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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-eight patent family members in forty-five countries.

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

US ANDA Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by GLENMARK PHARMS on November 15^th, 2018.

Summary for AUBAGIO

International Patents:	78
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	81
Clinical Trials:	9
Patent Applications:	1,001
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

See drug prices for AUBAGIO

Recent Clinical Trials for AUBAGIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis Pharmaceuticals	Phase 3
Genzyme, a Sanofi Company	Phase 4
Montreal Neurological Institute and Hospital	Phase 4

See all AUBAGIO clinical trials

Recent Litigation for AUBAGIO

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Sanofi-Aventis U.S. LLC v. Hetero USA Inc.	2017-01-11
Sanofi-Aventis U.S. LLC v. Zydus Pharmaceuticals (USA) Inc.	2017-01-11
Sanofi-Aventis U.S. LLC v. Mylan Pharmaceuticals Inc.	2017-01-10

See all AUBAGIO litigation

Pharmacology for AUBAGIO

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Synonyms for AUBAGIO

(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

163451-81-8 (Z Isomer) , 108605-62-5 (E/Z Mixture)

1C058IKG3B

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

A 1726

A 77-1726

A 77-1726;A771726;HMR1726;CAS# 108605-62-5

A 771726

A-771726

A26

A77 1726

A77-1726

A771726

A801897

AB01565775_02

AC-26446

Active metabolite of leflunomide

AKOS015994773

API0000341

Aubagio (TN)

BDBM50018011

C-16971

CC-10329

CHEBI:68540

D10172

DB08880

DTXSID80893457

EN300-189832

Flucyamide

GTPL6844

HMR 1726

HMR-1726

HMR1726

J-010046

LE-0275

Leflunomide EP Impurity B

Leflunomide Related Compound B

Leflunomide related compound b rs

Leflunomide Related Compound B, United States Pharmacopeia (USP) Reference Standard

Leflunomide-d4 Metabolite (Teriflunomide-d4)

LS-46899

Malononitrilamide

N-(4-Trifluoromethylphenyl)-2-cyano-2-hydroxycrotonamide

N-(4-trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide

N-[4-(Trifluoromethyl)phenyl]-2-cyano-3-hydroxycrotonamide

Q3077133

RS 61980

RS-61980

RT-011141

s4169

SB16822

SC-90977

SCHEMBL22661

ST24036515

SU 20

SU-0020

SW219377-1

Teriflunamide

teriflunomida

Teriflunomide

Teriflunomide (USAN)

Teriflunomide [INN]

Teriflunomide [USAN:INN]

Teriflunomide, A77 1726

Teriflunomide; Leflunomide USP RC B; Cyano Keto leflunomide impurity; N-(4-Trifluoromethylphenyl)-2-cyano-3-hydroxycrotonamide; 2-Cyano-3-hydroxy-N-[4-(trifluoromethyl)phenyl]-2-beuteamide

Teriflunomide(A-771726)

Teriflunomide(Random Configuration)

teriflunomidum

UNII-1C058IKG3B

UTNUDOFZCWSZMS-YFHOEESVSA-N

ZINC13512456

Paragraph IV (Patent) Challenges for AUBAGIO

Tradename	Dosage	Ingredient	NDA	Submissiondate
AUBAGIO	TABLET;ORAL	teriflunomide	202992	2016-09-12

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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes

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

International Patents for AUBAGIO

Country	Patent Number	Estimated Expiration
Japan	H0729918
Portugal	1381356
Japan	S6272614
European Patent Office	1381356
Peru	20121478
Japan	2607848
Austria	396719

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	SPC/GB14/011	United Kingdom		PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
1381356	PA2014004	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	CR 2014 00005	Denmark		PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	PA2014004,C1381356	Lithuania		PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	122014000009	Germany		PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	C300644	Netherlands		PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	486	Finland