ZURANOLONE - Generic Drug Details

What are the generic drug sources for zuranolone and what is the scope of patent protection?

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 six patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for ZURANOLONE

International Patents:	106
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	1
Patent Applications:	79
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
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

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	217369-002	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	10,342,810
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-001	Oct 31, 2023		RX	Yes	No	10,172,871
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	10,342,810
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-002	Oct 31, 2023		RX	Yes	No	11,884,696
Biogen Inc	ZURZUVAE	zuranolone	CAPSULE;ORAL	217369-003	Oct 31, 2023		RX	Yes	Yes	10,172,871

International Patents for ZURANOLONE

Country	Patent Number	Title	Estimated Expiration
Australia	2020256400	19-Nor C3,3-Disubstituted C21-N-Pyrazolyl Steroids And Methods Of Use Thereof
South Korea	20230172622	19-노르 C3,3-이치환된 C21-N-피라졸릴 스테로이드 및 그의 사용 방법 (19- C33- C21-N- 19-NOR C33-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF)
Croatia	P20211314
Singapore	10201802389S	19-NOR C3,3-DISUBSTITUTED C21-N-PYRAZOLYL STEROIDS AND METHODS OF USE THEREOF
Argentina	125320	COMPUESTO CRISTALINO, MÉTODO DE PREPARACIÓN Y COMPOSICIÓN QUE LO COMPRENDE
Japan	6470258
South Africa	201901051	A CRYSTALLINE 19-NOR C3, 3-DISUBSTITUTED C21-N-PYRAZOLYL STEROID

Market Dynamics and Financial Trajectory for Zuranolone

Introduction

Zuranolone, marketed as ZURZUVAE, is a significant development in the treatment of postpartum depression (PPD) and has been at the forefront of recent pharmaceutical news. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, challenges, and future prospects.

FDA Approval and Market Impact

In August 2023, the FDA approved ZURZUVAE as the first oral therapy for postpartum depression, marking a crucial milestone for Sage Therapeutics and its partner Biogen. However, the FDA's decision to reject the approval for major depressive disorder (MDD) significantly impacted the drug's potential market size. This limited approval led to a sharp decline in Sage Therapeutics' stock value, highlighting the market's reliance on broader therapeutic applications[3].

Revenue and Collaboration

The third quarter of 2024 saw Sage Therapeutics achieve $11 million in collaboration revenue from ZURZUVAE, representing a 49% growth from the second quarter. This revenue is 50% of the net revenue recorded by Biogen for ZURZUVAE in the U.S.[1].

Financial Performance

• Revenue Growth: The collaboration revenue from ZURZUVAE has shown significant growth, with $11 million in the third quarter of 2024, up from $2.5 million in the second quarter of 2023 for ZULRESSO, another product from Sage[1][2].
• Cash Position: As of September 30, 2024, Sage Therapeutics had $569 million in cash, cash equivalents, and marketable securities, down from $647 million at June 30, 2024. This decrease is part of the company's strategic reorganization to extend its cash runway and focus on long-term growth[1].
• Operating Costs: The company has incurred significant research and development (R&D) and selling, general, and administrative (SG&A) expenses. In the second quarter of 2023, R&D expenses were $97.2 million, and SG&A expenses were $75.6 million. These costs are expected to be managed through the ongoing reorganization[2].

Market Size and Growth

The global postpartum depression treatment market is projected to grow significantly, from $79.9 million in 2024 to $973.0 million by 2032, at a CAGR of 36.7%. ZURZUVAE is expected to be a key driver in this growth, particularly due to its advantages such as lower cost and ease of administration compared to brexanolone, the first FDA-approved drug for PPD[4].

Distribution and Accessibility

Sage Therapeutics and Biogen have partnered with national specialty pharmacies to distribute ZURZUVAE directly to patients. This strategy enhances accessibility and convenience for women with PPD, contributing to the drug's market growth[4].

Competitive Landscape

The postpartum depression treatment market is currently dominated by brexanolone, but ZURZUVAE is poised to be the fastest-growing segment. The market is driven by the rising prevalence of PPD and increasing awareness about the disease. Sage Therapeutics and Biogen are major players in this market, with ZURZUVAE expected to capture a significant share due to its oral administration and lower cost[4].

Challenges and Strategic Adjustments

• FDA Decision: The FDA's decision not to approve ZURZUVAE for MDD has forced Sage Therapeutics to reevaluate its pipeline and focus more on PPD. This shift has led to a strategic reorganization aimed at reducing operating expenses and extending the company's cash runway[1][3].
• Cost Management: The company is implementing cost-cutting measures, including workforce reorganization, to ensure long-term sustainability. This includes discontinuing the commercial availability of ZULRESSO by December 31, 2024[1].

Future Prospects

• Clinical Trials: Topline data from the DIMENSION Study in Huntington’s Disease (HD) is expected late in 2024, which could open up additional therapeutic avenues for ZURZUVAE[1].
• Market Estimates: Despite the challenges, analysts predict that ZURZUVAE could generate significant revenue, with estimates ranging from $250 million to $1 billion in annual sales at its peak[3].

Expert Insights

"Despite the structural differences, zuranolone's clinical effect looks like that of a benzodiazepine and that profile is unlikely to secure a large market opportunity as a result," noted analyst Geoffrey Skorney. However, the drug's potential in PPD remains strong, with Paul Matteis of Stifel predicting it could still generate substantial revenue at a high premium price[3].

Key Takeaways

• ZURZUVAE has been approved as the first oral therapy for postpartum depression.
• The drug has shown significant revenue growth but faces challenges due to limited FDA approval.
• Sage Therapeutics is undergoing a strategic reorganization to manage costs and focus on long-term growth.
• The global postpartum depression treatment market is expected to grow substantially, with ZURZUVAE playing a crucial role.
• Distribution partnerships with specialty pharmacies enhance the drug's accessibility.

FAQs

Q: What is ZURZUVAE, and what is it used for? A: ZURZUVAE (zuranolone) is an oral therapy approved by the FDA for the treatment of postpartum depression (PPD).

Q: Why did Sage Therapeutics' stock value decline after the FDA approval? A: The decline was due to the FDA's decision not to approve ZURZUVAE for major depressive disorder (MDD), which limited the drug's potential market size.

Q: How is ZURZUVAE distributed to patients? A: Sage Therapeutics and Biogen have partnered with national specialty pharmacies to distribute ZURZUVAE directly to patients.

Q: What are the future prospects for ZURZUVAE in terms of revenue? A: Analysts predict that ZURZUVAE could generate significant revenue, ranging from $250 million to $1 billion in annual sales at its peak.

Q: What other therapeutic areas is ZURZUVAE being evaluated for? A: Besides PPD, ZURZUVAE is being evaluated for Huntington’s Disease (HD), with topline data from the DIMENSION Study expected late in 2024.

Cited Sources

1. Sage Therapeutics Announces Third Quarter 2024 Financial Results and Highlights Pipeline and Business Updates - Investor.sagerx.com
2. Sage Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Pipeline and Business Progress - Biospace.com
3. Sage considers cuts after FDA's split decision on depression drug - Biopharmadive.com
4. Postpartum Depression Treatment Market Size, Forecast [2032] - Fortunebusinessinsights.com
5. Fourth Quarter and Full Year 2023 Financial Results - Investor.sagerx.com