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Last Updated: March 3, 2021

DrugPatentWatch Database Preview

AUBAGIO Drug Profile

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When do Aubagio patents expire, and when can generic versions of Aubagio launch?

Aubagio is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-nine patent family members in forty-six countries.

The generic ingredient in AUBAGIO is teriflunomide. There are nineteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.

US ANDA Litigation and Generic Entry Outlook for Aubagio

A generic version of AUBAGIO was approved as teriflunomide by GLENMARK PHARMS on November 15th, 2018.

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Drug patent expirations by year for AUBAGIO
Drug Prices for AUBAGIO

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Recent Clinical Trials for AUBAGIO

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SponsorPhase
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyPhase 3
EMD Serono Research & Development Institute, Inc.Phase 3
Novartis PharmaceuticalsPhase 3

See all AUBAGIO clinical trials

Pharmacology for AUBAGIO
Paragraph IV (Patent) Challenges for AUBAGIO
Tradename Dosage Ingredient NDA Submissiondate
AUBAGIO TABLET;ORAL teriflunomide 202992 2016-09-12

US Patents and Regulatory Information for AUBAGIO

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 202992-001 Sep 12, 2012 AB RX Yes 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   Start Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes 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 Y   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 AUBAGIO

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

Supplementary Protection Certificates for AUBAGIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 132014902231965 Italy   Start Trial AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 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 PA2014004 Lithuania   Start Trial PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
AstraZeneca
Medtronic
Express Scripts
Harvard Business School

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