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AUBAGIO Drug 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.
US ANDA Litigation and Generic Entry Outlook for Aubagio
A generic version of AUBAGIO was approved as teriflunomide by GLENMARK PHARMS on November 15th, 2018.
Summary for AUBAGIO
International Patents: | 79 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 89 |
Clinical Trials: | 13 |
Patent Applications: | 2,313 |
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 |
---|---|
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Phase 3 |
EMD Serono Research & Development Institute, Inc. | Phase 3 |
Novartis Pharmaceuticals | Phase 3 |
Pharmacology for AUBAGIO
Drug Class | Pyrimidine Synthesis Inhibitor |
Mechanism of Action | Dihydroorotate Dehydrogenase Inhibitors |
Paragraph IV (Patent) Challenges for AUBAGIO
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
AUBAGIO | TABLET;ORAL | teriflunomide | 202992 | 2016-09-12 |
US Patents and Regulatory Information for AUBAGIO
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 | Start Trial | Start Trial | Start Trial | |||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 | 202992-002 | Sep 12, 2012 | Start Trial | Start Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | Start Trial | Start Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | Start Trial | Start Trial |
Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AUBAGIO
Country | Patent Number | Estimated Expiration |
---|---|---|
Spain | 2305287 | Start Trial |
Brazil | 112012006184 | Start Trial |
Taiwan | I522130 | Start Trial |
Japan | H05208908 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1381356 | 132014902231965 | Italy | Start Trial | AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826 |
1381356 | 122014000009 | Germany | Start Trial | PRODUCT NAME: TERIFLUNOMID, SEIN STEREOISOMER ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
1381356 | PA2014004 | Lithuania | Start Trial | PRODUCT NAME: TERIFLUNOMIDUM; REGISTRATION NO/DATE: EU/1/13/838/001-005 20130826 |
1381356 | CA 2014 00005 | Denmark | Start Trial | PRODUCT NAME: TERIFLUNOMID, DETS STEREOISOMER OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/13/838/001-005 20130826 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |