Details for New Drug Application (NDA): 208082

NDA 208082 describes AUSTEDO, which is a drug marketed by Teva Branded Pharm and Teva and is included in two NDAs. It is available from one supplier. There are fifteen patents protecting this drug. Additional details are available on the AUSTEDO profile page.

The generic ingredient in AUSTEDO is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.

Summary for 208082

Tradename:	AUSTEDO
Applicant:	Teva Branded Pharm
Ingredient:	deutetrabenazine
Patents:	14

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208082

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.

Suppliers and Packaging for NDA: 208082

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AUSTEDO	deutetrabenazine	TABLET;ORAL	208082	NDA	Teva Neuroscience, Inc.	68546-170	68546-170-60	60 TABLET, COATED in 1 BOTTLE (68546-170-60)
AUSTEDO	deutetrabenazine	TABLET;ORAL	208082	NDA	Teva Neuroscience, Inc.	68546-171	68546-171-60	60 TABLET, COATED in 1 BOTTLE (68546-171-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	6MG
Approval Date:	Apr 3, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 24, 2024
Regulatory Exclusivity Use:	INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
Regulatory Exclusivity Expiration:	Dec 24, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Regulatory Exclusivity Expiration:	Oct 3, 2024
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY

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