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Last Updated: December 2, 2022

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 Pharms Ltd, Amneal Pharms Co, Apotex, Aurobindo Pharma, Breckenridge, Glenmark Pharms, MSN, Mylan, Sandoz Inc, Sola Pharms, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in fifteen 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. Four suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for teriflunomide

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institute of Neurological Disorders and Stroke (NINDS)Phase 1/Phase 2
Novartis PharmaceuticalsPhase 4
Oslo University HospitalPhase 1/Phase 2

See all teriflunomide clinical trials

Generic filers with tentative approvals for TERIFLUNOMIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing14MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing14MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing7MGTABLET;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
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

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 209690-002 Jan 7, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Amneal Pharms Co TERIFLUNOMIDE teriflunomide TABLET;ORAL 209613-001 Sep 28, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Alembic Pharms Ltd TERIFLUNOMIDE teriflunomide TABLET;ORAL 209572-002 Apr 19, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glenmark Pharms TERIFLUNOMIDE teriflunomide TABLET;ORAL 209663-001 Nov 15, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 See Plans and Pricing See Plans and Pricing
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for teriflunomide

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

International Patents for teriflunomide

Country Patent Number Title Estimated Expiration
South Korea 101547880 See Plans and Pricing
Russian Federation 2015151938 ТАБЛЕТИРУЕМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ See Plans and Pricing
Honduras 2002000110 USO DE (Z) - 2 - CIANO - 3 - HIDROXI - BUTIL - 2 - ACIDO ENOICO (4' - TRIFLUOROMETIL FENILO) - AMIDA PARA EL TRATAMIENTO DE LA ESCLEROSIS MULTIPLE. See Plans and Pricing
Russian Federation 2012115459 ТАБЛЕТИРУЮМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ See Plans and Pricing
Japan 2013505213 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for teriflunomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 122014000009 Germany See Plans and Pricing PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 8/2014 Austria See Plans and Pricing PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
1381356 C 2014 006 Romania See Plans and Pricing PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826
1381356 92366 Luxembourg See Plans and Pricing PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356 CR 2014 00005 Denmark See Plans and Pricing 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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