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
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Teva	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209549-001	Jul 27, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209697-002	Apr 4, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sanofi Aventis Us	AUBAGIO	teriflunomide	TABLET;ORAL	202992-002	Sep 12, 2012	AB	RX	Yes	Yes	⤷ 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
Russian Federation	2015151938	ТАБЛЕТИРУЕМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ	⤷ Sign Up
Denmark	2477611		⤷ Sign Up
Cyprus	1119364		⤷ Sign Up
Israel	218492	פורמולציה של טבלייה עם (z)-2-ציאנו-3-הידרוקסי-באט-2 חומצה אנואית-(4' -טריפלואורומתילפניל)-אמיד ((z)-2-cyano-3-hydroxy-but-3-enoic acid-(4'-trifluoromethylphenyl)-amide tablet formulations with improved stability)	⤷ 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	C01381356/01	Switzerland	⤷ Sign Up	FORMER OWNER: AVENTISUB LLC, US
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
1381356	1490010-4	Sweden	⤷ Sign Up	PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356	2014/004	Ireland	⤷ Sign Up	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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