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Last Updated: April 19, 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
Accord Hlthcare	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209690-001	Jan 7, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sola Pharms	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209677-001	Jun 17, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Msn	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209623-002	Apr 24, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Breckenridge	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209583-001	Sep 24, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209702-001	Feb 28, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Biocon Pharma	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209639-002	Mar 13, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Breckenridge	TERIFLUNOMIDE	teriflunomide	TABLET;ORAL	209583-002	Sep 24, 2021		DISCN	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
European Patent Office	1935416		⤷ Try a Trial
Japan	2013505213		⤷ Try a Trial
Morocco	33585	FORMULATIONS DE COMPRIMÉS DE (4'-TRIFLUOROMÉTHYLPHÉNYL)-AMIDE DE L'ACIDE (Z)-2-CYANO-3-HYDROXY-BUT-2-ÉNOÏQUE DE STABILITÉ AMÉLIORÉE	⤷ Try a Trial
Chile	2012000674	Composicion farmaceutica que comprende a) teriflunomida, b) un disgregante, c) un ligante, d) un lubricante y e) un diluyente; uso para el tratamiento de la sepsis, alegia, reacciones del injerto frente al receptor, reacciones del receptor, artritis reumatoide y lupus eritematoso sistemico, entre otros.	⤷ Try a Trial
Argentina	078383	FORMULACIONES EN COMPRIMIDO DE LA (4'-TRIFLUOROMETILFENIL ) AMIDA DEL ACIDO (Z) -2- CIANO-3- HIDROXIBUT-2-ENOICO CON MAYOR ESTABILIDAD	⤷ Try a Trial
Jordan	3327	تركيبات قرص تحتوي على المركب (Z)- 2- سيانو- 3- هيدروكسي- بيوت- 2- حمض ينويك- (4'- ثالث فلورو مثيل فنيل)- أميد بمستوى ثبات محسن (Z)-2-Cyano-3-hydroxy-but-2-enoic acid-(4’-trifluormethylphenyl)- amide tablet formulations with improved stability)	⤷ Try a Trial
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
>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	⤷ Try a Trial
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	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	CA 2014 00005	Denmark	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356	132014902231965	Italy	⤷ Try a Trial	AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356	PA2014004	Lithuania	⤷ Try a Trial	PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356	CR 2014 00005	Denmark	⤷ Try a Trial	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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.