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. Aubagio's patents have been open to challenges since 31 October, 2023. 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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9186346 (Pediatric) | Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients |
Aug, 2034
(9 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 |
|
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 |
| US8802735 | (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability |
Sep, 2030
(5 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 |
| US6794410 | Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis |
Sep, 2026
(1 year, 9 months from now) | Active |
| US5679709 | Medicaments to combat autoimmune diseases |
Oct, 2014
(10 years ago) |
Expired
|
| US5459163 | Medicament to combat autoimmune diseases |
Oct, 2012
(12 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Aubagio's patents.
Latest Legal Activities on Aubagio's Patents
Given below is the list of recent legal activities going on the following patents of Aubagio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Jan, 2022 | US8802735 |
| Post Issue Communication - Certificate of Correction | 29 Jun, 2018 | US8802735 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Feb, 2018 | US8802735 |
| Patent Term Extension Certificate Critical | 13 Dec, 2016 | US6794410 |
| Notice of Final Determination -Eligible | 09 Aug, 2016 | US6794410 |
| Mail PUB other miscellaneous communication to applicant | 24 Mar, 2016 | US8802735 |
| PUB Other miscellaneous communication to applicant | 22 Mar, 2016 | US8802735 |
| Post Issue Communication - Certificate of Correction | 21 Mar, 2016 | US8802735 |
| Mail Certificate of Correction Memo | 18 Mar, 2016 | US8802735 |
| Certificate of Correction Memo | 17 Mar, 2016 | US8802735 |
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. All of its exclusivities have expired 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
Approval Date:
Aubagio was approved by FDA for market use on 12 September, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. 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 |
|---|---|---|---|
| 14MG | TABLET | Prescription | ORAL |
| 7MG | TABLET | Prescription | ORAL |