Tetrabenazine - Generic Drug Details

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What are the generic drug sources for tetrabenazine and what is the scope of freedom to operate?

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

Sponsor

Phase

H. Lundbeck A/S

Phase 4

William Ondo, MD

Phase 4

The University of Texas Health Science Center, Houston

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
Dr Reddys	TETRABENAZINE	tetrabenazine	TABLET;ORAL	209284-002	Jan 8, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	XENAZINE	tetrabenazine	TABLET;ORAL	021894-002	Aug 15, 2008	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	XENAZINE	tetrabenazine	TABLET;ORAL	021894-001	Aug 15, 2008	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apotex	TETRABENAZINE	tetrabenazine	TABLET;ORAL	206093-002	Mar 17, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd V	TETRABENAZINE	tetrabenazine	TABLET;ORAL	204574-001	Feb 3, 2016	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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
Formulation / Manufacturing:	see details
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