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. Four 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 GLENMARK PHARMS on November 15th, 2018.
Summary for AUBAGIO
| International Patents: | 79 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 97 |
| Clinical Trials: | 12 |
| Patent Applications: | 2,762 |
| 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 |
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
(Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for reducing the risk of an adverse teriflunomide and rosuvastatin interaction in multiple sclerosis patients
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting AUBAGIO
REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| >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 | See Plans and Pricing | See Plans and Pricing |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | See Plans and Pricing | See Plans and Pricing |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-002 | Sep 12, 2012 | See Plans and Pricing | See Plans and Pricing |
| Sanofi Aventis Us | AUBAGIO | teriflunomide | TABLET;ORAL | 202992-001 | Sep 12, 2012 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AUBAGIO
See the table below for patents covering AUBAGIO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 80149 | PHARMACEUTICAL COMPOSITIONS CONTAINING TOLUIDIDE DERIVATIVES AGAINST GRAFT-VERSUS-HOST DISEASES AND AUTOIMMUNE DISEASES | See Plans and Pricing |
| Australia | 6316786 | See Plans and Pricing | |
| Japan | H05208908 | CHRONIC PAIR HOST TRANSPLANTATION PIECE DISEASE REMEDY | See Plans and Pricing |
| Slovenia | 1381356 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AUBAGIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1381356 | 92366 | Luxembourg | See Plans and Pricing | PRODUCT NAME: TERIFLUNOMIDE,SON STEREOISOMERE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES |
| 1381356 | 132014902231965 | Italy | See Plans and Pricing | AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/838, 20130826;EU/1/13/838, 20130826 |
| 1381356 | SPC/GB14/011 | United Kingdom | See Plans and Pricing | PRODUCT NAME: TERIFLUNOMIDE, ITS STEREOISOMER OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/13/838/001-005 20130829 |
| 1381356 | 486 | Finland | See Plans and Pricing | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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