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Last Updated: July 23, 2024

AUBAGIO Drug Patent Profile


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When do Aubagio patents expire, and when can generic versions of Aubagio launch?

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

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Recent Clinical Trials for AUBAGIO

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SponsorPhase
Beijing HospitalPhase 2
Peking University People's HospitalPhase 2
Navy General Hospital, BeijingPhase 2

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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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
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Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting AUBAGIO

REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 ⤷  Sign Up ⤷  Sign Up
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 ⤷  Sign Up ⤷  Sign Up
>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
Israel 218492 פורמולציה של טבלייה עם (z)-2-ציאנו-3-הידרוקסי-באט-2 חומצה אנואית-(4' -טריפלואורומתילפניל)-אמיד ((z)-2-cyano-3-hydroxy-but-3-enoic acid-(4'-trifluoromethylphenyl)-amide tablet formulations with improved stability) ⤷  Sign Up
Uruguay 32889 FORMULACIONES EN COMPRIMIDO DE LA (4 ́-TRIFLUOROMETILFENIL)AMIDA DEL ÁCIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON MAYOR ESTABILIDAD ⤷  Sign Up
Japan H05208908 CHRONIC PAIR HOST TRANSPLANTATION PIECE DISEASE REMEDY ⤷  Sign Up
Tunisia 2012000061 (Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY ⤷  Sign Up
European Patent Office 1381356 UTILISATION DE L'ACIDE (Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIQUE-(4'-TRIFLUOROMETHYLPHENYL)-AMIDE POUR LE TRAITEMENT DE LA SCLEROSE EN PLAQUES (USE OF (Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUOROMETHYLPHENYL)-AMIDE FOR TREATING MULTIPLE SCLEROSIS) ⤷  Sign Up
Israel 244809 פורמולצית טבליה של (z)-2-ציאנו-3-הידרוקסי-באט-2 חומצה אנואית-(4' טריפלורומתילפניל)-אמיד ((z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability) ⤷  Sign Up
Ukraine 107582 ТАБЛЕТОВАНИЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНІЛ)АМІДУ (Z)-2-ЦІАНО-ГІДРОКСИБУТ-2-ЕНОЄВОЇ КИСЛОТИ З ПОЛІПШЕНОЮ СТІЙКІСТЮ ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AUBAGIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 92366 Luxembourg ⤷  Sign Up PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356 CR 2014 00005 Denmark ⤷  Sign Up PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356 1490010-4 Sweden ⤷  Sign Up PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356 132014902231965 Italy ⤷  Sign Up AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356 CA 2014 00005 Denmark ⤷  Sign Up PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356 PA2014004 Lithuania ⤷  Sign Up PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 C01381356/01 Switzerland ⤷  Sign Up FORMER OWNER: AVENTISUB LLC, US
>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.