AUBAGIO Drug Patent Profile
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When do Aubagio patents expire, and what generic alternatives are available?
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-two 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.
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: | 12 |
Patent Applications: | 2,509 |
Formulation / Manufacturing: | see details |
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 |
---|---|
EMD Serono Research & Development Institute, Inc. | Phase 3 |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Phase 3 |
Novartis Pharmaceuticals | Phase 3 |
Pharmacology for AUBAGIO
Drug Class | Pyrimidine Synthesis Inhibitor |
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for AUBAGIO
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting AUBAGIO
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | 202992-001 | Sep 12, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Argentina | 033459 | USO DE (41-TRIFLUOROMETILFENIL)-AMIDA DEL ACIDO (Z)-2-CIANO-3-HIDROXI-BUT-2-ENOICO PARA EL TRATAMIENTO DE LA ESCLEROSIS MULTIPLE | ⤷ Try a Trial |
Taiwan | 201517935 | (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability | ⤷ Try a Trial |
Israel | 264912 | פורמולציות טבליה של -(z)2-ציאנו-3 -הידרוקסי-בוט-2 חומצה אנואית - ('4 טריפלואורומתילפניל) - אמיד עם יציבות משופרת ((z)-2-cyano-3-hydroxy-but-2-enoic acid-(4’-trifluormethylphenyl)-amide tablet formulations with improved stability) | ⤷ Try a Trial |
China | 104666238 | (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability | ⤷ Try a Trial |
Serbia | 56074 | (Z)-2-CIJANO-3-HIDROKSI-BUT-2-ENSKE KISELINE (4'-TRIFLUORMETILFENIL)-AMID FORMULACIJE TABLETA SA POBOLJŠANOM STABILNOŠĆU ((Z)-2-CYANO-3-HYDROXY-BUT-2-ENOIC ACID-(4'-TRIFLUORMETHYLPHENYL)-AMIDE TABLET FORMULATIONS WITH IMPROVED STABILITY) | ⤷ Try a Trial |
Russian Federation | 2015151938 | ТАБЛЕТИРУЕМЫЙ ПРЕПАРАТ (4'-ТРИФТОРМЕТИЛФЕНИЛ)АМИДА (Z)-2-ЦИАНО-3-ГИДРОКСИ-БУТ-2-ЕНОЕВОЙ КИСЛОТЫ С УЛУЧШЕННОЙ УСТОЙЧИВОСТЬЮ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1381356 | 2014C/008 | Belgium | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CESSION |
1381356 | PA2014004,C1381356 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
1381356 | C 2014 006 | Romania | ⤷ Try a Trial | 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 | C300644 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: TERIFLUONOMIDE, ITS STEROISOMER AND PHARAMCEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
1381356 | 132014902231965 | Italy | ⤷ Try a Trial | AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826 |
1381356 | 92366 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |