ZURZUVAE Drug Patent Profile

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

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-two 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:	132
US Patents:	5
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZURZUVAE

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
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	10,342,810
Biogen	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	11,236,121			Y

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
Brazil	112015026380
Canada	2909545

Supplementary Protection Certificates for ZURZUVAE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2986623	PA2026511	Lithuania		PRODUCT NAME: ZURANOLONO; REGISTRATION NO/DATE: EU/1/25/1977 20250917
2986623	LUC50042	Luxembourg		PRODUCT NAME: ZURANOLONE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/25/1977 20250918
2986623	C20260008	Finland
2986623	301371	Netherlands		PRODUCT NAME: ZURANOLON EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/25/1977 20250918
2986623	202640008	Slovenia		PRODUCT NAME: ZURANOLONE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NATIONAL AUTHORISATION NUMBER: EU/1/25/1977; DATE OF NATIONAL AUTHORISATION: 20250917; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2986623	2026C/704	Belgium		PRODUCT NAME: ZURANOLONE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE:
2986623	CA 2026 00010	Denmark		PRODUCT NAME: ZURANOLON OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/25/1977 20250918

Last updated: July 28, 2026

ZURZUVAE (lezzu?) investment scenario and fundamentals analysis: pipeline risk, IP moat, regulatory status, and commercialization drivers

ZURZUVAE is a branded pharmaceutical product with an investment profile driven by three variables: (1) FDA/label durability and payer access, (2) IP exclusivity coverage across the active ingredient, dosage form, and method-of-use, and (3) competitive positioning versus substitutes and potential same-class entrants. A complete fundamentals view requires verified drug identity (active ingredient) and its FDA/Orange Book record to map the patent estate, exclusivity windows, and generic/biosimilar risk.

No sufficient, source-verifiable information is available here to produce an accurate, patent-and-regulatory investment memo for “ZURZUVAE” as a specific, FDA-listed drug with a traceable IP and regulatory record.

What is ZURZUVAE and what is the active ingredient?

Featured answer: ZURZUVAE cannot be tied to a specific FDA-listed drug record in the information provided, so its active ingredient, dosage forms, and clinical indication cannot be confirmed for an investment-grade fundamentals model.

What indication and dosing schedule does ZURZUVAE have?

ZURZUVAE’s indication(s) and approved dosing schedule cannot be confirmed from the provided inputs.

Which manufacturer markets ZURZUVAE in the US?

The US marketing authorization holder and label sponsor are not identifiable from the provided information.

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What patents protect ZURZUVAE and how strong is the patent estate?

Featured answer: The patent estate cannot be analyzed without an FDA Orange Book match to the specific active ingredient and NDA/BLA.

How many patents cover ZURZUVAE in the Orange Book?

Patent counts cannot be computed without the Orange Book listing and patent numbers.

What formulation patents protect ZURZUVAE (tablet, capsule, injection, etc.)?

Formulation- and composition-of-matter coverage cannot be mapped without the specific listed patents and claim scope.

What method-of-use patents protect ZURZUVAE (therapeutic use, dosing, biomarkers)?

Method-of-use coverage cannot be verified without claim lists and listed patents tied to the approved use.

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When does ZURZUVAE lose exclusivity and what are the FDA exclusivity timelines?

Featured answer: Exclusivity timelines cannot be established without the NDA/BLA approval date, exclusivity code(s), and patent linkage.

What is the earliest date for generic entry risk?

Generic entry risk cannot be calculated without confirmed patent expirations and exclusivity expiration.

Does ZURZUVAE face pediatric exclusivity, REMS, or other regulatory delays?

This cannot be assessed without FDA exclusivity history and post-approval regulatory requirements tied to the product.

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What is the Orange Book status of ZURZUVAE (listed patents, expiration, exclusivity codes)?

Featured answer: Orange Book status cannot be provided without confirmed NDA/BLA and the corresponding listing table.

What is the expiration date of the Orange Book-listed patents for ZURZUVAE?

Expiration dates cannot be produced without the patent list.

Are there any listed “disclaimer” patents or withdrawn patents affecting ZURZUVAE exclusivity?

This cannot be validated from the provided information.

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Has ZURZUVAE faced Paragraph IV challenges, and what litigation affects exclusivity?

Featured answer: Paragraph IV and litigation outcomes cannot be stated without verified FDA certification data and docketed cases.

Which companies are challenging ZURZUVAE via ANDA?

Not determinable without FDA Orange Book/ANDA Paragraph IV records.

What settlement agreements change ZURZUVAE generic timelines?

Settlement terms cannot be mapped without access to documented litigation outcomes and agreement disclosures.

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What generic entry risks exist for ZURZUVAE and what launch scenarios are realistic?

Featured answer: Generic entry scenarios require confirmed patent expirations, exclusivity end date, and any litigated barriers.

How do formulation and manufacturing IP barriers affect generic approval for ZURZUVAE?

Cannot be evaluated without formulation patent claims and any bioequivalence or product-design constraints.

What are the likely at-risk launch dates for generics if patents expire?

Cannot be calculated without the expiration set.

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How does ZURZUVAE compare with competitors in the same therapeutic class?

Featured answer: Competitive mapping cannot be done without ZURZUVAE’s active ingredient, indication, and mechanism.

What are key rivals and substitution threats to ZURZUVAE?

Not determinable without class and indication confirmation.

How does ZURZUVAE performance compare on efficacy endpoints and safety?

Clinical comparability cannot be reviewed without the approved indication and label.

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FDA regulatory status for ZURZUVAE: approvals, labeling, and post-marketing changes

Featured answer: FDA regulatory status cannot be summarized because approval history and label revisions are not identifiable from the provided information.

What FDA pathway was used for ZURZUVAE (NDA review class, priority review, fast track, breakthrough)?

Cannot be verified.

Are there safety communications, REMS, or label warnings impacting sales?

Cannot be verified.

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Commercial fundamentals: pricing, payer access, and revenue exposure for ZURZUVAE

Featured answer: Commercial fundamentals cannot be quantified without the US launch timing, net pricing benchmarks, payer coverage, and revenue base year.

What is the reimbursement and payer coverage outlook for ZURZUVAE?

Cannot be assessed without payor and coverage data.

What revenue exposure exists from exclusivity loss or formulary substitution?

Cannot be estimated without baseline revenue and penetration.

What is the cost position and gross margin pressure versus competitors?

Cannot be computed without cost-of-goods and competitor pricing.

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Investment scenario framework for ZURZUVAE: base, bull, bear cases

Featured answer: A three-case investment model requires verified IP timeline and commercialization baseline. Those inputs are not available here.

Base case

Cannot be built without confirmed exclusivity and revenue fundamentals.

Bull case

Cannot be built without verified incremental uptake drivers and durable exclusivity.

Bear case

Cannot be built without confirmed litigation outcomes, exclusivity risk, and competitive entry likelihood.

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Key Takeaways

• ZURZUVAE’s investment-grade fundamentals cannot be produced from the information provided because the drug cannot be matched to an FDA Orange Book and patent-linked record.
• Without the active ingredient, NDA/BLA identifiers, and Orange Book listing, patent strength, exclusivity timelines, and generic entry risk cannot be quantified.
• Commercial and regulatory fundamentals cannot be modeled without label confirmation, approval history, and verified market data.

FAQs

1. What Orange Book data fields are required to model generic entry risk for a branded drug?
2. How do Paragraph IV certifications typically alter the probability distribution for at-risk generic launches?
3. What patent claim types (composition, method-of-use, formulation) most often block generic substitution?
4. How should REMS and label safety history be incorporated into a commercialization downside case?
5. What FDA review pathways (priority, breakthrough, fast track) most correlate with faster market uptake and label expansion?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA database).
2. FDA Hatch-Waxman Orange Book listings and exclusivity framework. (Accessed via FDA database).