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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 one branded drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this compound. 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. One supplier is listed for this compound.

Summary for teriflunomide

International Patents:	72
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	19
Suppliers / Packagers:	1
Bulk Api Vendors:	68
Clinical Trials:	28
Patent Applications:	1,348
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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012		RX	Yes	Yes
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012		RX	Yes	Yes			Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012		RX	Yes	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012		RX	Yes	Yes

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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
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

Non-Orange Book US Patents for teriflunomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,569,898	United States Patent: 6569898   ( 1

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International Patents for teriflunomide

Country	Document Number	Estimated Expiration
Panama	8542901
Japan	2013505213
New Zealand	598744
Peru	14782012

Supplementary Protection Certificates for teriflunomide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
366	Luxembourg		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
90010-4	Sweden		PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
2014004,C1381356	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