DEUTETRABENAZINE - Generic Drug Details

What are the generic drug 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.

Summary for DEUTETRABENAZINE

International Patents:	136
US Patents:	14
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	164
Clinical Trials:	15
Patent Applications:	3,861
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

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

Dosage:

TABLET;ORAL

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
University of Pennsylvania	Phase 1/Phase 2

See all DEUTETRABENAZINE clinical trials

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	AUSTEDO XR	deutetrabenazine	TABLET, EXTENDED RELEASE;ORAL	216354-001	Feb 17, 2023		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No					Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-002	Apr 3, 2017		RX	Yes	No					Y

International Patents for DEUTETRABENAZINE

Country	Patent Number	Title	Estimated Expiration
Denmark	3265085
Israel	269132	אנאלוגים של דאוטטרבנזין, הכנתם ושימוש בהם (Analogs of deutetrabenazine, their preparation and use)
European Patent Office	2897615	PHARMACOCINÉTIQUES DE FORMULATIONS D'INHIBITEURS DE BENZOQUINOLINE DEUTÉRÉ DU TRANSPORTEUR 2 DE MONOAMINE VÉSICULAIRE (FORMULATIONS PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VESICULAR MONOAMINE TRANSPORTER 2)
Japan	2019059784	小胞モノアミン輸送体２の重水素化ベンゾキノリン阻害剤の製剤薬物動態 (PHARMACOKINETICS OF DEUTERATED BENZOQUINOLINE INHIBITORS OF VASCULAR MONOAMINE TRANSPORTER 2)