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AUBAGIO Drug Profile

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When do Aubagio patents expire, and when can generic versions of Aubagio launch?

Aubagio is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in forty-three countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

Summary for AUBAGIO

International Patents:	72
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	72
Clinical Trials:	9
Patent Applications:	786
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AUBAGIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AUBAGIO
DailyMed Link:	AUBAGIO at DailyMed

Pharmacology for AUBAGIO

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Synonyms for AUBAGIO

(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 (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

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 AUBAGIO

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	202992-001	Sep 12, 2012	AB	RX	Yes	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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No			Y
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes			Y

Expired US Patents for AUBAGIO

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

Paragraph IV (Patent) Challenges for AUBAGIO

Drugname	Dosage	Strength	RLD	Date
	Tablets	7 mg and 14 mg

International Patents for AUBAGIO

Country	Document Number	Estimated Expiration
Colombia	6511244
Morocco	33585
Chile	2015000047
New Zealand	617025
Hong Kong	1206245

Supplementary Protection Certificates for AUBAGIO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
6	Finland
14/004	Ireland		PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; 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