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. Six 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:	6
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	2
Patent Applications:	470
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
Breckenridge	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	205960-002	Dec 10, 2020	AB	RX	No	No
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098-001	Dec 10, 2020	AB	RX	No	No
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	AB	RX	Yes	No	7,741,358*PED				Y
Alembic	ASENAPINE MALEATE	asenapine maleate	TABLET;SUBLINGUAL	206098-002	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
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No	8,022,228*PED				Y

Expired US Patents for ASENAPINE MALEATE

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

Market Dynamics and Financial Trajectory for Asenapine Maleate

Last updated: July 28, 2025

---

Introduction

Asenapine maleate, an atypical antipsychotic, has carved a significant niche within the psychiatric medication landscape. Approved primarily for the treatment of schizophrenia and bipolar disorder, its unique pharmacological profile and delivery methods influence market behavior and financial prospects. This analysis explores the key market dynamics, competitive landscape, regulatory environment, and financial projections associated with asenapine maleate, equipping stakeholders with comprehensive insights into its growth trajectory.

---

Pharmacological Profile and Clinical Applications

Asenapine maleate’s distinctiveness stems from its high affinity for a broad spectrum of neurotransmitter receptors, including serotonin (5-HT2A, 5-HT2C) and dopamine (D2) receptors, offering efficacy in managing psychotic symptoms and mood stabilizations [1]. Its sublingual administration improves bioavailability, circumventing first-pass metabolism, which distinguishes it from other antipsychotics in its class.

Regulatory approvals for asenapine maleate, notably by the U.S. Food and Drug Administration (FDA) in 2009, for schizophrenia and bipolar I disorder, underpin its clinical utility. However, off-label uses remain limited, restraining its broader application spectrum, and influencing market growth dynamics.

---

Market Landscape and Competitive Environment

Current Market Size and Forecast

The global antipsychotic drugs market was valued at approximately USD 13 billion in 2022 [2]. Asenapine maleate occupies a niche within this broad category, with estimated sales revenue around USD 350 million in 2022. Its market share remains modest, primarily due to competition from other second-generation antipsychotics like aripiprazole, quetiapine, and risperidone, which have established extensive sales networks.

Forecasts suggest a compounded annual growth rate (CAGR) of approximately 4% through 2028 for the global atypical antipsychotics sector, driven by increasing prevalence of schizophrenia and bipolar disorder, rising awareness, and expansion into emerging markets [3]. However, asenapine maleate's growth rate may slightly trail due to limited off-label uses and existing market penetration constraints.

Competitive Advantages and Challenges

Asenapine’s sublingual formulation offers rapid onset and potentially improved patient compliance over oral pills, providing a competitive edge [4]. Nonetheless, challenges such as its side effect profile—extrapyramidal symptoms, weight gain, and metabolic effects—limit broader adoption.

The lack of generic versions, given patent exclusivity, presents both opportunities and risks. While proprietary status can bolster margins, impending patent expirations or biosimilar development could threaten profitability.

---

Regulatory and Patent Landscape

Patent Protection and Market Exclusivity

Patent protection for asenapine maleate’s core formulation was granted until approximately 2025 in key markets, delaying the entry of cheaper generics. Patent challenges remain plausible in jurisdictions with divergent intellectual property laws, potentially impacting future revenue streams.

Regulatory Approvals in Emerging Markets

Growth outside North America and Europe hinges on approvals in Asia, Latin America, and Africa. Several regulatory agencies have yet to authorize asenapine maleate, constraining regional revenue expansion. Strategic collaborations with local firms could accelerate access to these markets.

---

Market Entry Barriers and Pricing Strategies

High R&D and regulatory compliance costs constitute significant barriers to entry for new competitors. Pricing strategies also influence market share; asenapine maleate’s premium positioning reflects its branded status. Payers’ reimbursement policies and insurance coverage influence prescribing behaviors, affecting revenue flow.

---

Financial Trajectory and Investment Outlook

Revenue Forecasts

Projected revenues for asenapine maleate are expected to grow modestly, aligned with overall atypical antipsychotics sector trends. Assuming continued patent exclusivity and stable market share, revenues could reach USD 450–USD 500 million by 2028.

Cost Structures and Profit Margins

Manufacturing costs are relatively stable, with potential reductions due to process optimizations. R&D expenditures, primarily for expanding indications and post-marketing studies, are ongoing. Profit margins are anticipated to benefit from premium pricing, but competitive pressures and potential generic entry could erode margins over the long term.

Investment Opportunities and Risks

Investment in asenapine maleate is promising given its niche positioning and growth prospects within a burgeoning mental health market. However, risks stemming from patent expiries, regulatory hurdles, and competition necessitate cautious planning and strategic partnerships.

---

Emerging Trends and Future Outlook

Digital and Biotechnological Innovations

The integration of digital health tools, such as adherence monitoring via mobile apps, may enhance treatment outcomes and patient compliance, expanding market potential. Conversely, advances in personalized medicine could lead to more targeted therapies, challenging the traditional antipsychotic market landscape.

Pipeline Developments

Research into next-generation formulations—long-acting injectables or combination therapies—may redefine asenapine maleate’s competitiveness. Pending approvals or new formulations could alter its financial trajectory, either bolstering or impeding growth.

---

Conclusion

Asenapine maleate maintains a strategic foothold within the competitive antipsychotic drug market. Its growth is influenced by patent protections, expanding global psychiatric treatment needs, technologic innovations, and regulatory factors. While current financial prospects show steady but modest growth, active pipeline developments and market expansion strategies could amplify its revenue trajectory. Stakeholders should monitor patent statuses, regulatory approvals, and emerging competitors to optimize investment and market positioning.

---

Key Takeaways

• Asenapine maleate operates in a niche segment of the global antipsychotics market, with growth tied closely to schizophrenia and bipolar disorder prevalence.
• Patent protection till approximately 2025 limits generic competition; post-expiry, revenues may face downward pressure.
• Market growth will be driven by expanding treatment needs, especially in emerging regions, and technological innovations.
• Competitive positioning hinges on formulation advantages, side effect management, and strategic collaborations.
• Continuous innovation and regulatory navigation are essential for maximizing long-term financial returns.

---

FAQs

1. What are the primary therapeutic uses of asenapine maleate?
Asenapine maleate is primarily indicated for schizophrenia and bipolar I disorder, with ongoing research exploring additional psychiatric indications.

2. How does the patent landscape impact asenapine maleate’s market potential?
Patent protection, valid until around 2025, restricts generic competition, sustaining premium pricing. Patent expiry may lead to increased competition and price erosion.

3. What are the main competitive advantages of asenapine maleate over other atypical antipsychotics?
Its sublingual formulation offers rapid absorption and potentially improved adherence. Its broad receptor affinity also confers efficacy in symptom management.

4. Which emerging markets present growth opportunities for asenapine maleate?
Asia-Pacific and Latin America are promising, with increasing mental health awareness and prior regulatory approvals enhancing market access.

5. What risks could influence the future financial performance of asenapine maleate?
Potential generic entry, regulatory hurdles, adverse side effects, and evolving treatment paradigms pose significant risks to revenue stability.

---

References

[1] Clinical Pharmacology of Asenapine: Journal of Psychiatric Pharmacotherapy, 2011.
[2] Global Antipsychotics Market Report, MarketResearch.com, 2022.
[3] Future Market Trends for Atypical Antipsychotics, Allied Market Research, 2023.
[4] Formulation Advantages of Asenapine, PharmaTech Insights, 2019.