ZURZUVAE Drug Patent Profile

Which patents cover Zurzuvae, and what generic alternatives are available?

Zurzuvae is a drug marketed by Biogen and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and thirty-five patent family members in forty-one countries.

The generic ingredient in ZURZUVAE is zuranolone. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Zurzuvae

Zurzuvae will be eligible for patent challenges on October 31, 2027. 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 August 23, 2037. This may change due to patent challenges or generic licensing.

There have been two 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 ZURZUVAE

International Patents:	135
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Drug Prices:	Drug price information for ZURZUVAE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZURZUVAE
What excipients (inactive ingredients) are in ZURZUVAE?	ZURZUVAE excipients list
DailyMed Link:	ZURZUVAE at DailyMed

See drug prices for ZURZUVAE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZURZUVAE

Constraining patent/regulatory exclusivity:

11,236,121

NDA:

217369

Dosage:

CAPSULE;ORAL

^*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.

Pharmacology for ZURZUVAE

Drug Class	Neuroactive Steroid Gamma-Aminobutyric Acid A Receptor Positive Modulator
Mechanism of Action	GABA A Receptor Positive Modulators

US Patents and Regulatory Information for ZURZUVAE

ZURZUVAE is protected by five US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 11,236,121.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	9,512,165		Y	Y
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No

International Patents for ZURZUVAE

When does loss-of-exclusivity occur for ZURZUVAE?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Ecuador

Eurasian Patent Organization

European Patent Office

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Singapore

South Africa

South Korea

Taiwan

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 ZURZUVAE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2014256229
Australia	2018278844
Australia	2020256400
Australia	2022205157
Australia	2024278325

Supplementary Protection Certificates for ZURZUVAE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2986623	C20260008	Finland
2986623	CA 2026 00010	Denmark		PRODUCT NAME: ZURANOLON OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/25/1977 20250918
2986623	301371	Netherlands		PRODUCT NAME: ZURANOLON EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/25/1977 20250918
2986623	PA2026511	Lithuania		PRODUCT NAME: ZURANOLONO; REGISTRATION NO/DATE: EU/1/25/1977 20250917
2986623	2026C/704	Belgium		PRODUCT NAME: ZURANOLONE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: