ASENAPINE MALEATE - Generic Drug Details

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

Asenapine maleate is the generic ingredient in two branded drugs marketed by Alembic, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for asenapine maleate. Seven suppliers are listed for this compound.

Summary for ASENAPINE MALEATE

US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	2
Patent Applications:	163
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ASENAPINE MALEATE
What excipients (inactive ingredients) are in ASENAPINE MALEATE?	ASENAPINE MALEATE excipients list
DailyMed Link:	ASENAPINE MALEATE at DailyMed

Recent Clinical Trials for ASENAPINE MALEATE

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

Sponsor	Phase
Accutest Research Laboratories (I) Pvt. Ltd.	Phase 2/Phase 3
Amneal Pharmaceuticals, LLC	Phase 2/Phase 3
Sun Pharmaceutical Industries Limited	Phase 1

See all ASENAPINE MALEATE clinical trials

Pharmacology for ASENAPINE MALEATE

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ASENAPINE MALEATE

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

Paragraph IV (Patent) Challenges for ASENAPINE MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAPHRIS	Sublingual Tablets	asenapine maleate	2.5 mg	022117	1	2017-07-27
SAPHRIS	Sublingual Tablets	asenapine maleate	5 mg and 10 mg	022117	4	2013-08-13

US Patents and Regulatory Information for ASENAPINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	AB	RX	Yes	Yes	8,022,228*PED				Y
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-001	Dec 10, 2020	AB	RX	No	No
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	AB	RX	Yes	Yes	7,741,358*PED				Y
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-003	Mar 8, 2021	AB	RX	No	No
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098-003	Jul 19, 2021	AB	RX	No	No

Expired US Patents for ASENAPINE MALEATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	5,763,476*PED
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	5,763,476*PED
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	5,763,476*PED

ASENAPINE MALEATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Asenapine Maleate

Introduction

Asenapine maleate, an antipsychotic medication, is primarily used in the treatment of schizophrenia and bipolar disorder. The market for this drug is influenced by several key factors, including increasing prevalence of mental health disorders, demographic trends, and advancements in pharmaceutical technology.

Market Size and Forecast

The Asenapine Maleate API market is expected to grow significantly over the forecast period from 2024 to 2030. This growth is driven by a moderate pace of expansion in recent years, with the market estimated to increase at a CAGR of 3 to 5 percent[3].

Drivers of Market Growth

Increasing Prevalence of Mental Health Disorders

The rising prevalence of schizophrenia and bipolar disorder worldwide is a significant driver for the demand for Asenapine Maleate. As mental health awareness and diagnostic capabilities improve, more patients are being diagnosed and treated, boosting the demand for this medication[1].

Aging Population

An aging population is more susceptible to mental health disorders, leading to an increased demand for treatments like Asenapine Maleate. This demographic trend contributes substantially to the growth of the market[1].

Growing Awareness and Diagnosis

Improved awareness of mental health issues and better diagnostic tools have led to more patients being diagnosed and treated for conditions like schizophrenia and bipolar disorder. This has further boosted the demand for Asenapine Maleate[1].

Generic Drug Market Expansion

As patents for branded drugs expire, there is a growing market for generic versions of Asenapine Maleate. The increasing adoption of generics due to cost-effectiveness drives the API market, making the medication more accessible to a wider population[1].

Regulatory and R&D Factors

Research and Development (R&D) Initiatives

Pharmaceutical companies are investing in R&D to improve the efficacy and safety profile of Asenapine Maleate. Innovations and new formulations can drive market growth by attracting more prescribers and enhancing patient outcomes[1].

Regulatory Approvals and Support

Regulatory approvals for new indications and formulations of Asenapine Maleate can expand its market. Supportive policies and streamlined approval processes by regulatory bodies can also boost market growth[1].

Geographical Market Dynamics

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[1].

Europe

Europe follows closely, characterized by its stringent regulatory environment and a growing recognition of the importance of mental health, leading to a rise in demand for effective antipsychotic medications[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 makes it a vital sub-segment targeted by API manufacturers[1].

Latin America and Middle East & Africa

Latin America presents unique opportunities amid growing healthcare investments, although the market is challenged by economic fluctuations and varying access to medications. The Middle East & Africa segment reflects a complex market landscape with improving mental health awareness but faces hurdles such as healthcare infrastructure deficits and varying degrees of market maturity across countries[1].

Economic and Financial Aspects

Healthcare Expenditure

Growing healthcare spending, particularly in developing regions, is leading to improved access to mental health treatments. This rise in healthcare infrastructure contributes to the growth of the Asenapine Maleate API market[1].

Pharmaceutical Outsourcing

The trend of outsourcing API production to countries with lower manufacturing costs is driving the market. Companies in regions like India and China are major players in the global API market, including Asenapine Maleate[1].

Cost and Pricing Strategies

Asenapine maleate is expensive compared to many other oral antipsychotic drugs, costing approximately £102.60 per month for a typical dosage. However, the presence of multiple players in the market increases competition, which can drive down prices and increase accessibility[2].

Challenges and Volatility

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 Maleate, is approaching saturation. Growth opportunities in these regions may be limited, compelling companies to explore emerging markets[1].

Technological Advancements

Nanostructured Lipid Carriers

Research into nanostructured lipid carriers (NLCs) loaded with Asenapine Maleate aims to increase its oral bioavailability. These formulations have shown enhanced performance both in vitro and in vivo, offering potential for improved patient outcomes and market growth[5].

Key Takeaways

• The Asenapine Maleate API market is driven by increasing prevalence of mental health disorders, an aging population, and growing awareness and diagnosis.
• Regulatory approvals, R&D initiatives, and expanding healthcare expenditure are key factors contributing to market growth.
• Geographical dynamics vary significantly, with North America and Europe leading the market, while the Asia-Pacific region is emerging rapidly.
• Economic factors such as healthcare spending and pharmaceutical outsourcing play crucial roles.
• Challenges include supply chain disruptions and market saturation in developed regions.
• Technological advancements, such as NLCs, offer potential for improved efficacy and market expansion.

FAQs

1. What are the primary indications for Asenapine Maleate?

Asenapine Maleate is primarily indicated for the treatment of moderate to severe manic episodes associated with bipolar disorder and for schizophrenia[2].

2. How is Asenapine Maleate administered?

Asenapine Maleate is administered via sublingual tablets, which must not be chewed or swallowed. It bypasses first-pass metabolism, leading to a rapid onset of action[2].

3. What are the potential side effects of Asenapine Maleate?

Asenapine Maleate has been associated with anaphylactic reactions, and caution is advised in patients with hepatic or renal impairment. It should not be used in patients under 18 years or those with dementia[2].

4. How does the cost of Asenapine Maleate compare to other antipsychotic medications?

Asenapine Maleate is more expensive than many other oral antipsychotic drugs, costing approximately £102.60 per month for a typical dosage[2].

5. What are the future prospects for the Asenapine Maleate market?

The market is expected to grow significantly over the forecast period, driven by increasing prevalence of mental health disorders, R&D initiatives, and expanding healthcare expenditure. However, it faces challenges such as supply chain disruptions and market saturation in developed regions[1][3].

Cited Sources:

1. Verified Market Research - Asenapine Maleate API Market Size, Share, Trends & Forecast
2. NHS - GUIDELINES FOR THE USE OF ASENAPINE MALEATE
3. Market Research Intellect - Global asenapine market size and forecast
4. Market Publishers - 2018 Global Asenapine Maleate Industry Report
5. King's College London - Asenapine maleate loaded nanostructured lipid carriers