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Brexanolone - Generic Drug Details

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What are the generic drug sources for brexanolone and what is the scope of patent protection?

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:	52
Clinical Trials:	5
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
University of California, Davis	Phase 2

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			Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes			Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes			Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes			Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes

International Patents for brexanolone

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	201000828
New Zealand	755699
European Patent Office	3363430
New Zealand	741406
China	104736158
South Africa	201805905