Brexpiprazole - Generic Drug Details

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

Brexpiprazole is the generic ingredient in two branded drugs marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Anda Repository, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Lupin Ltd, Sandoz, Teva Pharms Usa Inc, Zydus Pharms, and Otsuka, and is included in eleven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Brexpiprazole has seventy-four patent family members in thirty-seven countries.

There are eight drug master file entries for brexpiprazole. Four suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for brexpiprazole

International Patents:	74
US Patents:	6
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	80
Clinical Trials:	73
Patent Applications:	647
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for brexpiprazole
What excipients (inactive ingredients) are in brexpiprazole?	brexpiprazole excipients list
DailyMed Link:	brexpiprazole at DailyMed

Recent Clinical Trials for brexpiprazole

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

Sponsor	Phase
H. Lundbeck A/S	Phase 4
Iqvia Pty Ltd	Phase 1
Queen's University	Phase 4

See all brexpiprazole clinical trials

Generic filers with tentative approvals for BREXPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		4MG	TABLET;ORAL
		3MG	TABLET;ORAL
		2MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for brexpiprazole

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for brexpiprazole

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for BREXPIPRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
REXULTI	Tablets	brexpiprazole	0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	205422	18	2019-07-10

US Patents and Regulatory Information for brexpiprazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-005	Jul 10, 2015		RX	Yes	No					Y
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-006	Jul 10, 2015		RX	Yes	No
Anda Repository	BREXPIPRAZOLE	brexpiprazole	TABLET;ORAL	213758-001	Oct 25, 2023		DISCN	No	No
Otsuka	REXULTI	brexpiprazole	TABLET;ORAL	205422-003	Jul 10, 2015		RX	Yes	No					Y

EU/EMA Drug Approvals for brexpiprazole

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Rxulti	brexpiprazole	EMEA/H/C/003841 Treatment of schizophrenia.	Authorised	no	no	no	2018-07-26

International Patents for brexpiprazole

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2402549	ПИПЕРАЗИН-ЗАМЕЩЕННЫЕ БЕНЗОТИОФЕНЫ ДЛЯ ЛЕЧЕНИЯ ПСИХИЧЕСКИХ РАССТРОЙСТВ (PIPERAZINE-SUBSTITUTED BENZOTHIOPHENES FOR TREATING PSYCHIATRIC DISORDERS)
Cyprus	2018028
Japan	WO2013054872
Colombia	6950480

Supplementary Protection Certificates for brexpiprazole

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1869025	C201830050	Spain		PRODUCT NAME: BREXPIPRAZOL O UNA SAL DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726
1869025	303 50013-2018	Slovakia		PRODUCT NAME: BREXPIPRAZOL VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/18/1294 20180730
1869025	300946	Netherlands		PRODUCT NAME: BREXPIPRAZOLE, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/18/1294 20180727
1869025	C 2018 036	Romania		PRODUCT NAME: BREXPIPRAZOL SAU O SARE A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1294; DATE OF NATIONAL AUTHORISATION: 20180726; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1294; DATE OF FIRST AUTHORISATION IN EEA: 20180726

Market Dynamics and Financial Trajectory for Brexpiprazole

Market Overview

Brexpiprazole, a novel atypical antipsychotic medication, has emerged as a promising treatment option for various psychiatric disorders, including schizophrenia, major depressive disorder (MDD), and as an adjunctive therapy for depression. The global brexpiprazole market is poised for significant growth, driven by several key factors.

Market Size and Growth Projections

The brexpiprazole market was valued at approximately USD 1.3 billion in 2023 and is anticipated to reach USD 2.8 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 7.8% during the forecast period from 2024 to 2033[1].

Market Drivers

Increasing Prevalence of Mental Health Disorders

The primary driver for the brexpiprazole market is the increasing prevalence of mental health disorders such as schizophrenia and major depressive disorder. According to the World Health Organization (WHO), mental health disorders affect millions of people worldwide, with depression being a leading cause of disability[1].

Growing Awareness and Demand for Effective Treatments

The growing awareness about mental health and the rising demand for effective and well-tolerated treatments are propelling the adoption of brexpiprazole. This demand is further fueled by the expanding indications for brexpiprazole, such as its potential use in treating agitation associated with Alzheimer's disease[1].

Focus on Personalized Medicine

The increasing focus on personalized medicine and the development of targeted therapies are also contributing to the market's expansion. This shift towards personalized medicine is expected to drive the development of novel formulations and combination therapies[1].

Market Opportunities

Emerging Markets

The increasing focus on mental health in emerging markets such as Asia-Pacific and Latin America offers untapped potential for market players. Countries like China, India, and Japan are expected to contribute significantly to the market's growth due to their large patient populations and improving healthcare infrastructure[1].

Long-Acting Injectable Formulations

The development of long-acting injectable formulations of brexpiprazole could improve patient compliance and convenience, thereby driving adoption. This format is particularly beneficial in hospital settings where patient adherence is a significant concern[1].

New Indications

The exploration of new indications, such as the treatment of post-traumatic stress disorder (PTSD) and bipolar disorder, could further expand the market's scope. For instance, if approved, brexpiprazole in combination with sertraline could represent an important advancement over the current standard of care for PTSD[3].

Collaborations and Partnerships

Collaborations and partnerships between pharmaceutical companies and research institutions could accelerate the development of novel formulations and combination therapies, enhancing the market's growth prospects[1].

Regional Analysis

North America

North America dominates the global brexpiprazole market, primarily due to the high prevalence of mental health disorders, the well-established healthcare infrastructure, and the presence of key market players in the region. The United States is the largest contributor to the North American market, driven by increasing awareness about mental health and favorable reimbursement scenarios[1].

Europe

Europe holds the second-largest share of the global market, supported by the growing prevalence of psychiatric disorders and well-developed healthcare systems. Countries such as Spain, Italy, and France are contributing significantly to the market growth in this region[1].

Asia-Pacific

The Asia-Pacific market is expected to witness the highest growth rate during the forecast period, fueled by the large patient population, improving healthcare infrastructure, and increasing awareness about mental health disorders in countries such as China, India, and Japan[1].

Financial Performance and Trajectory

Revenue Growth

Lundbeck, a key player in the brexpiprazole market, has reported strong revenue growth for its strategic brands, including brexpiprazole. The company's revenue from brexpiprazole, marketed under the brand name Rexulti, has shown significant growth, contributing to the overall financial performance of the company[2][3].

Segment Performance

The hospital pharmacies segment accounts for a substantial portion of the brexpiprazole market, attributed to the high volume of prescriptions generated in hospital settings. However, the retail pharmacies segment is expected to witness significant growth due to the increasing number of retail pharmacy chains and the growing trend of home healthcare[1].

Geographic Revenue Distribution

The revenue distribution by region for Lundbeck's strategic brands, including brexpiprazole, shows a strong presence in the U.S., Europe, and International Markets. The U.S. accounts for the largest share, followed by Europe and then International Markets such as Canada, Brazil, Australia, and Mexico[3].

Future Outlook

Shift Towards Personalized Medicine

The market is expected to witness a shift towards personalized medicine, with the development of targeted therapies and the increasing adoption of pharmacogenomic testing. This trend is likely to drive the growth of brexpiprazole as it aligns with the need for more tailored treatment options[1].

Generic Competitors and Long-Acting Formulations

The entry of generic competitors and the development of long-acting injectable formulations are likely to shape the market landscape. While generic competitors may pose a challenge, the convenience and compliance benefits of long-acting formulations are expected to maintain market demand[1].

Challenges

Despite the positive outlook, challenges such as patent expiration, high drug costs, and potential side effects of brexpiprazole may hinder market growth to some extent. However, these challenges are expected to be mitigated by the ongoing development of new formulations and the expanding indications for brexpiprazole[1].

Key Takeaways

• The global brexpiprazole market is projected to grow significantly, reaching USD 2.8 billion by 2033.
• The market is driven by the increasing prevalence of mental health disorders and the growing demand for effective treatments.
• Emerging markets and the development of long-acting injectable formulations offer significant growth opportunities.
• North America and Europe are the dominant regions, with Asia-Pacific expected to show the highest growth rate.
• The market is shifting towards personalized medicine, which will drive the development of targeted therapies.

FAQs

Q: What is the current market size of brexpiprazole and its projected growth?

The brexpiprazole market was valued at approximately USD 1.3 billion in 2023 and is anticipated to reach USD 2.8 billion by 2033, growing at a CAGR of 7.8% during the forecast period[1].

Q: What are the primary drivers of the brexpiprazole market?

The primary drivers include the increasing prevalence of mental health disorders, growing awareness and demand for effective treatments, and the expanding indications for brexpiprazole[1].

Q: Which regions are expected to contribute significantly to the growth of the brexpiprazole market?

North America, Europe, and the Asia-Pacific region are expected to contribute significantly, with the Asia-Pacific region showing the highest growth rate[1].

Q: What are the potential challenges facing the brexpiprazole market?

Challenges include patent expiration, high drug costs, and potential side effects of brexpiprazole. However, these are expected to be mitigated by new formulations and expanding indications[1].

Q: How is the shift towards personalized medicine expected to impact the brexpiprazole market?

The shift towards personalized medicine is expected to drive the development of targeted therapies and increase the adoption of pharmacogenomic testing, aligning with the need for more tailored treatment options[1].

Sources

1. DataHorizon Research: Brexpiprazole Market Size, Share, Growth, Statistics Report 2033.
2. Lundbeck: 9M 2023 Investor Presentation.
3. Lundbeck: Q2 2024 Final Report.
4. Market Research Intellect: Global Brexpiprazole Market Size, Trends and Projections.