saphris Drug Patent Profile

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

Saphris is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in SAPHRIS is asenapine maleate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Saphris

A generic version of saphris was approved as asenapine maleate by ALEMBIC on December 10^th, 2020.

Summary for saphris

US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	64
Clinical Trials:	12
Patent Applications:	77
Drug Prices:	Drug price information for saphris
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for saphris
What excipients (inactive ingredients) are in saphris?	saphris excipients list
DailyMed Link:	saphris at DailyMed

See drug prices for saphris

Recent Clinical Trials for saphris

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

Sponsor	Phase
Amneal Pharmaceuticals, LLC	Phase 2/Phase 3
Accutest Research Laboratories (I) Pvt. Ltd.	Phase 2/Phase 3
University of Louisville	Phase 2

See all saphris clinical trials

Pharmacology for saphris

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for SAPHRIS

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 saphris

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	022117-003	Mar 12, 2015	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	AB	RX	Yes	Yes					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009	AB	RX	Yes	Yes					Y

Expired US Patents for saphris

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

International Patents for saphris

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

Country	Patent Number	Title	Estimated Expiration
Germany	69502939
Brazil	1100625
Finland	963398
Japan	2006342178	SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITION
Mexico	9603713	COMPOSICION FARMACEUTICA SUBLINGUAL O BUCAL. (SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITION.)
Brazil	9506924
Russian Federation	2139051	СУБЛИНГВАЛЬНАЯ ИЛИ ТРАНСБУККАЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (SUBLINGUAL OR TRANSBUCCAL PHARMACEUTICAL COMPOSITION)

Supplementary Protection Certificates for saphris

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0746317	CA 2011 00001	Denmark
0746317	122010000050	Germany		PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
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	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317	SZ 39/2010	Austria
0746317	SPC032/2010	Ireland		SPC032/2010: 20101210, EXPIRES: 20200228
0746317	1090035-5.L	Sweden		PRODUCT NAME: ASENAPIN; REG. NO/DATE: EU/1/10/640/001 20100901

Saphris Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Saphris (Asenapine)

Introduction to Saphris (Asenapine)

Saphris, known generically as asenapine, is a medication used to treat certain mental/mood disorders, including schizophrenia and bipolar disorder. It helps patients think more clearly, feel less nervous, and participate in everyday life by reducing hallucinations and preventing severe mood swings[4].

Market Drivers

Increasing Prevalence of Mental Health Disorders

The global market for Saphris is significantly driven by the increasing prevalence of mental health disorders. As mental health concerns rise, more individuals are seeking treatment, which boosts the demand for medications like Saphris. This trend is particularly pronounced in regions where mental health awareness is growing, encouraging people to seek medical help[1].

Innovation in Drug Delivery

The unique sublingual administration method of Saphris, which offers a rapid onset of action, is another key driver. This method is particularly beneficial in emergency settings, making Saphris a valuable therapeutic option in acute situations[1].

Expanding Clinical Applications

Pharmaceutical companies are investing in research and development to expand the applications of Saphris. This includes exploring its potential in treating other mood disorders and improving its formulation. Such innovations are expected to further propel the market growth of Saphris[1].

Market Size and Growth

Current Market Size

The global schizophrenia drugs market, which includes Saphris, was valued at USD 7.50 billion in 2022. It is projected to grow to USD 11.94 billion by 2031, with a Compound Annual Growth Rate (CAGR) of 5.3% during the forecast period (2024-2031)[3].

Regional Segmentation

The Saphris market is segmented geographically into regions such as North America, Latin America, Western Europe, Eastern Europe, Asia Pacific, and the Middle East and Africa. Each region presents different opportunities and challenges, with North America and Europe being significant markets due to higher awareness and better healthcare infrastructure[4].

Financial Trajectory

Revenue and Profitability

The financial performance of companies involved in the Saphris market, such as Allergan (now part of AbbVie), reflects the market's growth potential. For instance, Allergan's financial reports show significant revenues from their pharmaceutical products, although specific figures for Saphris are not always detailed. However, the overall pharmaceutical segment's performance indicates a stable and growing revenue stream[2][5].

Operating Expenses and Income

Companies in the Saphris market incur substantial operating expenses, including research and development costs, marketing expenses, and amortization. Despite these costs, non-GAAP operating income and adjusted EBITDA for these companies often remain positive, indicating a profitable market. For example, Allergan's non-GAAP operating income and adjusted EBITDA have shown stability and growth over the years[2][5].

Competitive Landscape

The Saphris market is highly competitive, with several large and small vendors competing based on factors such as price, user-friendly interface, value-added benefits, and service benefits. Key players like Allergan (AbbVie), Merck & Co., and Actavis Generics (Teva) are continually developing new technologies and integrating them into their product portfolios to gain a competitive edge[4].

Market Trends

Evolving Understanding of Schizophrenia

The market is experiencing a transformative shift driven by an evolving understanding of the complex mechanisms underlying schizophrenia. Traditional views focusing on dopamine dysregulation are now expanded to include multifaceted structural and chemical abnormalities. This has led to drug development targeting novel pathways such as trace amine-associated receptors (TAARs), muscarinic receptors, and serotonergic receptors, promising safer and more effective therapeutic options[3].

Clinical Studies and Innovations

Ongoing clinical studies aimed at developing innovative drugs are set to address pressing unmet needs in schizophrenia management. Pharmaceutical companies are proactively exploring new therapeutic avenues and strengthening their drug pipelines, which is expected to captivate both healthcare providers and patients, thus propelling the market forward[3].

Challenges and Restraints

Insufficient Awareness and Stigma

Despite the growth potential, the Saphris market faces significant restraints. Insufficient awareness and understanding of mental health issues, particularly in developing countries, along with the stigma associated with mental health disorders, limit treatment accessibility and market demand[3].

High Costs and Adverse Effects

The high costs associated with schizophrenia medications and treatments also limit patient access. Additionally, adverse effects associated with many antipsychotic medications contribute to patients' reluctance to initiate or adhere to treatment regimens, undermining confidence in available therapies[3].

Regulatory and Financial Analysis

Project Economics

For companies setting up a Saphris manufacturing plant, detailed project economics are crucial. This includes analysis of capital expenditure (CapEx), operating expenditure (OpEx), income projections, taxation, depreciation, liquidity analysis, profitability analysis, payback period, Net Present Value (NPV), uncertainty analysis, and sensitivity analysis. Regulatory procedures and approvals, along with financial assistance and required certifications, are also critical components of the setup process[1].

Financial Assistance and Certifications

Financial assistance and comprehensive lists of certifications required for setting up a Saphris manufacturing plant are essential for new entrants. Understanding these aspects helps in navigating the regulatory landscape and ensuring compliance with industry standards[1].

Key Takeaways

• The Saphris market is driven by increasing mental health concerns, innovation in drug delivery, and expanding clinical applications.
• The global schizophrenia drugs market, including Saphris, is projected to grow significantly by 2031.
• The market is highly competitive, with key players focusing on new technologies and value-added benefits.
• Despite growth potential, the market faces challenges such as insufficient awareness, high costs, and adverse effects.
• Detailed project economics and regulatory compliance are crucial for manufacturing plant setups.

FAQs

Q: What is Saphris used for?

Saphris (asenapine) is used to treat certain mental/mood disorders, including schizophrenia and bipolar disorder. It helps patients think more clearly, feel less nervous, and participate in everyday life by reducing hallucinations and preventing severe mood swings[4].

Q: What drives the market growth of Saphris?

The market growth of Saphris is driven by the increasing prevalence of mental health disorders, innovation in drug delivery, and expanding clinical applications[1].

Q: Which regions are significant for the Saphris market?

North America, Latin America, Western Europe, Eastern Europe, Asia Pacific, and the Middle East and Africa are significant regions for the Saphris market, with North America and Europe being particularly important due to higher awareness and better healthcare infrastructure[4].

Q: What are the main challenges facing the Saphris market?

The main challenges include insufficient awareness and understanding of mental health issues, high costs associated with treatments, and adverse effects associated with antipsychotic medications[3].

Q: Who are the key players in the Saphris market?

Key players in the Saphris market include Allergan (AbbVie), Merck & Co., and Actavis Generics (Teva)[4].

Sources

1. IMARC Group: Asenapine (Saphris) Manufacturing Plant Report 2024.
2. Allergan: Allergan Reports Second Quarter 2019 Financial Results.
3. SkyQuest: Schizophrenia Drugs Market Size, Share, Growth Analysis.
4. OpenPR: Saphris (Asenapine) Market Progresses for Huge Profits by 2025.
5. Allergan: Allergan Reports Fourth Quarter and Full-Year 2018 Financial Results.