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Generated: June 18, 2019

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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, Accord Hlthcare, Amneal Pharms Co, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms, Sandoz Inc, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in ten NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Teriflunomide has seventy-five patent family members in forty-four countries.

There are nineteen drug master file entries for teriflunomide. Three 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
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
D10172
DB08880
EN300-189832
Flucyamide
GTPL6844
HMR 1726
HMR-1726
HMR1726
HY-15405
J-010046
KB-80843
LE-0275
Leflunomide Impurity B
Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard
Leflunomide-d4 Metabolite (Teriflunomide-d4)
LS-46899
Malononitrilamide
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
SB16822
SC-90977
SCHEMBL22661
ST24036515
SU 20
SU-0020
SW219377-1
Teriflunamide
teriflunomida
Teriflunomide (USAN)
Teriflunomide [INN]
Teriflunomide [USAN:INN]
Teriflunomide, A77 1726
Teriflunomide(A-771726)
Teriflunomide(Random Configuration)
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
Zydus Pharms Usa Inc TERIFLUNOMIDE teriflunomide TABLET;ORAL 209668-001 Nov 30, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare TERIFLUNOMIDE teriflunomide TABLET;ORAL 209690-001 Jan 7, 2019 AB RX No 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 202992-001 Sep 12, 2012 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sandoz Inc TERIFLUNOMIDE teriflunomide TABLET;ORAL 209710-001 Jan 3, 2019 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Glenmark Pharms TERIFLUNOMIDE teriflunomide TABLET;ORAL 209663-002 Nov 15, 2018 AB RX No 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 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 teriflunomide

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 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
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 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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Supplementary Protection Certificates for teriflunomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 PA2014004,C1381356 Lithuania ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 PA2014004 Lithuania ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 CA 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
1381356 1490010-4 Sweden ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356 C 2014 006 Romania ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826
1381356 14C0010 France ➤ Try a Free Trial PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 486 Finland ➤ Try a Free Trial
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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