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Last Updated: March 29, 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.

Drug Prices for TERIFLUNOMIDE

See drug prices for TERIFLUNOMIDE

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
⤷  Try a Trial⤷  Try a Trial14MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial7MGTABLET;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
Alembic TERIFLUNOMIDE teriflunomide TABLET;ORAL 209572-002 Apr 19, 2019 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
Aurobindo Pharma TERIFLUNOMIDE teriflunomide TABLET;ORAL 209638-001 Oct 26, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V TERIFLUNOMIDE teriflunomide TABLET;ORAL 209598-001 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 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

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

Country Patent Number Title Estimated Expiration
United Kingdom 0123571 ⤷  Try a Trial
Portugal 1381356 ⤷  Try a Trial
Ukraine 115979 ТАБЛЕТОВАНИЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНІЛ)АМІДУ (Z)-2-ЦІАНО-3-ГІДРОКСИБУТ-2-ЕНОЄВОЇ КИСЛОТИ З ПОЛІПШЕНОЮ СТІЙКІСТЮ ⤷  Try a Trial
Brazil 112012006184 formulações de comprimidos de ácido (z)-2-ciano-3-hidróxi-but-2-enoico-(4'-trifluormetilfenil)-amida com estabilidade aperfeiçoada ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TERIFLUNOMIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 C 2014 006 Romania ⤷  Try a Trial 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 486 Finland ⤷  Try a Trial
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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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