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Generated: November 20, 2018

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Teriflunomide - Generic Drug Details

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What are the generic drug sources for teriflunomide and what is the scope of teriflunomide patent protection?

Teriflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Amneal Pharms Co, Teva Pharms Usa, and Watson Labs Teva, and is included in four NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for teriflunomide. Two suppliers are listed for this compound.

Pharmacology for teriflunomide
Synonyms for teriflunomide
(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
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 (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 teriflunomide

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 202992-002 Sep 12, 2012 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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
Amneal Pharms Co TERIFLUNOMIDE teriflunomide TABLET;ORAL 209613-002 Sep 28, 2018 AB RX No 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 ➤ Sign Up
Teva Pharms Usa TERIFLUNOMIDE teriflunomide TABLET;ORAL 209700-001 Sep 4, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 teriflunomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 202992-002 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

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Supplementary Protection Certificates for teriflunomide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0010 France ➤ Sign Up PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2014004 Lithuania ➤ Sign Up PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
14/004 Ireland ➤ Sign Up PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
90010-4 Sweden ➤ Sign Up PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
00644 Netherlands ➤ Sign Up PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Merck
Medtronic
Daiichi Sankyo
McKesson
Argus Health
Cerilliant
Boehringer Ingelheim

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