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. Twenty-one suppliers are listed for this compound. Additional details are available on the teriflunomide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aubagio
A generic version of AUBAGIO was approved as teriflunomide by TEVA PHARMS USA on September 4th, 2018.
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Summary for AUBAGIO
| International Patents: | 79 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 15 |
| Patent Applications: | 2,509 |
| Drug Prices: | Drug price information for AUBAGIO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AUBAGIO |
| What excipients (inactive ingredients) are in AUBAGIO? | AUBAGIO excipients list |
| DailyMed Link: | AUBAGIO at DailyMed |
Recent Clinical Trials for AUBAGIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Peking University First Hospital | Phase 2 |
| China-Japan Friendship Hospital | Phase 2 |
| Beijing Hospital | Phase 2 |
Pharmacology for AUBAGIO
| Drug Class | Pyrimidine Synthesis Inhibitor |
| Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting AUBAGIO
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for AUBAGIO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Sanofi Winthrop Industrie | Aubagio | teriflunomide | EMEA/H/C/002514 AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). |
Authorised | no | no | no | 2013-08-26 | |
| Accord Healthcare S.L.U. | Teriflunomide Accord | teriflunomide | EMEA/H/C/005960 Teriflunomide Accord is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). |
Authorised | yes | no | no | 2022-11-09 | |
| Mylan Pharmaceuticals Limited | Teriflunomide Mylan | teriflunomide | EMEA/H/C/005962 Teriflunomide Mylan is indicated for the treatment of adult patients and paediatric patients aged 10 years and older (body weight > 40 kg) with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 of the SmPC for important information on the population for which efficacy has been established). |
Authorised | yes | no | no | 2022-11-09 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for AUBAGIO
See the table below for patents covering AUBAGIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ecuador | SP024244 | USO DE (Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID(4 ́-TRIFLUOROMETHYLPHENYL)-AMIDE PARA EL TRATAMIENTO DE LA ESCLEROSIS MÚLTIPLE | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2011032929 | ⤷ Sign Up | |
| Cyprus | 1119364 | ⤷ Sign Up | |
| Ireland | 61232 | Medicaments to combat chronic graft-versus-host diseases and to combat autoimmune diseases, in particular systemic lupus erythematosus | ⤷ Sign Up |
| Taiwan | I468190 | ⤷ Sign Up | |
| Argentina | 078383 | FORMULACIONES EN COMPRIMIDO DE LA (4'-TRIFLUOROMETILFENIL ) AMIDA DEL ACIDO (Z) -2- CIANO-3- HIDROXIBUT-2-ENOICO CON MAYOR ESTABILIDAD | ⤷ Sign Up |
| European Patent Office | 1935416 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1381356 | C 2014 006 | Romania | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMIDA, STEREOIZOMERUL SAU SI SARURILE FARMACEUTICACCEPTABILE ALEACESTEIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF NATIONAL AUTHORISATION: 20130826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/838/001, EU/1/13/838/002, EU/1/13/838/003, EU/1/13/838/004, EU/1/13/838/005; DATE OF FIRST AUTHORISATION IN EEA: 20130826 |
| 1381356 | SPC/GB14/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829 |
| 1381356 | 1490010-4 | Sweden | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMID, DESS STEREOISOMERER OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/13/838/001 20130826 |
| 1381356 | C300644 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| 1381356 | 14C0010 | France | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES.; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| 1381356 | PA2014004 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
| 1381356 | 8/2014 | Austria | ⤷ Sign Up | PRODUCT NAME: TERIFLUNOMID, SEINE STEREOISOMERE AND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/13/838 20130826 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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