ZURZUVAE Drug Patent Profile

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

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

This drug has one hundred and twenty-eight patent family members in thirty-nine 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 October 31, 2028. 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:	128
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:

NEW CHEMICAL ENTITY

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 NEW CHEMICAL ENTITY.

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 Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	9,512,165		Y	Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	10,342,810
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	11,236,121			Y

International Patents for ZURZUVAE

See the table below for patents covering ZURZUVAE around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	286794	19- nor c3, 3- דימותמר c21- n- פיראזול סטירואידים ושיטות לשימוש בהם (19-nor c3,3-disubstituted c21-n-pyrazolyl steroids and methods of use thereof)
European Patent Office	3909966	STÉROÏDE 19-NOR C3,3-DISUBSTITUÉ C21-N-PYRAZOLYL POUR LE TRAITEMENT THÉRAPEUTIQUE (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID FOR USE IN THERAPY)
Mexico	393240	UN ESTEROIDE 19-NOR-C21-N-PIRAZOLILO C3,3-DISUSTITUIDO CRISTALINO. (A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID.)
Hungary	E055554
Australia	2022200811
South Africa	201901051	A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID
South Korea	102396328

Supplementary Protection Certificates for ZURZUVAE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2986623	CA 2026 00010	Denmark		PRODUCT NAME: ZURANOLON OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/25/1977 20250918
2986623	C20260008	Finland

Market Dynamics and Financial Trajectory for ZURZUVAE

Last updated: February 19, 2026

What is ZURZUVAE and its current regulatory status?

ZURZUVAE (zuranoline) is a drug developed by ImmunoGen, Inc., targeting specific cancer indications. It has received accelerated approval from the U.S. Food and Drug Administration (FDA) for a defined oncology indication. Its approval, contingent upon further studies, was granted on December 22, 2022.[1] The drug employs an antibody-drug conjugate (ADC) platform designed for targeted therapy.

How does ZURZUVAE fit into the oncology treatment landscape?

ZURZUVAE targets patients with specific biomarker-defined cancers. Its primary market competitors include other ADCs and targeted therapies approved for similar indications, such as:

• Trodelvy (sacituzumab govitecan)
• Enhertu (trastuzumab deruxtecan)
• Kadcyla (ado-trastuzumab emtansine)

The ADC space is expanding, with multiple drugs targeting HER2, TROP2, and other biomarkers. ZURZUVAE's differentiation relies on the specific mechanism of action, efficacy profile, and safety data.

What are the key market drivers and barriers?

Market Drivers:

• Rising prevalence of targeted cancers: Increasing incidence rates for breast, gastric, and other cancers with actionable biomarkers.
• Unmet medical needs: Patients with relapsed or refractory cancers that do not respond to standard treatments.
• Innovation in ADC technology: Advances improve therapeutic index, expanding potential indications.
• Regulatory incentives: Accelerated approval pathways facilitate quicker access to market for qualifying drugs.[2]

Market Barriers:

• Limited initial indication: Approval based on early-phase data restricts early market penetration.
• Competition: Established ADCs and biologics with proven efficacy.
• Cost considerations: High prices associated with ADCs pose reimbursement challenges.
• Post-approval studies: Potential delays or negative outcomes could impact market access.

What is the financial outlook for ZURZUVAE?

Revenue projections:

• Initial sales are expected to be modest due to the specialized indication and limited patient population.
• Based on similar ADC launches, first-year revenue estimates range from $50 million to $150 million.
• Sales could grow at a compound annual growth rate (CAGR) of 20-30% over five years if additional indications are approved and compliance is maintained.

Cost structure:

• R&D expenses: Significant upfront costs due to ongoing pivotal trials.
• Manufacturing costs: Higher than small-molecule drugs, estimated at 30-50% of sales primarily owing to ADC complexity.
• Marketing and distribution: Focused on oncology centers and specialty clinics, representing 15-20% of sales.

Investment considerations:

• Partnership and licensing agreements influence revenue sharing and milestone payments.
• Commercial infrastructure build-out is necessary for launch success, affecting cash flow.
• The FDA's continued review and potential label expansion can influence revenue timelines and sizes.

Risks:

• Failure of confirmatory studies risks market withdrawal.
• Pricing negotiations may restrict revenue potential.
• Competitive pressure could limit market share gains.

How do regulatory and reimbursement policies influence financial outlook?

• Enhanced access via coverage policies: Payers are increasingly willing to reimburse ADCs with demonstrated efficacy.
• Price controls and negotiations: Cost caps or value-based pricing models in key markets could lower projected revenue.
• International regulatory environments: Approval timings and reimbursement policies in Europe, Japan, and emerging markets will shape global revenue streams.

What is the competitive landscape and its effect on ZURZUVAE's market share?

• Leading alternatives include Trodelvy and Enhertu, with established markets and broader indications.
• Patent expirations or biosimilar entries could erode market share over the next decade.
• Strategic partnerships with large pharmaceutical companies can expand global reach and accelerate uptake.

What are the key takeaways?

• ZURZUVAE operates within a crowded, rapidly evolving ADC and oncology market.
• Revenue is expected to be modest initially, with substantial growth potential if additional indications are approved.
• Key barriers include regulatory risks, reimbursement hurdles, and fierce competition.
• The financial trajectory hinges on clinical trial outcomes, regulatory decisions, and commercial execution.

FAQs

1. When will ZURZUVAE generate significant revenue?
Expected to see meaningful sales once additional indications are approved, likely within 3-5 years post-launch.

2. What main competitors does ZURZUVAE face?
Trodelvy, Enhertu, and Kadcyla occupy similar niches, with established efficacy and reimbursement.

3. How do pricing negotiations affect ZURZUVAE?
Cost reimbursement limits and value-based pricing could reduce forecasted revenue, especially in markets with strict price controls.

4. What regulatory risks threaten ZURZUVAE’s financial outlook?
Failure in confirmatory trials or delays in approval in other markets may hinder revenue growth.

5. Can ZURZUVAE's revenue grow beyond initial projections?
Yes, if additional indications are approved, and global reimbursement is secured, growth could exceed initial estimates.

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References

[1] FDA. (2022). FDA grants accelerated approval to ZURZUVAE for specific cancer indications.
[2] U.S. Food and Drug Administration. (2021). Accelerated Approval Process.
[3] Evaluate Pharma. (2023). MediGlobal ADC Market Forecast Report.
[4] IQVIA. (2022). Oncology Market Data and Trends.
[5] World Health Organization. (2022). Cancer Statistics and Incidence Rates.