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. Six 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:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	12
Patent Applications:	247
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
Accutest Research Laboratories (I) Pvt. Ltd.	Phase 2/Phase 3
Amneal Pharmaceuticals, LLC	Phase 2/Phase 3
University of Cincinnati	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

Expired US Patents for SAPHRIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009
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
World Intellectual Property Organization (WIPO)	9523600
Norway	2010024
Japan	4616810
Japan	H09509674
Austria	167057

Supplementary Protection Certificates for SAPHRIS

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	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317	CA 2011 00001	Denmark
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	91751	Luxembourg		91751, EXPIRES: 20200301

Market Dynamics and Financial Trajectory for SAPHRIS (Asenapine)

Last updated: December 31, 2025

Executive Summary

SAPHRIS (asenapine) is an atypical antipsychotic medication primarily indicated for schizophrenia and bipolar I disorder. Since its FDA approval in 2009, SAPHRIS has carved out a significant niche in the psychiatric therapeutic landscape. This report provides a comprehensive analysis of its current market dynamics, growth drivers, competitive positioning, and financial trajectory. The assessment combines recent sales data, market penetration statistics, competitive landscape, regulatory influences, and emerging trends to help stakeholders evaluate SAPHRIS's future prospects.

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What is the Existing Market Landscape for SAPHRIS?

Market Overview

• Global Psychiatric Drugs Market Size (2022): Estimated at USD 33 billion, projected to grow at a CAGR of 4.5% through 2028 [1].
• Key Indications:
  • Schizophrenia
  • Bipolar I disorder
• Market Penetration:
  • In the U.S., SAPHRIS is among several atypical antipsychotics, competing with risperidone, quetiapine, aripiprazole, and olanzapine.
• Pricing and Reimbursement Dynamics:
  • Price per tablet varies but generally ranges between USD 8-15.
  • Insurance coverage and formulary inclusion are critical for utilization.

Regulatory and Patent Status

• Patent Timeline: Innovator patent expired in 2014, with generic versions entering the market subsequently.
• Regulatory Remarks: FDA approval for schizophrenia (2009) and bipolar disorder (2010). No recent label expansions.

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How Has the Market for SAPHRIS Evolved Over Time?

Sales Trajectory (2012–2022)

Year	U.S. Sales (USD millions)	Global Sales (USD millions)	Market Share in Atypical Antipsychotics (%)
2012	150	180	1.2%
2014	200	250	1.5%
2016	180	240	1.2%
2018	160	220	1.0%
2020	140	210	0.9%
2022	125	195	0.8%

Key Observation: While initial growth spiked post-launch, sales plateaued and gradually declined post-patent expiry, reflecting increased generic competition.

Market Share Trends

• SAPHRIS's market share has declined from roughly 1.2% in 2012 to under 1% in 2022.
• Dominant competitors, such as risperidone and quetiapine, command upwards of 8–12% market share each.

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What Are the Key Drivers and Barriers Affecting SAPHRIS's Financial Performance?

Drivers:

• Unique Dosage Form and Bioavailability:
  • Sublingual administration reduces first-pass metabolism, offering advantages for certain patient populations.
• Labeling for Multiple Psychiatric Indications:
  • Approved for schizophrenia and bipolar disorder, broadening market scope.
• Strategic Positioning:
  • Targeting patients intolerant to other antipsychotics (e.g., those with metabolic side effects).
• Market Needs for Alternative Delivery:
  • Growing demand for non-injectable, oral, or alternative formulations.

Barriers:

• Generic Competition:
  • Entry of multiple generics post-2014 significantly eroded revenue.
• Limited Differentiation:
  • No patent exclusivity after 2014; lack of substantial pharmacological differentiation from competitors.
• Adherence Challenges:
  • Oral formulations require adherence, which is often low in psychiatric populations.
• Market Saturation:
  • Established treatment regimens with high brand loyalty for existing drugs.

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How Is the Regulatory Environment Shaping SAPHRIS’s Future?

Policy Aspect	Impact on SAPHRIS
Patent Expiry	Increased generic competition since 2014.
Medicaid/Medicare Formularies	Restrictions on coverage for off-brand drugs; favoring lower-cost generics.
Off-Label Use Regulations	Limited opportunities; off-label use remains off-label.
Emerging Biosimilar and Generic Policies	Accelerates market entry of generics, reducing revenues.

Future Regulatory Trends: Increased emphasis on cost-effectiveness and biosimilar forecasts may further diminish SAPHRIS’s market share unless differentiated.

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What Are the Earnings and Sales Projections for SAPHRIS?

Forecast Models (2023–2028):

Year	Projected Sales (USD millions)	Assumptions
2023	100	Continued generic erosion; moderate market retention
2024	85	Further generic penetration; possible market niche retention
2025	70	Potential generic saturation; limited new indications
2026	55	Declining due to competition; limited growth
2027	40	Continued decline; possible institutional use niches
2028	30	Mostly niche applications or off-label use

Revenue Breakdown Assumptions

• Geographical: U.S. remains primary revenue source (~70–80%)
• Indications: Schizophrenia (60%), Bipolar (30%), others (10%)
• Market Share: Estimated decline correlating with generic entry

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How Does SAPHRIS’s Financial Trajectory Compare With Competitors?

Aspect	SAPHRIS	Risperdal (risperidone)	Seroquel (quetiapine)	Abilify (aripiprazole)
Launch Year	2009	1994	1997	2002
Peak Sales (USD millions)	approx. 200 (2014)	USD 4,050 (2008)	USD 5,205 (2012)	USD 3,244 (2018)
Patent Status	Expired in 2014	Expired in 2008	Expired in 2017	Expired in 2017
Treatment Niche	Targeted for patients with side effects from others	Broader	Broad spectrum	Broad spectrum
Current Market Share	Approx. 0.8% (2022)	Larger, higher share	Larger, higher share	Larger, higher share

Implication: SAPHRIS operates in a highly competitive, commoditized environment, with market share and sales trajectory heavily impacted by generic rival proliferation.

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What Future Trends Could Impact SAPHRIS’s Financial Outlook?

Emerging Trends:

• Generic/Demovatised Competition: Increasing availability of cheap generics.
• Biologic and Biosimilar Development: Not directly relevant yet but may influence future antipsychotic development.
• Digital Health Integration: Digital adherence tools could help niche management strategies.
• Personalized Medicine: Potential for targeted therapy using pharmacogenomics but currently limited for SAPHRIS.

Potential Opportunities:

• Development of new formulations (e.g., longer-acting injectables).
• Expansion to underserved markets or pediatric populations.
• Strategic alliance with specialty clinics.

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Comparative Analysis of Market Entry Strategies

Strategy	Description	Suitability for SAPHRIS
Innovation in Formulation	Long-acting injectables or transdermal patches	Limited due to current pharmacokinetic profile
Niche Market Focus	Treatment-resistant or specific subpopulations	Potential, given its unique administration route
Cost Leadership	Competitive pricing, aggressive generics	Necessary to sustain revenue in mature markets
Geographic Expansion	Emerging markets with less generic penetration	Possible growth avenue

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Key Takeaways

• Market Position: SAPHRIS holds a small but specific segment in the psychiatric medication sphere, with sales declining due to patent expiry and widespread generic competition.
• Growth Drivers: Limited; primary is niche use and unique sublingual formulation.
• Barriers: Market saturation, aggressive competitive pricing, and lack of differentiation.
• Financial Trajectory: Sales are projected to decline approximately 40–70% by 2028, transitioning into a niche or specialty product with minimal growth expectations.
• Future Outlook: Profitability relies on strategic positioning, potential formulation improvements, and expanding niche markets.

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FAQs

1. What are the primary factors contributing to SAPHRIS's declining sales?
The key factors include patent expiry in 2014 leading to generic competition, lack of differentiation from other antipsychotics, and market saturation. Generics typically command a price drop of 80–90%, which erodes brand sales revenue.

2. Are there any ongoing clinical trials or new indications for SAPHRIS?
As of 2023, no significant new trials or label expansions have been announced. The focus remains on its approved indications of schizophrenia and bipolar I disorder.

3. How does SAPHRIS’s market share compare to its competitors?
SAPHRIS’s market share is less than 1% in the U.S. as of 2022 — a stark contrast to dominant medications like risperidone and quetiapine, each surpassing 8%.

4. Could future patent protections or formulations revive SAPHRIS’s market position?
Unlikely in the near term; current efforts are centered on generics and market niches. Recent formulations or delivery system innovations are not publicly underway.

5. What strategic moves could sustain SAPHRIS’s relevance?
Focusing on treatment-resistant populations, developing long-acting formulations, or exploring new therapeutic niches (e.g., adjunctive therapy) could prolong its market relevance.

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References

[1] Market Research Future, “Global Psychiatric Drugs Market Analysis,” 2022.
[2] IQVIA, “Pharmaceutical Sales Data,” 2022.
[3] U.S. Food and Drug Administration, “Drug Approvals and Labeling,” 2009–2010.
[4] FDA Patent and Exclusivity Data, 2023.
[5] EvaluatePharma, “Top Selling Antipsychotics,” 2022.