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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 202992


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NDA 202992 describes AUBAGIO, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AUBAGIO profile page.

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.
Summary for 202992
Tradename:AUBAGIO
Applicant:Sanofi Aventis Us
Ingredient:teriflunomide
Patents:3
Formulation / Manufacturing:see details
Pharmacology for NDA: 202992
Suppliers and Packaging for NDA: 202992
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUBAGIO teriflunomide TABLET;ORAL 202992 NDA Genzyme Corporation 58468-0210 58468-0210-1 1 BLISTER PACK in 1 CARTON (58468-0210-1) / 5 TABLET, FILM COATED in 1 BLISTER PACK
AUBAGIO teriflunomide TABLET;ORAL 202992 NDA Genzyme Corporation 58468-0210 58468-0210-3 1 BLISTER PACK in 1 CARTON (58468-0210-3) / 5 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7MG
Approval Date:Sep 12, 2012TE:ABRLD:Yes
Regulatory Exclusivity Expiration:Oct 30, 2024
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:Apr 30, 2024
Regulatory Exclusivity Use:REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
Patent:⤷  Try a TrialPatent Expiration:Mar 12, 2027Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 202992

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.