharmaceuticals has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. 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
50MG; 0.2MG

tablet, delayed release Prescription ORAL AB Nov 25, 2016
75MG; 0.2MG

tablet, delayed release Prescription ORAL AB Nov 25, 2016





3. EXELA HOLDINGS

Exela Holdings Inc has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. Given below are the details of the strengths of this generic introduced by Exela Holdings.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A Mar 14, 2014
75MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A Mar 14, 2014





4. MICRO LABS

Micro Labs Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. 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; 0.2MG

tablet, delayed release Prescription ORAL AB Jul 15, 2021
75MG; 0.2MG

tablet, delayed release Prescription ORAL AB Jul 15, 2021


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
Bangalore Micro Labs Limited
Bengaluru Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Verna Micro Labs Limited





5. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A May 9, 2013
75MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A May 9, 2013


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





6. YUNG SHIN PHARM

Yung Shin Pharmaceutical Industrial Co Ltd has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. Given below are the details of the strengths of this generic introduced by Yung Shin Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 0.2MG

tablet, delayed release Prescription ORAL AB Feb 19, 2020
75MG; 0.2MG

tablet, delayed release Prescription ORAL AB Feb 19, 2020


Manufacturing Plant Locations
New

Yung Shin Pharm's manufacturing plants are situated in 2 countries - China, Taiwan. Given below are the details of these plant locations as well as the firm names of Yung Shin Pharm as present at those locations.

Country City Firm Name
China
Kunshan Yung Shin Pharmaceutical Industrial (Kunshan) Co., Ltd.
Taiwan
Taichung City Yung Shin Pharmaceutical Industry Co., Ltd.





7. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Diclofenac Sodium; Misoprostol. All of these versions come by the name DICLOFENAC SODIUM AND MISOPROSTOL. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A Jun 12, 2023
75MG; 0.2MG

tablet, delayed release Discontinued ORAL N/A Jun 12, 2023