Zuranolone - Generic Drug Details

What are the generic sources for zuranolone and what is the scope of freedom to operate?

Zuranolone is the generic ingredient in one branded drug marketed by Biogen Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zuranolone has one hundred and twenty-five patent family members in thirty-nine countries.

One supplier is listed for this compound.

Summary for zuranolone

International Patents:	125
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	2
Patent Applications:	291
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for zuranolone
What excipients (inactive ingredients) are in zuranolone?	zuranolone excipients list
DailyMed Link:	zuranolone at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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.

Recent Clinical Trials for zuranolone

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

Sponsor	Phase
Duke University	PHASE2
American Heart Association	PHASE2
Sage Therapeutics	Phase 1

See all zuranolone clinical trials

Pharmacology for zuranolone

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

Anatomical Therapeutic Chemical (ATC) Classes for zuranolone

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for zuranolone

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	217369-003	Oct 31, 2023		RX	Yes	Yes			Y	Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No

International Patents for zuranolone

Country	Patent Number	Title	Estimated Expiration
Israel	278487	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)
Cyprus	1121228
Japan	6710730

Supplementary Protection Certificates for zuranolone

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

Zuranolone Market Analysis and Financial Projection

Last updated: February 16, 2026

What Are the Market Dynamics for Zuranolone?

Zuranolone (SAGE-217), developed by Sage Therapeutics, is an oral neuroactive steroid. Its primary indication is major depressive disorder (MDD) and other psychiatric conditions such as postpartum depression (PPD) and possibly generalized anxiety disorder (GAD). Its mechanism involves modulation of GABA-A receptors, offering a novel approach to treat mood disorders.

Competitive Landscape

The market for neuroactive drugs targeting depression includes several key players:

• Brexanolone (Zulresso) by Sage Therapeutics, approved by the FDA for postpartum depression.
• Sintok Pharma's SAGE-324, an experimental drug targeting GABA-A receptor modulation.
• Other candidates from companies such as Biohaven and Janssen.

Current Market Size

The global depression treatment market was valued at approximately $11.9 billion in 2021, with expectations to grow at a compound annual growth rate (CAGR) of 2.9%, reaching $14.4 billion by 2028 (source: Fortune Business Insights [1]).

How Zuranolone Fits

As an oral alternative to intravenous brexanolone, Zuranolone aims to address unmet needs:

• Oral bioavailability allows outpatient treatment.
• Rapid onset of antidepressant effects.
• Short treatment duration compared to traditional SSRIs or SNRIs.

Regulatory and Clinical Development Status

• The FDA granted Breakthrough Therapy designation for Zuranolone in 2019 for PPD.
• Phase 3 trials for MDD completed with positive results; regulatory submissions are ongoing or planned.
• Pending approval expected around 2023–2024.

Market Drivers

• Increasing prevalence of depression globally: over 264 million people affected, with PPD affecting 10-15% of postpartum women.
• Rising demand for fast-acting antidepressants.
• Limitations of existing treatments, including delayed onset and side effects.

Market Limitations

• Pricing and reimbursement policies may constrain adoption.
• Competition from other fast-acting antidepressants, such as esketamine (Spravato).
• Long-term safety data still pending; may impact clinician confidence.

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What Is the Financial Trajectory for Zuranolone?

Revenue Projections

Initial Launch Forecasts:

• Sage Therapeutics projects Zuranolone could generate revenues exceeding $2 billion globally by 2028, assuming successful approval and commercialization.
• Early-stage projections suggest peak sales in the U.S. could reach $1.2 billion annually, capturing a significant share of the PPD and MDD markets.

Market Penetration Assumptions:

• First-year sales estimated at $200–300 million, derived from clinical trial success and regulatory approval speed.
• Compound annual growth rate (CAGR) of approximately 20–25% in the first five years post-launch, driven by expanded indications and increased adoption.

Cost Structure

• Development costs for Zuranolone are estimated at $600–800 million, including clinical trials and regulatory filings.
• Marketing, education, and distribution expenses are projected at 30–35% of revenue in the initial phase.

Profitability Outlook

• Sage Therapeutics aims to achieve profitability within 3–4 years post-launch.
• Margin targets include gross margins of approximately 70% and operating margins of 20–25%, contingent on market uptake and pricing policies.

Licensing and Patent Outlook

• Patents extend to at least 2030, with data exclusivity protections.
• Licensing agreements with strategic partners could influence revenue streams.

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What Are the Key Risks and Opportunities?

Risks:

• Regulatory delays or rejection.
• Market resistance to new neuroactive treatments.
• Competition from emerging therapies.
• Pricing pressures and reimbursement hurdles.

Opportunities:

• Expanding into additional indications such as GAD, bipolar disorder, or PTSD.
• Developing combined treatment protocols.
• Geographic expansion into emerging markets with high depression prevalence.

What Are the Key Takeaways?

• Zuranolone addresses unmet needs in depression therapy due to its oral route and rapid effects.
• It operates within a growing depression treatment market projected to reach $14.4 billion globally by 2028.
• Launch timelines point to approval around 2023–2024, with significant revenue potential contingent on clinical success and market acceptance.
• Competition includes existing fast-acting antidepressants and emerging neuroactive compounds.
• Financial forecasts suggest peak revenues in the billions, with profitability achievable within 4 years after approval, subject to market dynamics.

FAQs

1. When is Zuranolone expected to be approved?
Regulatory filings are expected around 2023–2024, with approvals possibly granted within a year thereafter.

2. How does Zuranolone differ from existing depression treatments?
It offers oral administration with rapid antidepressant effects, unlike traditional SSRIs or SNRIs, and is positioned as an alternative to injectable therapies like brexanolone.

3. What population segments are primary targets for Zuranolone?
Patients with postpartum depression, major depressive disorder, and potentially other mood and anxiety disorders.

4. What challenges could impact Zuranolone’s market success?
Regulatory hurdles, reimbursement policies, competition from other fast-acting drugs, and long-term safety data uncertainties.

5. What is the expected market penetration timeline?
Initial market penetration is expected within the first year post-approval, with steady growth over the following 3–5 years as indications expand and clinicians adopt the drug.

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Sources

[1] Fortune Business Insights. "Depression Treatment Market Size, Share & Industry Analysis." 2022.