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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 216354


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NDA 216354 describes AUSTEDO XR, which is a drug marketed by Teva and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the AUSTEDO XR profile page.

The generic ingredient in AUSTEDO XR is deutetrabenazine. One supplier is listed for this compound. Additional details are available on the deutetrabenazine profile page.
Summary for 216354
Tradename:AUSTEDO XR
Applicant:Teva
Ingredient:deutetrabenazine
Patents:11
Suppliers and Packaging for NDA: 216354
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354 NDA Teva Neuroscience, Inc. 68546-470 68546-470-56 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-470-56)
AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354 NDA Teva Neuroscience, Inc. 68546-471 68546-471-56 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68546-471-56)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength6MG
Approval Date:Feb 17, 2023TE:RLD:Yes
Patent:10,959,996*PEDPatent Expiration:Sep 7, 2036Product Flag?Substance Flag?Delist Request?Y
Patent:11,179,386*PEDPatent Expiration:Sep 15, 2038Product Flag?Substance Flag?Delist Request?Y
Patent:11,311,488Patent Expiration:Jun 10, 2041Product Flag?YSubstance Flag?Delist Request?
Patented Use:A METHOD OF TREATING HUNTINGTON'S CHOREA

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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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