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 one branded drug marketed by Teva Branded Pharm and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has ninety-five patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for deutetrabenazine

International Patents:	95
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	20
Clinical Trials:	15
Patent Applications:	192
Formulation / Manufacturing:	see details
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

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	208082-003	Apr 3, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-003	Apr 3, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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
Japan	5616345		See Plans and Pricing
Eurasian Patent Organization	201992168	АНАЛОГИ ДЕУТЕТРАБЕНАЗИНА, ИХ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЕ	See Plans and Pricing
Singapore	11201706959T	METHODS FOR THE TREATMENT OF ABNORMAL INVOLUNTARY MOVEMENT DISORDERS	See Plans and Pricing
Australia	2018222896	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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