AUBAGIO Drug Patent Profile

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. Twenty-two suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by TEVA PHARMS USA on September 4^th, 2018.

Summary for AUBAGIO

International Patents:	79
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	12
Patent Applications:	2,801
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

Anatomical Therapeutic Chemical (ATC) Classes for AUBAGIO

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for AUBAGIO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AUBAGIO	Tablets	teriflunomide	7 mg and 14 mg	202992	21	2016-09-12

US Patents and Regulatory Information for AUBAGIO

AUBAGIO is protected by three US patents and two FDA Regulatory Exclusivities.

Patents protecting AUBAGIO

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

EU/EMA Drug Approvals for AUBAGIO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sanofi Winthrop Industrie	Aubagio	teriflunomide	EMEA/H/C/002514 AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).	Authorised	no	no	no	2013-08-26
Accord Healthcare S.L.U.	Teriflunomide Accord	teriflunomide	EMEA/H/C/005960 Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established).	Authorised	yes	no	no	2022-11-09
Mylan Pharmaceuticals Limited	Teriflunomide Mylan	teriflunomide	EMEA/H/C/005962 Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established).	Authorised	yes	no	no	2022-11-09

International Patents for AUBAGIO

See the table below for patents covering AUBAGIO around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	2033	New derivative of cyano crotonamide as medicament with immunomodulating properties
China	104666272	(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Australia	2013257516
World Intellectual Property Organization (WIPO)	02080897
China	104739821	(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability

Supplementary Protection Certificates for AUBAGIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	1490010-4	Sweden		PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
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	C01381356/01	Switzerland		FORMER OWNER: AVENTISUB LLC, US
1381356	14C0010	France		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826