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Last Updated: April 20, 2024

Teriflunomide - Generic Drug Details

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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, Amneal Pharms Co, Apotex, Aurobindo Pharma, Biocon Pharma, Breckenridge, Glenmark Pharms, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in eighteen 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. Twenty-two suppliers are listed for this compound.

Summary for teriflunomide

International Patents:	79
US Patents:	3
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	22
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	51
Patent Applications:	4,509
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for teriflunomide
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

See drug prices for teriflunomide

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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Natco	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209555-001	May 15, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-001	Nov 15, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Teva Pharms Usa	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209700-001	Sep 4, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms Co	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209613-001	Sep 28, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Zydus Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209668-002	Nov 30, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209601-001	Nov 2, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for teriflunomide

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

EU/EMA Drug Approvals for teriflunomide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for teriflunomide

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Country	Patent Number	Title	Estimated Expiration
Mexico	336663	FORMULACIONES EN COMPRIMIDO DE LA (4'-TRIFLUOROMETILFENIL)AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON ESTABILIDAD MEJORADA. ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)- AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY.)	⤷ Try a Trial
Colombia	6511244	FORMULACIONES EN COMPRIMIDO DE LA ( ̈4 ́-TRIFLUOROMETILFENIL)AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON ESTABILIDAD MEJORADA	⤷ Try a Trial
Honduras	2002000110	USO DE (Z) - 2 - CIANO - 3 - HIDROXI - BUTIL - 2 - ACIDO ENOICO (4' - TRIFLUOROMETIL FENILO) - AMIDA PARA EL TRATAMIENTO DE LA ESCLEROSIS MULTIPLE.	⤷ Try a Trial
Hungary	E032963		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2011032929		⤷ Try a Trial
Dominican Republic	P2012000070	FORMULACIONES EN COMPRIMIDO DE LA (4-TRIFLUOROMETILFENIL) AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXIBUT-2-ENOICO CON ESTABILIDAD MEJORADA	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for teriflunomide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1381356	8/2014	Austria	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
1381356	132014902231965	Italy	⤷ Try a Trial	AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356	486	Finland	⤷ Try a Trial
1381356	122014000009	Germany	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	C300644	Netherlands	⤷ Try a Trial	PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	92366	Luxembourg	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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