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Last Updated: March 4, 2024

Deutetrabenazine - Generic Drug Details


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What are the generic sources for deutetrabenazine and what is the scope of freedom to operate?

Deutetrabenazine is the generic ingredient in two branded drugs marketed by Teva and Teva Branded Pharm, and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has one hundred and thirty-six patent family members in thirty-three countries.

One supplier is listed for this compound.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for deutetrabenazine
Generic Entry Dates for deutetrabenazine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL
Generic Entry Dates for deutetrabenazine*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.

Recent Clinical Trials for deutetrabenazine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Vanderbilt University Medical CenterPhase 2/Phase 3
Fundacion Huntington Puerto RicoPhase 1
Teva Branded Pharmaceutical Products, R&D Inc.Phase 1/Phase 2

See all deutetrabenazine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for deutetrabenazine
Paragraph IV (Patent) Challenges for DEUTETRABENAZINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
AUSTEDO Tablets deutetrabenazine 6 mg, 9 mg and 12 mg 208082 2 2021-04-05

US Patents and Regulatory Information for deutetrabenazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva AUSTEDO XR deutetrabenazine TABLET, EXTENDED RELEASE;ORAL 216354-002 Feb 17, 2023 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-001 Apr 3, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Teva Branded Pharm AUSTEDO deutetrabenazine TABLET;ORAL 208082-003 Apr 3, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for deutetrabenazine

Country Patent Number Title Estimated Expiration
Japan 7419571 ⤷  Try a Trial
Australia 2016229949 ⤷  Try a Trial
Denmark 3061760 ⤷  Try a Trial
Chile 2022003512 Formas farmacéuticas osmóticas que comprenden deutetrabenazina y métodos de uso de las mismas ⤷  Try a Trial
Israel 288712 Methods for the treatment of abnormal involuntary movement disorders ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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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.