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Generated: December 19, 2018

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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-two patent family members in forty-three countries.

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

Drug patent expirations by year for AUBAGIO
Pharmacology for AUBAGIO
Synonyms for AUBAGIO
(2E)-2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
(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
1C058IKG3B
2-[hydroxy-[4-(trifluoromethyl)anilino]methylidene]-3-oxobutanenitrile
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
210165-52-9
A 1726
A 77-1726
A 771726
A-771726
A77 1726
A77-1726
A77-1726 (monosodium salt)
A771726
A801897
AB01565775_02
AC-26446
AC1L1GYH
AC1L9H6I
AC1NUIOH
Active metabolite of leflunomide
AJ-63994
AK116138
AK144826
AKOS015994773
API0000341
Aubagio (TN)
BDBM50018011
C-16971
CC-10329
CHEBI:68540
CS-1031
D05LAR
D07QFP
D08TRA
D09PUR
D10172
DB08880
EN300-189832
Flucyamide
GTPL6844
HMR 1726
HMR-1726
HMR1726
HY-15405
J-010046
KB-80843
LE-0275
Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard
Leflunomide-d4 Metabolite (Teriflunomide-d4)
LS-46899
Malononitrilamide
MFCD00910058
MolPort-005-943-824
MolPort-035-386-190
N-(4-Trifluoromethylphenyl)-2-cyano-2-hydroxycrotonamide
N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide
N-(4-Trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide, 2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-beuteamide, LEF-M
N-[4-(Trifluoromethyl)phenyl]-2-cyano-3-hydroxycrotonamide
RS 61980
RS-61980
RT-011141
s4169
SC-90977
SCHEMBL22661
Simvistatin
ST24036515
SU 20
SU-0020
Teriflunamide
teriflunomida
Teriflunomide
Teriflunomide (USAN)
Teriflunomide [INN]
Teriflunomide [USAN:INN]
Teriflunomide, A77 1726
Teriflunomide(A-771726)
teriflunomidum
UNII-1C058IKG3B
UTNUDOFZCWSZMS-YFHOEESVSA-N
ZINC13512456

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

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

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Paragraph IV (Patent) Challenges for AUBAGIO
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 7 mg and 14 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for AUBAGIO

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
366 Luxembourg ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
6 Finland ➤ Try a Free Trial
14/004 Ireland ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2014 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Express Scripts
Medtronic
US Army
Citi
US Department of Justice
Harvard Business School
Chinese Patent Office

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