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Generated: July 16, 2018

DrugPatentWatch Database Preview

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. 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. One supplier is 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
Generic Entry Opportunity Date for 202992
Generic Entry Date for 202992*:
Constraining patent/regulatory exclusivity:
Dosage::
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 N 58468-0210-1
AUBAGIO teriflunomide TABLET;ORAL 202992 NDA Genzyme Corp. 58468-0210 N 58468-0210-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7MG
Approval Date:Sep 12, 2012TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Sep 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
Patent:➤ Try a Free TrialPatent Expiration:Sep 14, 2030Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent 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 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-001 Sep 12, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AUBAGIO teriflunomide TABLET;ORAL 202992-002 Sep 12, 2012 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
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Fish and Richardson
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Cantor Fitzgerald
Farmers Insurance
Citi
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