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Last Updated: January 27, 2023

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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexanolone has one hundred and six patent family members in thirty countries.

One supplier is listed for this compound.

Summary for brexanolone
Recent Clinical Trials for brexanolone

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

SponsorPhase
Sage TherapeuticsPhase 2
Brigham and Women's HospitalPhase 4
Sage TherapeuticsPhase 1

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

International Patents for brexanolone

Country Patent Number Title Estimated Expiration
Japan 4923144 See Plans and Pricing
Brazil 112014018110 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2013112605 See Plans and Pricing
Japan 6838074 See Plans and Pricing
Canada 3017172 STEROIDES NEUROACTIFS, COMPOSITIONS, ET LEURS UTILISATIONS (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF) See Plans and Pricing
Japan 2018193377 ステロイドの抗痙攣活性 (ANTICONVULSANT ACTIVITY OF STEROIDS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
AstraZeneca
Mallinckrodt
Dow
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.