BREXANOLONE - Generic Drug Details

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

Brexanolone is the generic ingredient in one branded drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for BREXANOLONE

International Patents:	123
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	11
Patent Applications:	1,004
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BREXANOLONE
What excipients (inactive ingredients) are in BREXANOLONE?	BREXANOLONE excipients list
DailyMed Link:	BREXANOLONE at DailyMed

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

Constraining patent/regulatory exclusivity:

7,635,773

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 BREXANOLONE

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

Sponsor	Phase
Brii Biosciences Limited	Phase 1
Sage Therapeutics	Phase 2
Brigham and Women's Hospital	Phase 4

See all BREXANOLONE clinical trials

Pharmacology for BREXANOLONE

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 BREXANOLONE

N06AX	Other antidepressants
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for BREXANOLONE

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	9,200,088		Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	9,750,822		Y
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
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	8,410,077		Y
Sage Therap	ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371-001	Jun 17, 2019		RX	Yes	Yes	7,635,773		Y

International Patents for BREXANOLONE

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
Russian Federation	2681835	ЛЕКАРСТВЕННЫЕ ФОРМЫ НЕЙРОАКТИВНЫХ СТЕРОИДОВ И СПОСОБЫ ЛЕЧЕНИЯ НАРУШЕНИЙ ЦНС (NEUROACTIVE STEROID FORMULATIONS AND METHODS OF TREATING CNS DISORDERS)

BREXANOLONE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Brexanolone

Introduction to Brexanolone

Brexanolone, marketed as ZULRESSO, is a groundbreaking drug specifically approved by the FDA for the treatment of postpartum depression (PPD). It is the first FDA-approved medication for this condition and has significantly impacted the PPD treatment landscape.

Market Dominance and Growth

In 2023, brexanolone dominated the postpartum depression drug market, marking a substantial shift in how PPD is managed. This dominance is attributed to its rapid onset of action and effectiveness in alleviating severe symptoms of PPD through intravenous infusion[1].

Drug Characteristics and Benefits

Brexanolone is a neuroactive steroid that targets the neurochemical imbalances associated with postpartum depression. Its rapid onset of action makes it particularly beneficial for patients in need of immediate relief from severe symptoms. This characteristic has driven market growth and expanded the therapeutic options available for PPD[1].

Regional Insights

North America, particularly the United States, has been a key driver in the global PPD drugs market, including brexanolone. The region's strong healthcare infrastructure, high awareness of PPD, and significant investment in research and development have contributed to its market leadership. The presence of key pharmaceutical companies and favorable reimbursement policies further support market growth in this region[1].

Financial Performance

Revenue and Sales

As of the second quarter of 2023, the net revenue from sales of ZULRESSO (brexanolone) was $2.5 million, up from $1.5 million in the same period of 2022. This increase indicates growing adoption and acceptance of the drug in the market[2].

Research and Development Expenses

Sage Therapeutics, the company behind brexanolone, has seen an increase in research and development expenses. In the second quarter of 2023, R&D expenses were $97.2 million, reflecting the company's commitment to further developing and improving treatments for PPD. This includes costs associated with hiring employees and enhancing corporate infrastructure to support growth in R&D operations[2].

Selling, General, and Administrative Expenses

Selling, general, and administrative (SG&A) expenses also saw an increase, primarily due to hiring employees to support ongoing activities and the potential launch of other drugs like zuranolone. In the second quarter of 2023, SG&A expenses were $75.6 million, up from $52.4 million in the same period of 2022[2].

Net Loss

Despite the revenue growth, Sage Therapeutics reported a net loss of $160.3 million in the second quarter of 2023, compared to $126.3 million in the same period of 2022. This net loss is largely due to the increased operating costs and expenses associated with R&D and SG&A activities[2].

Market Drivers and Opportunities

Innovative Therapies

The approval of brexanolone and other novel drugs like zuranolone has significantly driven the market by introducing innovative therapies that enhance treatment options for PPD. These drugs address the urgent need for effective treatments and cater to varying patient preferences and conditions[1].

Regulatory Support

Regulatory agencies, such as the FDA, have created accelerated approval pathways for breakthrough therapies, which has been critical for PPD drugs. This support encourages pharmaceutical companies to invest in developing innovative treatments by reducing the time and cost associated with bringing new drugs to market[4].

Growing Awareness and Diagnosis

The growing awareness and diagnosis of PPD, coupled with the increasing emphasis on mental health, are expected to propel growth in the pharmacotherapy segment of the PPD drug market. This includes the development of faster-acting and more effective drugs, further expanding therapeutic options[1].

Challenges and Restraints

Market Competition and Substitutes

The PPD drug market faces competition from various substitutes, including psychotherapy, lifestyle interventions, and other alternative treatments. These alternatives can impact the adoption rate of pharmacological treatments like brexanolone[4].

Regulatory and Commercial Challenges

Sage Therapeutics may encounter issues related to market acceptance, reimbursement, and commercialization of brexanolone. These challenges can affect the drug's revenue expectations and overall market performance[3].

Future Outlook

Revenue Growth

Despite current challenges, the revenue from brexanolone is expected to grow modestly over the next couple of quarters. Sage Therapeutics anticipates an increase in the rate of growth of ZULRESSO revenue in the future, driven by an increase in the number of treatment-ready sites and the volume of patients treated at existing sites[3].

Expanding Therapeutic Landscape

The continuous evolution of drug formulations and delivery methods, such as the development of oral neuroactive steroids like zuranolone, will further expand the therapeutic landscape for PPD. This innovation is expected to drive market growth and improve patient outcomes[1].

Key Takeaways

• Brexanolone (ZULRESSO) is the first FDA-approved drug specifically for postpartum depression, offering rapid relief through intravenous infusion.
• The drug has dominated the PPD market in 2023, driven by its effectiveness and the strong healthcare infrastructure in North America.
• Financial performance shows increasing revenue but also significant R&D and SG&A expenses.
• Market growth is driven by innovative therapies, regulatory support, and growing awareness of PPD.
• Challenges include market competition, regulatory hurdles, and commercialization issues.

FAQs

What is brexanolone, and how does it work?

Brexanolone, marketed as ZULRESSO, is a neuroactive steroid that targets the neurochemical imbalances associated with postpartum depression. It is administered intravenously and offers rapid relief from severe symptoms of PPD.

What are the key benefits of brexanolone?

The key benefits include its rapid onset of action, effectiveness in alleviating severe symptoms of PPD, and the expansion of therapeutic options for patients.

Which region dominates the market for brexanolone?

North America, particularly the United States, dominates the market for brexanolone due to its strong healthcare infrastructure, high awareness of PPD, and significant investment in research and development.

What are the financial challenges faced by Sage Therapeutics in commercializing brexanolone?

Sage Therapeutics faces challenges related to market acceptance, reimbursement, and commercialization, which can affect revenue expectations. Additionally, the company incurs significant R&D and SG&A expenses.

What is the future outlook for brexanolone revenue?

The revenue from brexanolone is expected to grow modestly over the next couple of quarters, driven by an increase in the number of treatment-ready sites and the volume of patients treated at existing sites.

Cited Sources:

1. Stellarmr.com: Postpartum Depression drug market - Industry Analysis and Forecast.
2. Biospace.com: Sage Therapeutics Announces Second Quarter 2023 Financial Results and Highlights Pipeline and Business Progress.
3. Investor.sagerx.com: Investor Presentation - Sage Therapeutics, Inc.
4. Grandviewresearch.com: Postpartum Depression Drugs Market Size Report, 2030.
5. Investor.sagerx.com: Sage Therapeutics Announces Third Quarter 2024 Financial Results.