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Last Updated: September 29, 2020

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Brexanolone - Generic Drug Details

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

Brexanolone is the generic ingredient in one branded drug marketed by Sage Therap and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexanolone has sixty-eight patent family members in twenty-five countries.

Summary for brexanolone
Recent Clinical Trials for brexanolone

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

SponsorPhase
Sage TherapeuticsPhase 4
Sage TherapeuticsPhase 3

See all brexanolone clinical trials

US Patents and Regulatory Information for brexanolone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Sage Therap ZULRESSO brexanolone SOLUTION;INTRAVENOUS 211371-001 Jun 17, 2019 RX Yes Yes   Start Trial   Start Trial Y   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:

Colorcon
Johnson and Johnson
AstraZeneca
Mallinckrodt
Dow
Baxter

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