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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-nine patent family members in forty-six countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Four 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:	79
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	89
Clinical Trials:	13
Patent Applications:	2,313
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AUBAGIO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AUBAGIO
What excipients (inactive ingredients) are in AUBAGIO?	AUBAGIO excipients list
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
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Phase 3
EMD Serono Research & Development Institute, Inc.	Phase 3
Novartis Pharmaceuticals	Phase 3

See all AUBAGIO clinical trials

Pharmacology for AUBAGIO

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

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

Expired US Patents for AUBAGIO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	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 AUBAGIO

Country	Patent Number	Estimated Expiration
Spain	2305287
Brazil	112012006184
Taiwan	I522130
Japan	H05208908

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	132014902231965	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 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	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