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Generic Aubagio Availability

Last updated on Nov 7, 2023.

Aubagio is a brand name of teriflunomide, approved by the FDA in the following formulation(s):

AUBAGIO (teriflunomide - tablet;oral)

Has a generic version of Aubagio been approved?

A generic version of Aubagio has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Aubagio and have been approved by the FDA:

teriflunomide tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: January 7, 2019
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: ALEMBIC
    Approval date: April 19, 2019
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: AMNEAL PHARMS CO
    Approval date: September 28, 2018
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: APOTEX
    Approval date: November 2, 2018
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: AUROBINDO PHARMA
    Approval date: October 26, 2018
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: BIOCON PHARMA
    Approval date: March 13, 2023
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: GLENMARK PHARMS
    Approval date: November 15, 2018
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: March 13, 2023
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: MSN
    Approval date: April 24, 2019
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: MYLAN
    Approval date: February 28, 2020
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: NATCO
    Approval date: May 15, 2023
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: SANDOZ
    Approval date: January 3, 2019
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: SOLA PHARMS
    Approval date: June 17, 2020
    Strength(s): 14MG [AB]
  • Manufacturer: SOLA PHARMS
    Approval date: September 28, 2023
    Strength(s): 7MG [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: September 4, 2018
    Strength(s): 7MG [AB], 14MG [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: November 30, 2018
    Strength(s): 7MG [AB], 14MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Aubagio. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Patent 6,794,410
    Issued: November 30, -0001

    Patent expiration dates:

    • September 12, 2026
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
  • Patent 6794410*PED
    Issued: November 30, -0001

    Patent expiration dates:

    • March 12, 2027
      ✓ 
      Pediatric exclusivity
  • (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
    Patent 8,802,735
    Issued: August 12, 2014
    Inventor(s): Hauck Gerrit
    Assignee(s): Sanofi

    The invention relates to solid pharmaceutical compositions comprising (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide, as well as a process for the preparation of the same, methods of using such compositions to treat subjects suffering from autoimmune diseases in particular systemic lupus erythematosus or chronic graft-versus-host disease, multiple sclerosis or rheumatoid arthritis.

    Patent expiration dates:

    • September 14, 2030
      ✓ 
      Drug product
  • (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
    Patent 8802735*PED
    Issued: August 12, 2014
    Inventor(s): Hauck Gerrit
    Assignee(s): Sanofi

    The invention relates to solid pharmaceutical compositions comprising (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide, as well as a process for the preparation of the same, methods of using such compositions to treat subjects suffering from autoimmune diseases in particular systemic lupus erythematosus or chronic graft-versus-host disease, multiple sclerosis or rheumatoid arthritis.

    Patent expiration dates:

    • March 14, 2031
      ✓ 
      Pediatric exclusivity
  • Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
    Patent 9,186,346
    Issued: November 17, 2015
    Inventor(s): Weitz Dietmar & Menguy-Vacheron Francoise & Clot Pierre-Francois & Turpault Sandrine
    Assignee(s): SANOFI

    This invention relates to a method for managing the risk of an adverse interaction between teriflunomide and a substrate of breast cancer resistance protein (BCRP) and/or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3).

    Patent expiration dates:

    • February 4, 2034
      ✓ 
      Patent use: TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE
  • Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
    Patent 9186346*PED
    Issued: November 17, 2015
    Inventor(s): Weitz Dietmar & Menguy-Vacheron Francoise & Clot Pierre-Francois & Turpault Sandrine
    Assignee(s): SANOFI

    This invention relates to a method for managing the risk of an adverse interaction between teriflunomide and a substrate of breast cancer resistance protein (BCRP) and/or organic anion transporting polypeptide B1 and B3 (OATP1B1/B3).

    Patent expiration dates:

    • August 4, 2034
      ✓ 
      Pediatric exclusivity

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • April 30, 2024 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • October 30, 2024 - PEDIATRIC EXCLUSIVITY

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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