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Tretinoin Patent Expiration

Tretinoin was first introduced by Valeant International Barbados Srl in its drug Retin-A on Approved Prior to Jan 1, 1982. Other drugs containing Tretinoin are Avita, Atralin, Renova, Retin-A-Micro, Altreno, Vesanoid, Retin-A Micro. 22 different companies have introduced drugs containing Tretinoin.


Tretinoin Patents

Given below is the list of patents protecting Tretinoin, 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
Altreno US10653656 Topical pharmaceutical compositions for treating skin conditions Aug 22, 2038 Dow Pharm
Altreno US11324710 Topical pharmaceutical compositions for treating skin conditions Aug 22, 2038 Dow Pharm
Altreno US6517847 Topical gel delivery system Aug 03, 2020

(Expired)

 Dow Pharm
Renova US6531141 Oil-in-water emulsion containing tretinoin Mar 07, 2020

(Expired)

 Valeant Pharms North
Retin-a Micro US5955109 Methods and compositions for topical delivery of retinoic acid Sep 21, 2016

(Expired)

 Bausch
Retin-a-micro US5955109 Methods and compositions for topical delivery of retinoic acid Sep 21, 2016

(Expired)

 Bausch
Atralin US5670547 Moisturizing vehicle for topical application of vitamin A acid Sep 23, 2014

(Expired)

 Dow Pharm



Tretinoin's Family Patents

Family Patents

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Tretinoin Generic API Manufacturers

Several generic applications have been filed for Tretinoin. The first generic version for Tretinoin was by Teva Pharmaceuticals Usa and was approved on Jun 19, 1998. And the latest generic version is by Encube Ethicals Private Ltd and was approved on Mar 3, 2025.

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


1. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 1 generic for Tretinoin. Given below are the details of the strengths of this generic introduced by Alembic.

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

cream Prescription TOPICAL AB Apr 29, 2024


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
Vadodara Alembic Pharmaceuticals, Ltd
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited





2. ALLERGAN

Allergan Sales Llc has filed for 2 different strengths of generic version for Tretinoin. Given below are the details of the strengths of this generic introduced by Allergan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.0375%

cream Discontinued TOPICAL N/A Mar 22, 2010
0.075%

cream Discontinued TOPICAL N/A Oct 11, 2012


Manufacturing Plant Locations
New

Allergan's manufacturing plants are situated in 4 countries - United States, Costa Rica, France, Ireland. Given below are the details of these plant locations as well as the firm names of Allergan as present at those locations.

Country City Firm Name
United States
Cincinnati Allergan Sales LLC
Irvine Allergan Sales, LLC
Madison ALLERGAN SALES, LLC
Campbell Allergan Sales, LLC dba Bioscience Laboratories
Goleta Allergan
Waco Allergan Sales, LLC
Costa Rica
Heredia ALLERGAN
France
Pringy Allergan Industrie SAS
Ireland
Westport Allergan Pharmaceuticals Ireland





3. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Tretinoin. 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
0.01%

gel Prescription TOPICAL AB Jan 13, 2025
0.025%

gel Prescription TOPICAL AB Feb 27, 2025


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





4. BARR LABS INC

Barr Laboratories Inc has filed for 1 generic for Tretinoin. Given below are the details of the strengths of this generic introduced by Barr Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

capsule Discontinued ORAL N/A Jun 22, 2007





5. ENCUBE

Encube Ethicals Private Ltd has filed for 3 different strengths of generic version for Tretinoin. Out of these 0.08% version comes by the name TRETINOIN MICROSPHERE. Given below are the details of the strengths of this generic introduced by Encube.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.08%

gel Prescription TOPICAL AB Aug 22, 2023
0.01%

gel Prescription TOPICAL AB Mar 3, 2025
0.025%

gel Prescription TOPICAL AB Mar 3, 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.





6. ENDO OPERATIONS

Endo Operations Ltd has filed for 1 generic for Tretinoin. 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
10MG

(reference standard)

capsule Prescription ORAL AB Oct 24, 2012





7. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 1 generic for Tretinoin. 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
10MG

capsule Prescription ORAL AB Dec 23, 2016





8. MYLAN

Mylan Pharmaceuticals Inc has filed for 1 generic for Tretinoin. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

gel Prescription TOPICAL AB Aug 13, 2015


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
San Carlos Mylan Pharmaceuticals Inc.
Greensboro Mylan Pharmaceuticals Inc
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
India
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





9. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 2 different strengths of generic version for Tretinoin. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

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

gel Discontinued TOPICAL N/A Jul 17, 2013
0.04%

gel Discontinued TOPICAL N/A Jul 17, 2013





10. PADAGIS US

Padagis Us Llc has filed for 4 different strengths of generic version for Tretinoin. Given below are the details of the strengths of this generic introduced by Padagis Us.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

cream Prescription TOPICAL AB1 Dec 24, 1998
0.025%

gel Prescription TOPICAL AB Feb 22, 2000
0.1%

cream Prescription TOPICAL AB Dec 24, 1998
0.01%

gel Prescription TOPICAL AB Jun 11, 2002


Manufacturing Plant Locations
New

Padagis Us'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 Padagis Us as present at those locations.

Country City Firm Name
United States
Minneapolis Padagis US LLC





11. TARO

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

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

cream Prescription TOPICAL AB Jan 22, 2019
0.05%

cream Prescription TOPICAL AB1 Jan 25, 2019
0.025%

cream Prescription TOPICAL AB Jan 5, 2023


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.





12. TEVA PHARMS

Teva Pharmaceuticals Usa has filed for 1 generic for Tretinoin. 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
0.05%

solution Discontinued TOPICAL N/A Jun 19, 1998





13. WOCKHARDT

Wockhardt Eu Operations (swiss) Ag has filed for 1 generic for Tretinoin. Given below are the details of the strengths of this generic introduced by Wockhardt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution Discontinued TOPICAL N/A Jan 25, 1999


Manufacturing Plant Locations
New

Wockhardt'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 Wockhardt as present at those locations.

Country City Firm Name
India
Ankleshwar Wockhardt, Ltd.
Solan, Nalagarh Wockhardt Limited - Baddi
Aurangabad Wockhardt Limited





14. ZO SKIN HEALTH

Zo Skin Health has filed for 1 generic for Tretinoin. Given below are the details of the strengths of this generic introduced by Zo Skin Health.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

cream Discontinued TOPICAL N/A Sep 15, 2005


Manufacturing Plant Locations
New

Zo Skin Health'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 Zo Skin Health as present at those locations.

Country City Firm Name
United States
Irvine ZO Skin Health, Inc.





15. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 1 generic for Tretinoin. 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
0.1%

cream Prescription TOPICAL AB Apr 25, 2024


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
Thane Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Dabhasa Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited