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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.

Summary for teriflunomide

International Patents:	75
US Patents:	3
Tradenames:	2
Applicants:	10
NDAs:	10
Drug Master File Entries:	19
Suppliers / Packagers:	3
Bulk Api Vendors:	74
Clinical Trials:	32
Patent Applications:	1,578
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

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
Accord Hlthcare	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690-001	Jan 7, 2019	AB	RX	No	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No			Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No
Sandoz Inc	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209710-001	Jan 3, 2019	AB	RX	No	No
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-002	Nov 15, 2018	AB	RX	No	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes			Y

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
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

International Patents for teriflunomide

Country	Patent Number	Estimated Expiration
Mexico	2012003122
South Korea	101547880
Hungary	E032963
Argentina	078383
Japan	2013505213
Guatemala	201200075
Taiwan	201517935

Supplementary Protection Certificates for teriflunomide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	PA2014004,C1381356	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	PA2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	CA 2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	1490010-4	Sweden		PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356	C 2014 006	Romania		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		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	486	Finland