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ZULRESSO Drug Profile

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

Zulresso is a drug marketed by Sage Therap and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-six patent family members in twenty-five countries.

The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.

US ANDA Litigation and Generic Entry Outlook for Zulresso

Zulresso will be eligible for patent challenges on June 17, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for ZULRESSO

International Patents:	66
US Patents:	7
Applicants:	1
NDAs:	1
Bulk Api Vendors:	43
Clinical Trials:	1
Patent Applications:	185
Drug Prices:	Drug price information for ZULRESSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZULRESSO
DailyMed Link:	ZULRESSO at DailyMed

See drug prices for ZULRESSO

Generic Entry Opportunity Date for ZULRESSO

NDA:

211371

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZULRESSO

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

Sponsor	Phase
Sage Therapeutics	Phase 4

See all ZULRESSO clinical trials

US Patents and Regulatory Information for ZULRESSO

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
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
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

International Patents for ZULRESSO

Country	Patent Number	Estimated Expiration
European Patent Office	3363430
Hungary	E046800
Japan	2018052991
Hong Kong	1204281
Japan	2015110671
South Korea	20110010742