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Last Updated: April 13, 2024

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 Teva and is included in two NDAs. It is available from one supplier. There are fourteen 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
Applicant:Teva Branded Pharm
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208082
Generic Entry Date for 208082*:
Constraining patent/regulatory exclusivity:

*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:RXDosage:TABLET;ORALStrength6MG
Approval Date:Apr 3, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 24, 2024
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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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 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.