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Last Updated: April 16, 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. There is one tentative approval 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

Generic filers with tentative approvals for TERIFLUNOMIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	14MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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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
Aurobindo Pharma	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209638-001	Oct 26, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209572-001	Apr 19, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Glenmark Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209663-002	Nov 15, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209555-001	May 15, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Natco	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209555-002	May 15, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd V	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209598-002	Mar 13, 2023	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
South Korea	20120089461	(Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY	⤷ Try a Trial
Montenegro	02765	(Z)-2-CIJAN0-3-HIDROKSI-BUT-2-ENSKE KISELINE (4'-TRIFLUORMETILFENIL) -AMID FORMULACIJE TABLETA SA POBOLJŠANOM STABILNOŠĆU ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY)	⤷ Try a Trial
European Patent Office	2477611	FORMULATIONS DE COMPRIMÉS D'ACIDE (Z)-2-CYANO-3-HYDROXY-BUT-2-ÉNOÏQUE-(4'-TRIFLUORMÉTHYLPHÉNYL)-AMIDE À STABILITÉ AMÉLIORÉE ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY)	⤷ Try a Trial
South Korea	101547880		⤷ Try a Trial
Portugal	1381356		⤷ Try a Trial
Spain	2305287		⤷ 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	2014C/008	Belgium	⤷ Try a Trial	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
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
1381356	C01381356/01	Switzerland	⤷ Try a Trial	FORMER OWNER: AVENTISUB LLC, US
1381356	14C0010	France	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	2014/004	Ireland	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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