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Last Updated: March 4, 2021

DrugPatentWatch Database Preview

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.

Summary for teriflunomide
Recent Clinical Trials for teriflunomide

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

SponsorPhase
Hoffmann-La RochePhase 3
EMD Serono Research & Development Institute, Inc.Phase 3
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 3

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
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
Amneal Pharms Co TERIFLUNOMIDE teriflunomide TABLET;ORAL 209613-002 Sep 28, 2018 DISCN No 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 202992-002 Sep 12, 2012   Start Trial   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 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 122014000009 Germany   Start Trial PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826
1381356 C300644 Netherlands   Start Trial PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY 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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