ASENDIN Drug Patent Profile

When do Asendin patents expire, and what generic alternatives are available?

Asendin is a drug marketed by Lederle and is included in one NDA.

The generic ingredient in ASENDIN is amoxapine. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the amoxapine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Asendin

A generic version of ASENDIN was approved as amoxapine by CHARTWELL RX on June 28^th, 1991.

Summary for ASENDIN

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	117
Patent Applications:	6,050
DailyMed Link:	ASENDIN at DailyMed

US Patents and Regulatory Information for ASENDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ASENDIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-002	Approved Prior to Jan 1, 1982	3,681,357
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-001	Approved Prior to Jan 1, 1982	3,546,226
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	3,681,357
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	3,546,226
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-003	Approved Prior to Jan 1, 1982	3,663,696
Lederle	ASENDIN	amoxapine	TABLET;ORAL	018021-004	Approved Prior to Jan 1, 1982	3,681,357

International Patents for ASENDIN

See the table below for patents covering ASENDIN around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	252925
Israel	27860	THERAPEUTIC COMPOSITION CONTAINING 2-CHLORO-11-(1-PIPERAZINYL)-DIBENZ (B,F) (1,4) OXAZEPINE FOR THE TREATMENT OF DEPRESSION
Israel	29571	11-SUBSTITUTED DIBENZO(B,F)-1,4-OXAZEPINES,DIBENZO(B,F)-1,4-THIAZEPINES AND DIBENZO(B,E)-1,4-DIAZEPINES AND THEIR PREPARATION
Switzerland	485750	Verfahren zur Herstellung basisch substituierter Heterocyclen
Switzerland	450424	Verfahren zur Herstellung 11-basisch substituierter Dibenz(b,f)(1,4)oxazepine
Brazil	6457122

Market Dynamics and Financial Trajectory for Asenapine (Asendin)

Last updated: December 17, 2024

Introduction

Asenapine, marketed under the brand name Asendin among others, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and bipolar disorder. Understanding the market dynamics and financial trajectory of asenapine is crucial for pharmaceutical companies, investors, and healthcare providers.

Market Size and Forecast

The asenapine market is expected to exhibit significant growth over the forecast period. Here are some key points:

• Market Size: The asenapine market is projected to expand substantially from 2021 to 2031. The market size is measured in USD million and is segmented by application, product, and geographical regions[3].
• Growth Trajectory: Projections indicate an upward trend in market dynamics, suggesting a steady increase in demand and revenue over the next decade[3].

Segmentation

The asenapine market is segmented into several key categories:

By Application

• Children: Asenapine is used in pediatric populations for certain psychiatric conditions, although its use in this age group is less common compared to adults.
• Adults: The primary market for asenapine, where it is used to treat schizophrenia and bipolar disorder[3].

By Product

• Patch: Transdermal patches are one form of asenapine administration, offering a convenient and steady release of the medication.
• Sublingual Tablets: The most common form of asenapine, these tablets are placed under the tongue and dissolve quickly, providing rapid absorption[3].

By Geography

• North America: A significant market for asenapine due to high prevalence rates of psychiatric disorders and advanced healthcare infrastructure.
• Europe: Another major market, driven by similar factors as North America.
• Asia-Pacific: Expected to grow rapidly due to increasing awareness and improving healthcare systems.
• South America and Middle-East & Africa: These regions also contribute to the market, though to a lesser extent[3].

Key Market Players

Several pharmaceutical companies play a crucial role in the asenapine market:

• Merck: Known for its extensive portfolio of pharmaceutical products, including asenapine.
• Targetmol: A company focused on providing high-quality pharmaceuticals and research chemicals.
• Actavis: Now part of Teva Pharmaceutical Industries, Actavis has a significant presence in the generic and branded pharmaceutical market.
• Noven Pharmaceuticals: Specializes in transdermal patches, including those for asenapine.
• Lundbeck A/S: A global pharmaceutical company with a strong focus on psychiatric and neurological disorders[3].

Market Drivers

Several factors drive the growth of the asenapine market:

Increasing Prevalence of Psychiatric Disorders

• The rising incidence of schizophrenia and bipolar disorder globally contributes significantly to the demand for asenapine. According to the World Health Organization, mental health conditions are a major cause of disability worldwide[1].

Advancements in Treatment Options

• The development of new formulations, such as transdermal patches, enhances patient compliance and convenience, driving market growth[3].

Public Awareness and Healthcare Infrastructure

• Increasing public awareness of mental health issues and improvements in healthcare infrastructure, particularly in developing regions, are key drivers of the market[1].

Financial Trajectory

The financial trajectory of the asenapine market is promising:

• Revenue Growth: The market is expected to generate significant revenue over the forecast period, driven by the increasing demand for effective treatments for psychiatric disorders[3].
• CAGR: While specific CAGR figures for asenapine are not provided, the overall antipsychotic drugs market, which includes asenapine, is expected to grow at a CAGR of around 2.5% over similar periods[4].

Challenges and Opportunities

Despite the positive outlook, there are challenges and opportunities to consider:

Challenges

• Generic Competition: The availability of generic versions of asenapine can impact the market share of branded products.
• Regulatory Environment: Strict regulatory requirements and the need for continuous clinical trials can pose challenges for market growth[3].

Opportunities

• Emerging Markets: Growing awareness and improving healthcare systems in emerging markets present significant opportunities for expansion.
• Research and Development: Continuous R&D efforts to improve existing formulations and develop new ones can drive innovation and growth[3].

Economic Impact

The economic impact of asenapine and other antipsychotic medications is substantial:

• Direct and Indirect Costs: The treatment of psychiatric disorders involves significant direct costs (medications, healthcare services) and indirect costs (lost productivity, workplace costs). For example, the economic burden of major depressive disorder (MDD) in the U.S. was estimated at $236 billion in 2018, with a significant portion attributed to indirect costs[5].

Key Takeaways

• The asenapine market is expected to grow significantly over the next decade.
• Segmentation by application, product, and geography highlights key areas of focus.
• Increasing prevalence of psychiatric disorders and advancements in treatment options drive market growth.
• The financial trajectory is positive, with revenue growth driven by increasing demand.
• Challenges include generic competition and regulatory hurdles, while opportunities lie in emerging markets and R&D.

Frequently Asked Questions

Q: What are the primary applications of asenapine? A: Asenapine is primarily used to treat schizophrenia and bipolar disorder in both children and adults, though its use is more common in adults[3].

Q: What forms of asenapine are available? A: Asenapine is available in sublingual tablets and transdermal patches[3].

Q: Who are the key players in the asenapine market? A: Key players include Merck, Targetmol, Actavis, Noven Pharmaceuticals, and Lundbeck A/S[3].

Q: What drives the growth of the asenapine market? A: The growth is driven by the increasing prevalence of psychiatric disorders, advancements in treatment options, and improving healthcare infrastructure[1][3].

Q: What are the challenges facing the asenapine market? A: Challenges include generic competition, regulatory hurdles, and the need for continuous clinical trials[3].

Cited Sources

1. US Anti-Depressants Drugs Market Report 2022 to 2030 - Insights10
2. FINAL REPORT Evaluation of Healthcare Costs and Utilization - Interact for Health
3. Asenapine Market Size And Forecast - Market Research Intellect
4. Global Antipsychotic Drugs Market Analysis & Trends 2014-2016 - Business Wire
5. Depression and Suicide - NetCE