ZULRESSO Drug Patent Profile

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 eight patents protecting this drug.

This drug has one hundred patent family members in twenty-nine countries.

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

DrugPatentWatch^® 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 six 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:	100
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	7
Patent Applications:	690
Drug Prices:	Drug price information for ZULRESSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZULRESSO
What excipients (inactive ingredients) are in ZULRESSO?	ZULRESSO excipients list
DailyMed Link:	ZULRESSO at DailyMed

See drug prices for ZULRESSO

DrugPatentWatch^® Estimated 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
Brigham and Women's Hospital	Phase 4
Sage Therapeutics	Phase 1
Donald Jeffrey Newport	Phase 4

See all ZULRESSO clinical trials

US Patents and Regulatory Information for ZULRESSO

ZULRESSO is protected by eight US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZULRESSO

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

International Patents for ZULRESSO

When does loss-of-exclusivity occur for ZULRESSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ZULRESSO around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	3017172	STEROIDES NEUROACTIFS, COMPOSITIONS, ET LEURS UTILISATIONS (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF)
New Zealand	755699	Neuroactive steroid formulations and methods of treating cns disorders
Serbia	59734	FORMULACIJE NEUROAKTIVNOG STEROIDA KOJE UKLJUČUJU KOMPLEKS ALOPREGNANOLONA I SULFOBUTIL ETAR BETA-CIKLODEKSTRINA (NEUROACTIVE STEROID FORMULATIONS COMPRISING A COMPLEX OF ALLOPREGNANOLONE AND SULFOBUTYL ETHER BETA-CYCLODEXTRIN)
Mexico	352459	COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.)
Japan	2018076341	向神経活性ステロイド製剤およびＣＮＳ障害の処置方法 (NEUROACTIVE STEROID FORMULATION AND METHODS FOR TREATING CNS DISORDERS)