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Serving leading biopharmaceutical companies globally:

Teva
Cantor Fitzgerald
Colorcon
Queensland Health
Cipla
Covington
Baxter
Cerilliant
Citi
UBS

Generated: December 12, 2017

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 eighteen 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:1
Applicant:1
Ingredient:1
Patents:3

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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength7MG
Approval Date:Sep 12, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 12, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:► SubscribePatent Expiration:Sep 12, 2026Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
Patent:► SubscribePatent Expiration:Sep 14, 2030Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 202992

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-002Sep 12, 2012► Subscribe► Subscribe
Sanofi Aventis UsAUBAGIOteriflunomideTABLET;ORAL202992-001Sep 12, 2012► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Argus Health
Deloitte
Merck
Chubb
Johnson and Johnson
AstraZeneca
Daiichi Sankyo
Moodys
Colorcon
Baxter

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