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 Speclt, Hetero Labs Ltd V, MSN, Mylan, Natco, Sandoz, Sola Pharms, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in nineteen 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-one suppliers are listed for this compound.

Summary for TERIFLUNOMIDE

International Patents:	79
US Patents:	3
Tradenames:	2
Applicants:	19
NDAs:	19
Drug Master File Entries:	19
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	118
Clinical Trials:	55
Patent Applications:	4,125
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
Beijing Friendship Hospital	Phase 2
Peking University Third Hospital	Phase 2
Chinese PLA General Hospital	Phase 2

See all TERIFLUNOMIDE clinical trials

Pharmacology for TERIFLUNOMIDE

Drug Class	Pyrimidine Synthesis Inhibitor
Mechanism of Action	Dihydroorotate Dehydrogenase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TERIFLUNOMIDE

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

L04AK	Dihydroorotate dehydrogenase (DHODH) inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

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
Accord Hlthcare	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690-001	Jan 7, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209668-002	Nov 30, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sola Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209677-001	Jun 17, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Msn	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209623-001	Apr 24, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209598-002	Mar 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209598-001	Mar 13, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	202992-002	Sep 12, 2012	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-001	Sep 12, 2012	⤷ Sign Up	⤷ Sign Up
>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
Taiwan	I522130		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2011032929		⤷ Sign Up
European Patent Office	1935416		⤷ Sign Up
New Zealand	598744	(Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY	⤷ Sign Up
Russian Federation	2015151938	ТАБЛЕТИРУЕМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ	⤷ Sign Up
Spain	2625731		⤷ Sign Up
>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	486	Finland	⤷ Sign Up
1381356	132014902231965	Italy	⤷ Sign Up	AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356	92366	Luxembourg	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356	SPC/GB14/011	United Kingdom	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
1381356	2014C/008	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION
1381356	CR 2014 00005	Denmark	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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