Teriflunomide - Generic Drug Details

What are the generic drug sources for teriflunomide and what is the scope of patent protection?

Teriflunomide is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Alembic Pharms Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Breckenridge, Glenmark Pharms, MSN, Mylan, Sandoz Inc, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in fifteen NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Teriflunomide has seventy-nine patent family members in forty-six countries.

There are nineteen drug master file entries for teriflunomide. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for teriflunomide

International Patents:	79
US Patents:	3
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	51
Patent Applications:	4,836
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for teriflunomide
What excipients (inactive ingredients) are in teriflunomide?	teriflunomide excipients list
DailyMed Link:	teriflunomide at DailyMed

Recent Clinical Trials for teriflunomide

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

Sponsor	Phase
National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1/Phase 2
Novartis Pharmaceuticals	Phase 4
Oslo University Hospital	Phase 1/Phase 2

See all teriflunomide clinical trials

Generic filers with tentative approvals for TERIFLUNOMIDE

Applicant	Application No.	Strength	Dosage Form
		14MG	TABLET;ORAL
		14MG	TABLET;ORAL
		7MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for teriflunomide

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Paragraph IV (Patent) Challenges for TERIFLUNOMIDE

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 teriflunomide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Accord Hlthcare	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690-002	Jan 7, 2019	AB	RX	No	No
Amneal Pharms Co	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209613-001	Sep 28, 2018		DISCN	No	No
Alembic Pharms Ltd	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209572-002	Apr 19, 2019	AB	RX	No	No
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	AB	RX	Yes	No
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-001	Nov 15, 2018	AB	RX	No	No

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

EU/EMA Drug Approvals for teriflunomide

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

International Patents for teriflunomide

Country	Patent Number	Title	Estimated Expiration
South Korea	101547880
Russian Federation	2015151938	ТАБЛЕТИРУЕМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ
Honduras	2002000110	USO DE (Z) - 2 - CIANO - 3 - HIDROXI - BUTIL - 2 - ACIDO ENOICO (4' - TRIFLUOROMETIL FENILO) - AMIDA PARA EL TRATAMIENTO DE LA ESCLEROSIS MULTIPLE.
Russian Federation	2012115459	ТАБЛЕТИРУЮМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ
Japan	2013505213

Supplementary Protection Certificates for teriflunomide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	8/2014	Austria		PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
1381356	C 2014 006	Romania		PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826
1381356	92366	Luxembourg		PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
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