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Last Updated: October 27, 2021

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

Brexanolone has ninety-two patent family members in twenty-nine countries.

Summary for brexanolone

International Patents:	92
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	3
Patent Applications:	1,094
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brexanolone
What excipients (inactive ingredients) are in brexanolone?	brexanolone excipients list
DailyMed Link:	brexanolone at DailyMed

Recent Clinical Trials for brexanolone

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

Sponsor	Phase
Sage Therapeutics	Phase 4
Sage Therapeutics	Phase 3

See all brexanolone clinical trials

US Patents and Regulatory Information for brexanolone

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Glossary

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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	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	⤷ Try it Free	⤷ Try it Free	Y			⤷ Try it Free
>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

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Country	Patent Number	Estimated Expiration
Japan	2016501876	⤷ Try it Free
World Intellectual Property Organization (WIPO)	2009134347	⤷ Try it Free
Russian Federation	2018135079	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

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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.