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Last Updated: August 13, 2020

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BUTISOL SODIUM Drug Profile

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When do Butisol Sodium patents expire, and when can generic versions of Butisol Sodium launch?

Butisol Sodium is a drug marketed by Meda Pharms and Mylan Speciality Lp and is included in two NDAs.

The generic ingredient in BUTISOL SODIUM is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.

Summary for BUTISOL SODIUM
Drug patent expirations by year for BUTISOL SODIUM

US Patents and Regulatory Information for BUTISOL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meda Pharms BUTISOL SODIUM butabarbital sodium ELIXIR;ORAL 085380-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-004 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-005 Approved Prior to Jan 1, 1982 DISCN 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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Serving leading biopharmaceutical companies globally:

Medtronic
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Baxter
Boehringer Ingelheim
AstraZeneca
McKesson

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