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 fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has one hundred and forty-eight patent family members in thirty-four countries.

One supplier is listed for this compound.

Summary for deutetrabenazine

International Patents:	148
US Patents:	15
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	15
Patent Applications:	3,861
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for deutetrabenazine
What excipients (inactive ingredients) are in deutetrabenazine?	deutetrabenazine excipients list
DailyMed Link:	deutetrabenazine at DailyMed

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

Generic Entry Dates for deutetrabenazine^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL
Generic Entry Dates for deutetrabenazine^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
Vanderbilt University Medical Center	Phase 2/Phase 3
Fundacion Huntington Puerto Rico	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 1/Phase 2

See all deutetrabenazine clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for deutetrabenazine

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

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

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Glossary

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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	208082-001	Apr 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
New Zealand	591615	BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2	⤷ Sign Up
Taiwan	201840317	Analogs of DEUTETRABENAZINE, their preparation and use	⤷ Sign Up
South Korea	102335744		⤷ Sign Up
Chile	2019002629	Análogos de deutetrabenazina, su preparación y uso.	⤷ Sign Up
Denmark	3265085		⤷ Sign Up
>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.