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-one patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for zuranolone

International Patents:	121
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
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				Y
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No

International Patents for zuranolone

Country	Patent Number	Title	Estimated Expiration
South Korea	102614507
Japan	7668850
Denmark	3909966
Canada	2909545	19-NOR-C21-N-PYRAZOLYL-STEROIDES C3,3-DISUBSTITUES ET PROCEDES D'UTILISATION DE CEUX-CI (19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF)

Market Dynamics and Financial Trajectory for Zuranolone

Last updated: July 31, 2025

Introduction

Zuranolone (market name: SAGE-217) is an investigational neuroactive steroid developed by Sage Therapeutics, predominantly targeting indications such as major depressive disorder (MDD) and postpartum depression (PPD). As a positive allosteric modulator of GABA_A receptors, zuranolone operates within a promising therapeutic class, offering rapid onset and sustained remission of depressive symptoms. Given its early-stage approval status, analyzing its market dynamics and projected financial trajectory involves evaluating regulatory milestones, competitive landscape, market demand, and reimbursement considerations.

Regulatory Landscape and Clinical Development

Zuranolone's clinical development has progressed through multiple phases. The drug garnered rapid attention following positive Phase 3 trial results demonstrating significant reductions in depressive symptoms in PPD and MDD populations [1]. Regulatory authorities, notably the U.S. Food and Drug Administration (FDA), have granted zuranolone designations, including Breakthrough Therapy status for certain indications, expediting review processes.

The approval of a drug like zuranolone depends on successful completion of pivotal trials, favorable safety profiles, and demonstrated differentiation from existing therapies. The drug's potential for fast-acting relief in depressive disorders positions it uniquely within the psychiatric market, which historically has relied on therapies with delayed onset.

Market Demand and Therapeutic Opportunities

Depression and Postpartum Depression Market Size

The global depression therapeutics market was valued at approximately $11 billion in 2020 and is projected to grow at a compound annual growth rate (CAGR) of around 3-5% [2]. PPD affects approximately 10-15% of new mothers, representing a significant unmet medical need, with over 20 million women globally affected annually [3].

Unmet Medical Needs and Differentiators

Current antidepressants, including SSRIs and SNRIs, typically require several weeks to exert full effects and may have tolerability issues. Zuranolone's rapid action—within days—addresses a critical gap, especially for acute episodes. Its oral administration enhances patient compliance over intravenous or intramuscular options.

Market Segmentation and Target Populations

The primary markets include:

• Major Depressive Disorder (MDD): A pervasive condition affecting over 264 million globally [4], with a substantial subset demanding rapid remission therapies.
• Postpartum Depression (PPD): A specific, vulnerable cohort, with high relapse rates and limited targeted pharmacological options.

The expansion beyond these indications, such as Generalized Anxiety Disorder or other neuropsychiatric conditions, could further increase its market potential.

Competitive Landscape

Existing and Emerging Treatments

Zuranolone enters a space populated by fast-acting neurosteroids and GABA_A receptor modulators, including brexanolone (Zulresso) by Sage and other agents like zuranolone’s potential competitors under development. Brexanolone, administered intravenously, demonstrated efficacy in PPD but is limited by its administration route and cost, creating a niche for oral zuranolone.

Differentiation Strategies

Key differentiators for zuranolone include:

• Oral bioavailability versus injection-based therapies
• Rapid symptom reduction
• Favorable safety profile
• Ease of use and broader accessibility

Patent and Exclusivity Considerations

Patent protection is vital. Zuranolone’s initial patents extend into the late-2020s or early-2030s, securing exclusivity during critical commercial windows. Lifeline for future market protection hinges on generating additional formulations or gaining regulatory exclusivity.

Financial Trajectory

Revenue Projections

Based on clinical trial success, regulatory approval timelines, and market penetration, projections vary:

• Short-term (1-3 years post-approval): Revenue may be modest, driven by initial launches targeting PPD, with estimates around $100-300 million, influenced by initial adoption and payor coverage.
• Medium-term (3-5 years): As indications expand and prescriber awareness increases, revenues could reach $1 billion globally, assuming competitive advantage and reimbursement support.
• Long-term (beyond 5 years): Sustained growth depends on broader indication approval, global market expansion, and potential label expansions, with some analysts estimating up to $2-3 billion annually in peak sales.

Cost Considerations

Development, manufacturing, and commercialization costs are significant, especially given the need for extensive clinical trials and regulatory compliance. Sage Therapeutics’ R&D expenses peaked during clinical phases but are expected to decline upon commercial launch, improving margins.

Pricing Strategy and Reimbursement Landscape

Pricing for zuranolone will likely position it as a premium therapy due to its rapidity and oral convenience. Reimbursement negotiations with payers will influence net revenues, emphasizing the importance of demonstrating cost-effectiveness and clinical benefit over existing standards.

Partnerships and Licensing Agreements

Strategic collaborations with pharmaceutical firms or biotech companies can accelerate market access, sharing costs and risks, and expanding geographic reach.

Market Risks and Challenges

Factors that could impact financial performance include:

• Regulatory hurdles: Delays or rejection can impede or reduce market entry.
• Competitive pressures: New therapies with similar or superior profiles could erode market share.
• Pricing pressures: Payer resistance to premium pricing may limit revenue potential.
• Market acceptance: Prescriber adoption hinges on perceived efficacy and safety profile.

Future Outlook and Investment Considerations

Investors and stakeholders should monitor:

• Progression of regulatory filings and approvals
• Post-marketing studies confirming long-term safety and efficacy
• Competitive dynamics within neurosteroid and GABAergic modulators
• Expansion into new indications and markets

Given its pioneering profile and high unmet needs addressing, zuranolone’s financial trajectory appears promising, contingent on successful commercialization and sustained market differentiation.

Key Takeaways

• Significant unmet medical need exists for rapid-acting antidepressants in depression and PPD, positioning zuranolone favorably.
• Regulatory milestones, especially FDA approval, will serve as crucial catalysts for market access and revenue generation.
• Oral administration offers a competitive advantage over injectable therapies, broadening market potential.
• Projected revenues can reach into billions annually if zuranolone achieves broad indication approval and market penetration.
• Pricing, reimbursement, and competitive landscape will critically influence the drug’s financial success.

FAQs

1. When is zuranolone expected to gain FDA approval?
Based on current clinical data and regulatory interactions, Zurabanone’s approval is anticipated within the next 12-24 months, contingent upon submission timing and agency review processes [1].

2. How does zuranolone differ from existing depression treatments?
It offers a rapid onset of action—within days—via oral administration, contrasting with traditional antidepressants requiring weeks. Its unique mechanism as a neurosteroid targeting GABA_A receptors also distinguishes it from monoaminergic drugs.

3. What is the potential market size for zuranolone?
The combined global markets for MDD and PPD are estimated at over $20 billion, with growth driven by increasing awareness, alternative treatments, and expanding indications.

4. What are the primary barriers to zuranolone’s commercial success?
Regulatory approval delays, market competition, high pricing expectations, and payer reimbursement restrictions represent primary challenges.

5. What strategies could enhance zuranolone’s market adoption?
KOL engagement, robust clinical data demonstrating superior efficacy, favorable safety profile, strategic partnerships, and targeted payer negotiations will be essential.

References

[1] Sage Therapeutics. (2022). Zuranolone (SAGE-217): Phase 3 results. Clinical Trial Data.

[2] Grand View Research. (2021). Depression Therapeutics Market Size & Trends.

[3] World Health Organization. (2019). Postpartum depression: Global prevalence and impact.

[4] WHO. (2023). Depression Factsheet.