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Last Updated: May 26, 2020

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AUBAGIO Drug 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-eight patent family members in forty-five countries.

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

US ANDA Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by GLENMARK PHARMS on November 15th, 2018.

  Start Trial

Drug patent expirations by year for AUBAGIO
Drug Prices for AUBAGIO

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Recent Clinical Trials for AUBAGIO

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

SponsorPhase
Novartis PharmaceuticalsPhase 3
Genzyme, a Sanofi CompanyPhase 4
Montreal Neurological Institute and HospitalPhase 4

See all AUBAGIO clinical trials

Recent Litigation for AUBAGIO

Identify potential future generic entrants

District Court Litigation
Case NameDate
Sanofi-Aventis U.S. LLC v. Hetero USA Inc.2017-01-11
Sanofi-Aventis U.S. LLC v. Zydus Pharmaceuticals (USA) Inc.2017-01-11
Sanofi-Aventis U.S. LLC v. Mylan Pharmaceuticals Inc.2017-01-10

See all AUBAGIO litigation

Pharmacology for AUBAGIO
Synonyms for AUBAGIO
(2Z)-2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
(2z)-2-Cyano-3-Hydroxy-N-[4-(Trifluoromethyl)phenyl]but-2-Enamide
(2Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide (Teriflunomide)
(2Z)-3-oxidanylidene-2-[oxidanyl-[[4-(trifluoromethyl)phenyl]amino]methylidene]butanenitrile
(Z)-2-Cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide
(Z)-2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-butenamide
(Z)-2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]but-2-enamide
(Z)-2-cyano-alpha,alpha,alpha-trifluoro-3-hydroxy-p-crotonotoluidide
(Z)-2-Cyano-alpha'alpha'alpha-trifluoro-3-hydroxy-p-crotonotoluidide
108605-62-5
1185240-22-5
163451-81-8
163451-81-8 (Z Isomer) , 108605-62-5 (E/Z Mixture)
1C058IKG3B
2-Butenamide, 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-
2-Butenamide, 2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-, (Z)-
2-Butenamide, 2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-
2-Butenamide, 2-cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-, (2Z)-
2-Cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)-2-butenamide
2-cyano-3-hydroxy-N-(4-(trifluoromethyl)phenyl)but-2-enamide
2-cyano-3-hydroxy-n-[4-(trifluoromethyl)phenyl]-2-butenamide
2-Cyano-3-OH-N-(4-trifluoromethylphenyl)croton amide
2-hydroxyethylidene-cyanoacetic acid-4-trifluoromethyl anilide
A 1726
A 77-1726
A 77-1726;A771726;HMR1726;CAS# 108605-62-5
A 771726
A-771726
A26
A77 1726
A77-1726
A771726
A801897
AB01565775_02
AC-26446
Active metabolite of leflunomide
AKOS015994773
API0000341
Aubagio (TN)
BDBM50018011
C-16971
CC-10329
CHEBI:68540
D10172
DB08880
DTXSID80893457
EN300-189832
Flucyamide
GTPL6844
HMR 1726
HMR-1726
HMR1726
J-010046
LE-0275
Leflunomide EP Impurity B
Leflunomide Related Compound B
Leflunomide related compound b rs
Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard
Leflunomide-d4 Metabolite (Teriflunomide-d4)
LS-46899
Malononitrilamide
N-(4-Trifluoromethylphenyl)-2-cyano-2-hydroxycrotonamide
N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide
N-[4-(Trifluoromethyl)phenyl]-2-cyano-3-hydroxycrotonamide
Q3077133
RS 61980
RS-61980
RT-011141
s4169
SB16822
SC-90977
SCHEMBL22661
ST24036515
SU 20
SU-0020
SW219377-1
Teriflunamide
teriflunomida
Teriflunomide
Teriflunomide (USAN)
Teriflunomide [INN]
Teriflunomide [USAN:INN]
Teriflunomide, A77 1726
Teriflunomide; Leflunomide USP RC B; Cyano Keto leflunomide impurity; N-(4-Trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide; 2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-beuteamide
Teriflunomide(A-771726)
Teriflunomide(Random Configuration)
teriflunomidum
UNII-1C058IKG3B
UTNUDOFZCWSZMS-YFHOEESVSA-N
ZINC13512456
Paragraph IV (Patent) Challenges for AUBAGIO
Tradename Dosage Ingredient NDA Submissiondate
AUBAGIO TABLET;ORAL teriflunomide 202992 2016-09-12

US Patents and Regulatory Information for AUBAGIO

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   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes   Start Trial   Start Trial   Start 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 202992-001 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for AUBAGIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 SPC/GB14/011 United Kingdom   Start Trial PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
1381356 PA2014004 Lithuania   Start Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 CR 2014 00005 Denmark   Start Trial PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356 PA2014004,C1381356 Lithuania   Start Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 122014000009 Germany   Start Trial PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 C300644 Netherlands   Start Trial PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 486 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
AstraZeneca
Medtronic
Express Scripts
Harvard Business School

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