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Generated: November 20, 2018

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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. 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 Corp. 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 Corp. 58468-0210 58468-0210-2 2 BLISTER PACK in 1 CARTON (58468-0210-2) > 14 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
Patent:➤ Sign UpPatent Expiration:Sep 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
Patent:➤ Sign UpPatent Expiration:Sep 14, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Feb 4, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE

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 202992-001 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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