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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, Apotex Inc, Aurobindo Pharma Ltd, Glenmark Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms Usa Inc, and is included in eight 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-two patent family members in forty-three countries.

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

Summary for teriflunomide

International Patents:	72
US Patents:	3
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	19
Suppliers / Packagers:	3
Bulk Api Vendors:	72
Clinical Trials:	31
Patent Applications:	1,392
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teriflunomide
DailyMed Link:	teriflunomide at DailyMed

Pharmacology for teriflunomide

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

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
Zydus Pharms Usa Inc	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209668-002	Nov 30, 2018	AB	RX	No	No
Teva Pharms Usa	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209700-001	Sep 4, 2018	AB	RX	No	No
Watson Labs Teva	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209549-002	Jul 27, 2018	AB	RX	No	No
Apotex Inc	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209601-002	Nov 2, 2018	AB	RX	No	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-002	Nov 15, 2018	AB	RX	No	No

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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012

International Patents for teriflunomide

Country	Document Number	Estimated Expiration
Malaysia	155613
Ukraine	115979
South Korea	20120089461
China	104739821
Colombia	6511244
Morocco	33585
Taiwan	I468190

Supplementary Protection Certificates for teriflunomide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356/01	Switzerland		FUSION; FORMER OWNER: AVENTIS PHARMACEUTICALS INC., US
C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
366	Luxembourg		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
14/004	Ireland		PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826