Aubagio Patent Expiration

Aubagio is a drug owned by Sanofi Aventis Us Llc. It is protected by 8 US drug patents filed from 2013 to 2021. Out of these, 6 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 04, 2034. Details of Aubagio's patents and their expiration are given in the table below.


Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5459163 Medicament to combat autoimmune diseases
Oct, 2012

(11 years ago)

Expired
US5679709 Medicaments to combat autoimmune diseases
Oct, 2014

(9 years ago)

Expired
US6794410 Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
Sep, 2026

(2 years from now)

Active
US6794410

(Pediatric)

Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
Mar, 2027

(2 years from now)

Active
US8802735 (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Sep, 2030

(6 years from now)

Active
US8802735

(Pediatric)

(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Mar, 2031

(6 years from now)

Active
US9186346 Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Feb, 2034

(9 years from now)

Active
US9186346

(Pediatric)

Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Aug, 2034

(10 years from now)

Active


FDA has granted several exclusivities to Aubagio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Aubagio, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Aubagio.

Exclusivity Information

Aubagio holds 3 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2024. Details of Aubagio's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Sep 12, 2017
M(M-61) Apr 30, 2024
Pediatric Exclusivity(PED) Oct 30, 2024

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Several oppositions have been filed on Aubagio's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Aubagio's generic, the next section provides detailed information on ongoing and past EP oppositions related to Aubagio patents.

Aubagio's oppositions filed in EPO

Aubagio has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 19, 2017, by Cooke, Richard. This opposition was filed on patent number EP10752585A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP10752585A Jan, 2018 Pentafarma Sociedade Técnico-Medicinal S.A. Revoked
EP10752585A Dec, 2017 Wuesthoff & Wuesthoff Patentanwälte PartG mbB Revoked
EP10752585A Dec, 2017 Cooke, Richard Revoked


US patents provide insights into the exclusivity only within the United States, but Aubagio is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Aubagio's family patents as well as insights into ongoing legal events on those patents.

Aubagio's family patents

Aubagio has patent protection in a total of 47 countries. It's US patent count contributes only to 18.5% of its total global patent coverage. 14 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Aubagio.

Family Patents

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Generic Launch

Generic Release Date:

Aubagio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 04, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Aubagio Generics:

Teriflunomide is the generic name for the brand Aubagio. 18 different companies have already filed for the generic of Aubagio, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aubagio's generic

How can I launch a generic of Aubagio before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Aubagio's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aubagio's sponsor is invalid, unenforceable, or will not be infringed by your generic product.

Given below are the details of the already filed Para IV certificates on Aubagio -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
7 mg and 14 mg 12 Sep, 2016 21 27 Jul, 2018 04 Feb, 2034 Eligible




About Aubagio

Aubagio is a drug owned by Sanofi Aventis Us Llc. It is used for treating patients with relapsing forms of multiple sclerosis. Aubagio uses Teriflunomide as an active ingredient. Aubagio was launched by Sanofi Aventis Us in 2012.

Market Authorisation Date:

Aubagio was approved by FDA for market use on 12 September, 2012.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Aubagio is 12 September, 2012, its NCE-1 date is estimated to be 31 October, 2023

Active Ingredient:

Aubagio uses Teriflunomide as the active ingredient. Check out other Drugs and Companies using Teriflunomide ingredient

Treatment:

Aubagio is used for treating patients with relapsing forms of multiple sclerosis.

Dosage:

Aubagio is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
7MG TABLET Prescription ORAL
14MG TABLET Prescription ORAL