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Last Updated: March 28, 2024

AUBAGIO Drug Patent Profile


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When do Aubagio patents expire, and what generic alternatives are available?

Aubagio is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-nine patent family members in forty-six countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by TEVA PHARMS USA on September 4th, 2018.

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Drug patent expirations by year for AUBAGIO
Drug Prices for AUBAGIO

See drug prices for AUBAGIO

Recent Clinical Trials for AUBAGIO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
EMD Serono Research & Development Institute, Inc.Phase 3
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 3
Novartis PharmaceuticalsPhase 3

See all AUBAGIO clinical trials

Pharmacology for AUBAGIO
Paragraph IV (Patent) Challenges for AUBAGIO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AUBAGIO Tablets teriflunomide 7 mg and 14 mg 202992 21 2016-09-12

US Patents and Regulatory Information for AUBAGIO

AUBAGIO is protected by three US patents and two FDA Regulatory Exclusivities.

Patents protecting AUBAGIO

Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting AUBAGIO

REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AUBAGIO

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for AUBAGIO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Sanofi Winthrop Industrie Aubagio teriflunomide EMEA/H/C/002514
AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Authorised no no no 2013-08-26
Accord Healthcare S.L.U. Teriflunomide Accord teriflunomide EMEA/H/C/005960
Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).
Authorised yes no no 2022-11-09
Mylan Pharmaceuticals Limited Teriflunomide Mylan teriflunomide EMEA/H/C/005962
Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established). 
Authorised yes no no 2022-11-09
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for AUBAGIO

See the table below for patents covering AUBAGIO around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 2477611 FORMULATIONS DE COMPRIMÉS D'ACIDE (Z)-2-CYANO-3-HYDROXY-BUT-2-ÉNOÏQUE-(4'-TRIFLUORMÉTHYLPHÉNYL)-AMIDE À STABILITÉ AMÉLIORÉE ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY) ⤷  Try a Trial
China 102596184 (z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability ⤷  Try a Trial
Dominican Republic P2012000070 FORMULACIONES EN COMPRIMIDO DE LA (4-TRIFLUOROMETILFENIL) AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON ESTABILIDAD MEJORADA ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AUBAGIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 1490010-4 Sweden ⤷  Try a Trial PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356 PA2014004 Lithuania ⤷  Try a Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 C300644 Netherlands ⤷  Try a Trial PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.