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Last Updated: August 8, 2020

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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, Apotex, Bionpharma Inc, Dr Reddys, Hetero Labs Ltd V, Hikma, Lupin Ltd, Mylan, Piramal Hlthcare Uk, Sun Pharm, and Valeant Pharms North, and is included in eleven 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.

Drug Prices for tetrabenazine

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Recent Clinical Trials for tetrabenazine

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

Kirk A. FreyPhase 1
Adeptio PharmaceuticalsPhase 1
Dr. Reddy's Laboratories LimitedPhase 1

See all tetrabenazine clinical trials

Pharmacology for tetrabenazine
Medical Subject Heading (MeSH) Categories for tetrabenazine

US Patents and Regulatory Information for tetrabenazine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd TETRABENAZINE tetrabenazine TABLET;ORAL 210544-001 Apr 20, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TETRABENAZINE tetrabenazine TABLET;ORAL 207682-002 Jan 31, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma TETRABENAZINE tetrabenazine TABLET;ORAL 209739-001 Apr 8, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys TETRABENAZINE tetrabenazine TABLET;ORAL 209284-001 Jan 8, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Labs Fl Inc TETRABENAZINE tetrabenazine TABLET;ORAL 206686-001 Jul 7, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
>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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