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Last Updated: May 26, 2022

AUBAGIO Drug Patent 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.

Drug patent expirations by year for AUBAGIO
Drug Prices for AUBAGIO

See drug prices for AUBAGIO

Recent Clinical Trials for AUBAGIO

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

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

See all AUBAGIO clinical trials

Paragraph IV (Patent) Challenges for AUBAGIO
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 AUBAGIO

AUBAGIO is protected by three US patents and two FDA Regulatory Exclusivities.

Patents protecting AUBAGIO

Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting AUBAGIO

REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: 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
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 AUBAGIO

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

International Patents for AUBAGIO

See the table below for patents covering AUBAGIO around the world.

Country Patent Number Title Estimated Expiration
Israel 80149 PHARMACEUTICAL COMPOSITIONS CONTAINING TOLUIDIDE DERIVATIVES AGAINST GRAFT-VERSUS-HOST DISEASES AND AUTOIMMUNE DISEASES See Plans and Pricing
Australia 6316786 See Plans and Pricing
Japan H05208908 CHRONIC PAIR HOST TRANSPLANTATION PIECE DISEASE REMEDY See Plans and Pricing
Slovenia 1381356 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AUBAGIO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1381356 92366 Luxembourg See Plans and Pricing PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES
1381356 132014902231965 Italy See Plans and Pricing AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826
1381356 SPC/GB14/011 United Kingdom See Plans and Pricing PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829
1381356 486 Finland See Plans and Pricing
>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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