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Last Updated: September 21, 2020

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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 Ltd, Glenmark Pharms, Impax, MSN, Mylan, Sandoz Inc, Teva Pharms Usa, Watson Labs Teva, and Zydus Pharms, and is included in fourteen 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
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 3
EMD Serono Research & Development Institute, Inc.Phase 3
VU University Medical CenterN/A

See all teriflunomide clinical trials

Generic filers with tentative approvals for TERIFLUNOMIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial14MGTABLET;ORAL
  Start Trial  Start Trial14MGTABLET;ORAL
  Start Trial  Start 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 NDA Submissiondate
AUBAGIO TABLET;ORAL teriflunomide 202992 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
Teva Pharms Usa TERIFLUNOMIDE teriflunomide TABLET;ORAL 209700-001 Sep 4, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mylan TERIFLUNOMIDE teriflunomide TABLET;ORAL 209702-002 Feb 28, 2020 DISCN No No   Start Trial   Start Trial   Start Trial
Impax TERIFLUNOMIDE teriflunomide TABLET;ORAL 209677-001 Jun 17, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa TERIFLUNOMIDE teriflunomide TABLET;ORAL 209700-002 Sep 4, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd TERIFLUNOMIDE teriflunomide TABLET;ORAL 209638-001 Oct 26, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No   Start Trial   Start Trial   Start 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 202992-001 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for teriflunomide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 1490010-4 Sweden   Start Trial PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826
1381356 8/2014 Austria   Start Trial PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826
1381356 CA 2014 00005 Denmark   Start Trial PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826
1381356 C 2014 006 Romania   Start 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 PA2014004,C1381356 Lithuania   Start Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 486 Finland   Start Trial
1381356 PA2014004 Lithuania   Start Trial PRODUCT NAME: TERIFLUNOMIDUM; 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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