Teriflunomide Patent Expiration

Teriflunomide is Used for treating patients with relapsing forms of multiple sclerosis. It was first introduced by Sanofi Aventis Us Llc in its drug Aubagio on Sep 12, 2012. 19 different companies have introduced drugs containing Teriflunomide.


Teriflunomide Patents

Given below is the list of patents protecting Teriflunomide, 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
Aubagio US5459163 Medicament to combat autoimmune diseases Oct 17, 2012

(Expired)

Sanofi Aventis Us
Aubagio US5679709 Medicaments to combat autoimmune diseases Oct 21, 2014

(Expired)

Sanofi Aventis Us
Aubagio US6794410 Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Sep 12, 2026 Sanofi Aventis Us
Aubagio US6794410

(Pediatric)

Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis Mar 12, 2027 Sanofi Aventis Us
Aubagio US8802735 (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Sep 14, 2030 Sanofi Aventis Us
Aubagio US8802735

(Pediatric)

(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability Mar 14, 2031 Sanofi Aventis Us
Aubagio US9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Feb 04, 2034 Sanofi Aventis Us
Aubagio US9186346

(Pediatric)

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients Aug 04, 2034 Sanofi Aventis Us


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Teriflunomide Generics

Several generic applications have been filed for Teriflunomide. The first generic version for Teriflunomide was by Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jul 27, 2018. And the latest generic version is by Torrent Pharma Inc and was approved on Apr 4, 2024.

Given below is the list of companies who have filed for Teriflunomide generic.


1. TORRENT

Torrent Pharma Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Apr 4, 2024
7MG tablet Prescription ORAL AB Apr 4, 2024


2. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Jan 7, 2019
7MG tablet Prescription ORAL AB Jan 7, 2019


3. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Discontinued ORAL N/A Feb 28, 2020
14MG tablet Discontinued ORAL N/A Feb 28, 2020


4. BIOCON PHARMA

Biocon Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Prescription ORAL AB Mar 13, 2023
14MG tablet Prescription ORAL AB Mar 13, 2023


5. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Sep 4, 2018
7MG tablet Prescription ORAL AB Sep 4, 2018


6. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Nov 15, 2018
7MG tablet Prescription ORAL AB Nov 15, 2018


7. SANDOZ

Sandoz Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Prescription ORAL AB Jan 3, 2019
14MG tablet Prescription ORAL AB Jan 3, 2019


8. NATCO

Natco Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Prescription ORAL AB May 15, 2023
14MG tablet Prescription ORAL AB May 15, 2023


9. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Mar 13, 2023
7MG tablet Prescription ORAL AB Mar 13, 2023


10. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. 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
7MG tablet Prescription ORAL AB Nov 30, 2018
14MG tablet Prescription ORAL AB Nov 30, 2018


11. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Apr 24, 2019
7MG tablet Prescription ORAL AB Apr 24, 2019


12. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Discontinued ORAL N/A Sep 24, 2021
7MG tablet Discontinued ORAL N/A Sep 24, 2021


13. SOLA PHARMS

Sola Pharmaceuticals has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Sola Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Jun 17, 2020
7MG tablet Prescription ORAL AB Sep 28, 2023


14. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Prescription ORAL AB Apr 19, 2019
14MG tablet Prescription ORAL AB Apr 19, 2019


15. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Prescription ORAL AB Oct 26, 2018
7MG tablet Prescription ORAL AB Oct 26, 2018


16. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
7MG tablet Prescription ORAL AB Nov 2, 2018
14MG tablet Prescription ORAL AB Nov 2, 2018


17. AMNEAL PHARMS CO

Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Teriflunomide. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
14MG tablet Discontinued ORAL N/A Sep 28, 2018
7MG tablet Discontinued ORAL N/A Sep 28, 2018


18. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Teriflunomide. 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
7MG tablet Discontinued ORAL N/A Jul 27, 2018
14MG tablet Discontinued ORAL N/A Jul 27, 2018