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.
Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List
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
Verna
Micro Labs Limited
Bengaluru
Micro Labs Limited
Bengaluru
Micro Labs Limited, Central Analytical Laboratory
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
Princeton
Sandoz Inc
East Hanover
Sandoz Incorporated
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.
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.