ASENAPINE - Generic Drug Details

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

Asenapine is the generic ingredient in three branded drugs marketed by Hisamitsu, Alembic, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in five NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Asenapine has thirty-eight patent family members in nine countries.

There are twelve drug master file entries for asenapine. One supplier is listed for this compound.

Summary for ASENAPINE

International Patents:	38
US Patents:	8
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	55
Patent Applications:	5,058
Drug Prices:	Drug price trends for ASENAPINE
What excipients (inactive ingredients) are in ASENAPINE?	ASENAPINE excipients list
DailyMed Link:	ASENAPINE at DailyMed

See drug prices for ASENAPINE

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

Dosage:

SYSTEM;TRANSDERMAL

^*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 ASENAPINE

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

Sponsor	Phase
Lindner Center of HOPE	Phase 2
National Alliance on Mental Illness Montana
CGStat LLC

See all ASENAPINE clinical trials

Pharmacology for ASENAPINE

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ASENAPINE

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for ASENAPINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			Y
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-001	Oct 11, 2019		RX	Yes	Yes			Y
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098-002	Dec 10, 2020	AB	RX	No	No
Hisamitsu	SECUADO	asenapine	SYSTEM;TRANSDERMAL	212268-003	Oct 11, 2019		RX	Yes	No			Y

EU/EMA Drug Approvals for ASENAPINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
N.V. Organon	Sycrest	asenapine	EMEA/H/C/001177 Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults.	Authorised	no	no	no	2010-09-01

International Patents for ASENAPINE

Country	Patent Number	Title	Estimated Expiration
Japan	6005741
European Patent Office	2878300	PATCH
Taiwan	I592170
Japan	WO2014017593	貼付剤及びその製造方法
Spain	2681034

Supplementary Protection Certificates for ASENAPINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0746317	C300461	Netherlands		PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317	SPC/GB10/046	United Kingdom		PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901
0746317	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901

ASENAPINE Market Analysis and Financial Projection Experimental

Asenapine Market Dynamics and Financial Trajectory

Introduction to Asenapine

Asenapine, marketed under the brand name Saphris, is an atypical antipsychotic medication primarily used in the treatment of schizophrenia and bipolar disorder. The drug's unique sublingual administration method and rapid onset of action have made it a valuable therapeutic option in the psychiatric medication landscape.

Market Drivers

Increasing Prevalence of Mental Health Disorders

The rising prevalence of mental health disorders such as schizophrenia and bipolar disorder is a significant driver for the demand for asenapine. As the global population grapples with increasing mental health issues, the need for effective treatments like asenapine has seen a substantial rise[1][2].

Aging Population

An aging population is more susceptible to mental health disorders, which contributes to the increased demand for asenapine. This demographic trend is particularly influential in regions with aging populations, such as North America and Europe[1].

Growing Awareness and Diagnosis

Improved awareness of mental health issues and advancements in diagnostic tools have led to more patients being diagnosed and treated for conditions like schizophrenia and bipolar disorder. This increased diagnosis rate has boosted the demand for asenapine[1][2].

Generic Drug Market Expansion

The expiration of patents for branded drugs has opened up a growing market for generic versions of asenapine. The cost-effectiveness of generic drugs drives the API market, making asenapine more accessible to a broader patient population[1].

Research and Development (R&D) Initiatives

Pharmaceutical companies are investing heavily in R&D to improve the efficacy and safety profile of asenapine. Innovations and new formulations are expected to attract more prescribers, driving market growth[1][2].

Regulatory Approvals and Support

Regulatory approvals for new indications and formulations of asenapine can significantly expand its market. Supportive policies and streamlined approval processes by regulatory bodies also contribute to market growth[1].

Increase in Healthcare Expenditure

Growing healthcare spending, particularly in developing regions, has improved access to mental health treatments. This rise in healthcare infrastructure is a key factor in the growth of the asenapine market[1].

Geographical Market Segments

North America

North America stands out as a leading segment due to its advanced healthcare infrastructure, significant investments in mental health research, and increasing prescriptions for treatments related to schizophrenia and bipolar disorder. The region's stringent regulatory environment and high awareness of mental health issues further drive the demand for asenapine[1].

Europe

Europe follows closely, characterized by its stringent regulatory environment and a growing recognition of the importance of mental health. This has led to a rise in demand for effective antipsychotic medications like asenapine[1].

Asia-Pacific

The Asia-Pacific region is emerging rapidly, driven by increasing awareness of mental health disorders, a burgeoning pharmaceutical industry, and expanding healthcare access. This region presents significant growth opportunities for asenapine API manufacturers[1].

Latin America and Middle East & Africa

Latin America and the Middle East & Africa segments present unique opportunities amid growing healthcare investments. However, these regions face challenges such as economic fluctuations, varying access to medications, and healthcare infrastructure deficits[1].

Financial Trajectory

Market Size and Forecast

The asenapine market is expected to grow at a CAGR of 3 to 5 percent from its estimated valuation by 2031. The market size is categorized based on application (children and adults), product (patch and sublingual tablets), and geographical regions[4][5].

Project Economics

Setting up an asenapine manufacturing plant involves significant capital investments, including costs for land, machinery, raw materials, packaging, transportation, and utilities. The project economics also include operating expenses, income projections, taxation, depreciation, liquidity analysis, and profitability analysis. Key financial metrics such as payback period, net present value (NPV), and internal rate of return (IRR) are crucial for assessing the viability of such projects[2].

Cost and Revenue Analysis

The cost analysis includes detailed insights into feedstock pricing, industry profit margins, and cost variations. The revenue analysis involves income projections, product pricing, and margins. These analyses are essential for understanding the financial health and potential of the asenapine market[2].

Competitive Landscape and Pricing Strategies

The presence of multiple players in the market increases competition, which can drive down prices and increase accessibility. However, it also pushes companies to innovate and improve their product offerings to maintain market share. Pricing strategies are critical in this competitive landscape, as companies need to balance profitability with market demand[1].

Challenges and Opportunities

Supply Chain Disruptions

Global supply chain issues, such as those exacerbated by geopolitical tensions or pandemics, can disrupt the availability of raw materials and increase production costs. This can impact the overall market supply and lead to volatility in pricing[1].

Market Saturation in Developed Regions

In regions like North America and Europe, the market for antipsychotic medications, including those based on asenapine, is approaching saturation. This limits growth opportunities in these regions, compelling companies to explore emerging markets, which come with their own set of challenges such as lower pricing and regulatory hurdles[1].

Technological Advancements in Manufacturing

Technological advancements in manufacturing can improve the efficiency and cost-effectiveness of asenapine production. Innovations in drug delivery methods and formulations can also expand the market by offering better therapeutic options[1].

Regulatory and Compliance Aspects

Regulatory Approvals

Regulatory approvals for new indications and formulations of asenapine are crucial for market expansion. Supportive policies and streamlined approval processes by regulatory bodies can also boost market growth[1].

Certifications and Compliance

Setting up an asenapine manufacturing plant requires compliance with various regulatory certifications. The report provides a comprehensive list of certifications required, along with information related to financial assistance and regulatory procedures[2].

Key Takeaways

• The asenapine market is driven by the increasing prevalence of mental health disorders, an aging population, growing awareness and diagnosis, and the expansion of the generic drug market.
• Geographical segments such as North America, Europe, and the Asia-Pacific region are key markets due to their healthcare infrastructure and regulatory environments.
• The financial trajectory of the asenapine market involves significant capital investments, operating expenses, and income projections, with a CAGR of 3 to 5 percent expected by 2031.
• Challenges include supply chain disruptions, market saturation in developed regions, and the need for compliance with regulatory certifications.

FAQs

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

The primary drivers include the increasing prevalence of mental health disorders, an aging population, growing awareness and diagnosis, and the expansion of the generic drug market[1][2].

Q: Which geographical regions are most significant for the asenapine market?

North America, Europe, and the Asia-Pacific region are the most significant due to their advanced healthcare infrastructure and growing demand for mental health treatments[1].

Q: What are the key financial metrics for assessing the viability of an asenapine manufacturing plant?

Key financial metrics include capital expenditure (CapEx), operating expenditure (OpEx), income projections, payback period, net present value (NPV), and internal rate of return (IRR)[2].

Q: How do supply chain disruptions impact the asenapine market?

Supply chain disruptions can increase production costs and lead to volatility in pricing, impacting the overall market supply and demand for asenapine[1].

Q: What are the regulatory requirements for setting up an asenapine manufacturing plant?

Setting up an asenapine manufacturing plant requires compliance with various regulatory certifications, including detailed regulatory procedures and approvals[2].

Sources

1. Verified Market Research: Asenapine Maleate API Market Size, Share, Trends & Forecast.
2. IMARC Group: Asenapine (Saphris) Manufacturing Plant Project Report 2024.
3. PubMed: Cost-effectiveness of asenapine in the treatment of schizophrenia in ...
4. Market Research Intellect: Global asenapine market size and forecast.
5. Market Research Intellect: Asenapine Market Size And Forecast.