Tetrabenazine - Generic Drug Details

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What are the generic 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.

Summary for tetrabenazine

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

See drug prices for tetrabenazine

Recent Clinical Trials for tetrabenazine

Identify potential brand extensions & 505(b)(2) entrants

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

See all tetrabenazine clinical trials

Pharmacology for tetrabenazine

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

Medical Subject Heading (MeSH) Categories for tetrabenazine

Adrenergic Uptake Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for tetrabenazine

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for tetrabenazine

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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
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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