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Deutetrabenazine - Generic Drug Details

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What are the generic drug sources for deutetrabenazine and what is the scope of deutetrabenazine 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Deutetrabenazine has twenty-nine patent family members in eleven countries.

One supplier is listed for this compound.

Summary for deutetrabenazine

International Patents:	29
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	9
Clinical Trials:	6
Patent Applications:	8
DailyMed Link:	deutetrabenazine at DailyMed

Synonyms for deutetrabenazine

(3R,11bR)-3-(2-methylpropyl)-9,10-bis(trideuteriomethoxy)-1,3,4,6,7,11b-hexahydrobenzo[a]quinolizin-2-one

(3RS,11Brs)-9,10-di((2H3)methoxy)-3-(2-methylpropyl)-1,3,4,6,7,11b-hexahydro-2H-benzo(a)quinolizin-2-one

[2H6]-(+)-Tetrabenazine|||[2H6]-(+)- 9,10-Dimethoxy-1,3R,4,6,7,11bR-hexahydro-3-isobutyl-2H-benzo[a]quinolizin-2-one

1392826-25-3

2H-Benzo(a)quinolizin-2-one, 1,3,4,6,7,11b-hexahydro-9,10-di(methoxy-d3)-3-(2-methylpropyl)-, (3R,11bR)-rel-

Austedo

CHEMBL3137326

D10701

DB12161

Deutetrabenazine (USAN/INN)

Deutetrabenazine [USAN:INN]

Dutetrabenazine

GTPL8707

HY-B0590S

Ro 1-9569 D6

SCHEMBL13321841

SCHEMBL16227993

SCHEMBL16228022

SD 809

SD-809

SD809

Tetrabenazine D6

UNII-P341G6W9NB component MKJIEFSOBYUXJB-VFJJUKLQSA-N

UNII-P341G6W9NB component MKJIEFSOBYUXJB-WEZHFFAMSA-N

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	208082-001	Apr 3, 2017		RX	Yes	No			Y
Teva Branded Pharm	AUSTEDO	deutetrabenazine	TABLET;ORAL	208082-001	Apr 3, 2017		RX	Yes	No
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

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Non-Orange Book US Patents for deutetrabenazine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,346,800	Formulations pharmacokinetics of deuterated benzoquinoline inhibitors of vesicular monoamine transporter 2

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International Patents for deutetrabenazine

Country	Document Number	Estimated Expiration
Canada	2736409
European Patent Office	2897615
New Zealand	591615
Hong Kong	1212232