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ZULRESSO Drug Patent Profile

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

Zulresso is a drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this drug.

This drug has one hundred and twenty-three patent family members in thirty-one countries.

The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. Additional details are available on the brexanolone profile page.

DrugPatentWatch^® Generic Entry Outlook for Zulresso

Zulresso was eligible for patent challenges on June 17, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 13, 2029. This may change due to patent challenges or generic licensing.

There have been six 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 ZULRESSO

International Patents:	123
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	7
Patent Applications:	524
Drug Prices:	Drug price information for ZULRESSO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZULRESSO
What excipients (inactive ingredients) are in ZULRESSO?	ZULRESSO excipients list
DailyMed Link:	ZULRESSO at DailyMed

See drug prices for ZULRESSO

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

Constraining patent/regulatory exclusivity:

7,635,773

NDA:

211371

Dosage:

SOLUTION;INTRAVENOUS

^*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 ZULRESSO

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

Sponsor	Phase
Brigham and Women's Hospital	Phase 4
Donald Jeffrey Newport	Phase 4
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 1

See all ZULRESSO clinical trials

Pharmacology for ZULRESSO

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 ZULRESSO

ZULRESSO is protected by eight US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 7,635,773.

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
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	10,940,156
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	10,322,139		Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	9,200,088		Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	10,117,951		Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	10,251,894
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	8,410,077		Y

International Patents for ZULRESSO

When does loss-of-exclusivity occur for ZULRESSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Mexico

New Zealand

South Korea

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 ZULRESSO around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2023093723	神経刺激性ステロイド、組成物、およびその使用 (NEUROACTIVE STEROIDS, COMPOSITIONS, AND USES THEREOF)
New Zealand	627781	Neuroactive steroid formulations and methods of treating cns disorders
Cyprus	1122527
Morocco	43815	STÉROÏDES NEUROACTIFS, COMPOSITIONS, ET LEURS UTILISATIONS
Mexico	2019009739	FORMULACIONES DE ESTEROIDES NEUROACTIVOS Y METODOS PARA TRATAR TRASTORNOS DEL CNS. (NEUROACTIVE STEROID FORMULATIONS AND METHODS OF TREATING CNS DISORDERS.)
China	104736158	Neuroactive steroid formulations and methods of treating CNS disorders

ZULRESSO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ZULRESSO

Introduction

ZULRESSO (brexanolone) is a drug developed by Sage Therapeutics for the treatment of postpartum depression (PPD) in adult women. Here, we will delve into the market dynamics and financial trajectory of ZULRESSO, highlighting key aspects such as revenue trends, market projections, and the strategic decisions impacting its commercial availability.

Market Indications and Usage

ZULRESSO is specifically indicated for the treatment of postpartum depression in adult women. It is administered as an intravenous infusion under medical supervision, addressing a critical need in the management of PPD[4].

Revenue Trends

Historical Revenue

In the second quarter of 2023, net revenue from sales of ZULRESSO was $2.5 million, up from $1.5 million in the same period of 2022. However, this growth was not sustained, as by the third quarter of 2024, the net revenue from ZULRESSO had dropped to $0.8 million, compared to $2.7 million in the same period of 2023[1][2].

Decline in Revenue

The decline in revenue can be attributed to several factors, including the increasing competition from other treatments and the strategic shift by Sage Therapeutics to focus more on ZURZUVAE (zuranolone), another drug for PPD. The uptake of ZURZUVAE has led to a decrease in the use of ZULRESSO, prompting Sage to decide against further commercialization of ZULRESSO beyond December 31, 2024[1].

Market Projections

Despite the current decline, market reports had initially projected significant growth for ZULRESSO. For instance, a report by DelveInsight anticipated that the ZULRESSO market size would increase substantially by 2032, covering major markets including the United States, EU4, the United Kingdom, and Japan. However, these projections seem less likely given the current market dynamics and Sage's decision to discontinue ZULRESSO's commercial availability[4].

Cost of Revenues and Expenses

The financial performance of ZULRESSO has been impacted by various costs. In the third quarter of 2024, the cost of revenues for ZULRESSO included $3.6 million in one-time excess inventory write-offs and intangible asset impairment costs related to its planned discontinuation. This has significantly affected the overall financial health of the product[1].

Strategic Decisions and Impact

Shift to ZURZUVAE

Sage Therapeutics has made a strategic decision to focus on the commercialization of ZURZUVAE, which has shown promising results and growth. In the third quarter of 2024, collaboration revenue from ZURZUVAE was $11 million, representing a 49% increase from the second quarter of 2024. This shift indicates a prioritization of resources towards ZURZUVAE, further diminishing the commercial viability of ZULRESSO[1].

Discontinuation of Commercial Availability

As of December 31, 2024, Sage Therapeutics will no longer make ZULRESSO commercially available. This decision aligns with the company's strategy to concentrate on more promising products and reduce operating expenses. The discontinuation reflects the declining market performance and the need to allocate resources more efficiently[1].

Financial Guidance and Cash Runway

Sage Therapeutics anticipates that its existing cash, cash equivalents, and marketable securities, along with anticipated funding from ongoing collaborations and estimated revenues, will support its operations into 2026. However, this guidance does not include any potential savings from the October 2024 reorganization. The company expects operating expenses to decrease in 2025 relative to 2024, partly due to the discontinuation of ZULRESSO and the focus on more cost-effective strategies[1].

Competitive Landscape

The competitive landscape for PPD treatments is evolving, with ZURZUVAE emerging as a strong contender. The decision to discontinue ZULRESSO highlights the competitive pressures and the need for pharmaceutical companies to continuously evaluate and adjust their product portfolios to remain viable. Other treatments and emerging therapies in the PPD market will continue to influence the dynamics, making it crucial for companies to innovate and adapt[4].

Key Takeaways

• Declining Revenue: ZULRESSO's revenue has been declining, with a significant drop in the third quarter of 2024.
• Strategic Shift: Sage Therapeutics is focusing on ZURZUVAE, leading to the discontinuation of ZULRESSO's commercial availability.
• Market Projections: Initial market projections for ZULRESSO's growth are unlikely to materialize due to current market dynamics.
• Cost Implications: The discontinuation includes significant one-time costs related to inventory write-offs and asset impairment.
• Financial Guidance: Sage's financial guidance indicates support for operations into 2026, with expected decreases in operating expenses.

FAQs

What is ZULRESSO used for?

ZULRESSO is used for the treatment of postpartum depression (PPD) in adult women, administered as an intravenous infusion under medical supervision[4].

Why is Sage Therapeutics discontinuing ZULRESSO?

Sage Therapeutics is discontinuing ZULRESSO due to its strategic shift to focus on the commercialization of ZURZUVAE, which has shown more promising results and growth[1].

What are the financial implications of discontinuing ZULRESSO?

The discontinuation includes one-time costs such as excess inventory write-offs and intangible asset impairment costs. It also aligns with the company's strategy to reduce operating expenses and extend its cash runway[1].

How does ZURZUVAE compare to ZULRESSO in terms of revenue?

In the third quarter of 2024, collaboration revenue from ZURZUVAE was $11 million, a 49% increase from the second quarter, while ZULRESSO's revenue was $0.8 million, a significant decline from previous periods[1].

What is the expected market size of ZULRESSO by 2032?

Initial projections suggested a significant increase in the market size of ZULRESSO by 2032, but these are unlikely to materialize given the current market dynamics and the discontinuation of ZULRESSO[4].

Sources

1. Sage Therapeutics Announces Third Quarter 2024 Financial Results and Highlights Pipeline and Business Updates. Sage Therapeutics.
2. Sage Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Pipeline and Business Progress. BioSpace.
3. Sage braces for make-or-break depression data. BioPharma Dive.
4. ZULRESSO Market Size expected to increase many folds by 2032. OpenPR.
5. Investor Presentation - Sage Therapeutics, Inc.. Sage Therapeutics.