Diclofenac Sodium; Misoprostol Patent Expiration
Diclofenac Sodium; Misoprostol was first introduced by Pfizer Inc
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

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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 | ||||||||
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India |
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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 | ||||
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Austria |
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United States |
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Spain |
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India |
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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 | ||
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China |
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Taiwan |
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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 |