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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. Additional details are available on the AUBAGIO profile page.

The generic ingredient in AUBAGIO is teriflunomide. There are seventeen 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 NDA: 202992

Tradename:
AUBAGIO
Applicant:
Sanofi Aventis Us
Ingredient:
teriflunomide
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:No
Patent:8,802,735Patent Expiration:Sep 14, 2030Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Sep 12, 2017
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:6,794,410Patent Expiration:Apr 15, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

Expired Orange Book Patents for NDA: 202992

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-001Sep 12, 20125,459,163► subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 20125,679,709► subscribe
Sanofi Aventis Us
AUBAGIO
teriflunomide
TABLET;ORAL202992-002Sep 12, 20125,459,163► subscribe
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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 verifification 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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