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Generated: November 15, 2018

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Details for New Drug Application (NDA): 208082

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NDA 208082 describes AUSTEDO, which is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from one supplier. There are five 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:5
Generic Entry Opportunity Date for 208082
Generic Entry Date for 208082*:
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.

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. 68546-170 68546-170-66 60 TABLET, COATED in 1 BOTTLE (68546-170-66)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength6MG
Approval Date:Apr 3, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Apr 3, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Apr 3, 2024
Regulatory Exclusivity Use:TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTON'S DISEASE
Regulatory Exclusivity Expiration:Aug 30, 2020
Regulatory Exclusivity Use:TREATMENT OF TARDIVE DYSKINESIA

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