TETRABENAZINE - Generic Drug Details

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What are the generic drug sources for tetrabenazine and what is the scope of patent protection?

Tetrabenazine is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Ajanta Pharma Ltd, Apotex, Bionpharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Hikma, Mylan, Slate Run Pharma, Sun Pharm, and Bausch, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for tetrabenazine. Twelve suppliers are listed for this compound.

Sponsor	Phase
William Ondo, MD	Phase 4
The University of Texas Health Science Center, Houston	Phase 4
H. Lundbeck A/S	Phase 4

Sponsor

Phase

William Ondo, MD

Phase 4

The University of Texas Health Science Center, Houston

Phase 4

H. Lundbeck A/S

Phase 4

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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
Hetero Labs Ltd V	TETRABENAZINE	tetrabenazine	TABLET;ORAL	204574-002	Feb 3, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	TETRABENAZINE	tetrabenazine	TABLET;ORAL	209739-001	Apr 8, 2019		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bionpharma	TETRABENAZINE	tetrabenazine	TABLET;ORAL	208826-002	Dec 18, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	TETRABENAZINE	tetrabenazine	TABLET;ORAL	207682-002	Jan 31, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Fl Inc	TETRABENAZINE	tetrabenazine	TABLET;ORAL	206686-001	Jul 7, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	TETRABENAZINE	tetrabenazine	TABLET;ORAL	206129-002	Aug 17, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	134
Clinical Trials:	13
Patent Applications:	3,714
Drug Prices:	Drug price trends for TETRABENAZINE
What excipients (inactive ingredients) are in TETRABENAZINE?	TETRABENAZINE excipients list
DailyMed Link:	TETRABENAZINE at DailyMed

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors