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Last Updated: July 26, 2021

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Butabarbital sodium - Generic Drug Details

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What are the generic sources for butabarbital sodium and what is the scope of patent protection?

Butabarbital sodium is the generic ingredient in ten branded drugs marketed by Medpointe Pharm Hlc, Alpharma Us Pharms, Wockhardt, Lannett, Meda Pharms, Halsey, Bundy, Sandoz, Solvay, Teva, Watson Labs, Whiteworth Town Plsn, Mylan Speciality Lp, Hikma, Ivax Sub Teva Pharms, and Marshall Pharma, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for butabarbital sodium.

Recent Clinical Trials for butabarbital sodium

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SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all butabarbital sodium clinical trials

US Patents and Regulatory Information for butabarbital sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Halsey SARISOL NO. 2 butabarbital sodium TABLET;ORAL 084719-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett BUTALAN butabarbital sodium ELIXIR;ORAL 085880-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Teva BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 088631-001 May 1, 1985 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Harvard Business School
Colorcon
Merck
Boehringer Ingelheim
Dow

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