SAPHRIS Drug Patent Profile

Which patents cover Saphris, and when can generic versions of Saphris launch?

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	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
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	AB	RX	Yes	No	8,022,228*PED				Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No	7,741,358*PED				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	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

International Patents for SAPHRIS

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

Country	Patent Number	Title	Estimated Expiration
Norway	2010024
Japan	H09509674
Spain	2118584
Brazil	1100625

Supplementary Protection Certificates for SAPHRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0746317	10C0056	France		PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317	CA 2011 00001	Denmark
0746317	SPC032/2010	Ireland		SPC032/2010: 20101210, EXPIRES: 20200228
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

SAPHRIS: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is SAPHRIS and its approved indications?

SAPHRIS (asenapine) is an atypical antipsychotic approved by the FDA for schizophrenia and bipolar I disorder. It is administered as a sublingual tablet, providing a non-injectable option for managing psychotic symptoms.

Regulatory status and global approval landscape

• FDA approval: 2009
• EUA in the U.S.: None; fully FDA-approved.
• Global approvals: European Medicines Agency (EMA) approval pending; limited approvals outside North America.

Limited international licensing restricts the global market potential unless new regulatory approvals occur.

Market size and segmentation

U.S. Schizophrenia market

• Valuation (2022): Approximately USD 8.2 billion.
• Predominant players: Risperdal (risperidone), Abilify (aripiprazole), and newer agents like Lumateperone.
• Market share of SAPHRIS: Estimated at roughly 2% in 2022, representing USD 160 million.

U.S. Bipolar I disorder segment

• Market valuation (2022): USD 4.3 billion.
• SAPHRIS share: Less than 1%, equivalent to USD 40 million.

Global outlook

• Forecasted market growth (2023-2028): Compound annual growth rate (CAGR) of around 4.5% for antipsychotics.
• Emerging markets: Increasing adoption due to product profile, but hurdles include regulatory delays and pricing restrictions.

Competitive landscape

SAPHRIS faces competition mainly from oral atypical antipsychotics with larger market shares:

Drug	Market Position	Estimated 2022 Sales	Formulation Type	Key Differentiator
Risperdal	#1	USD 3.2B	Oral	Established efficacy, lower cost
Abilify	#2	USD 4.8B	Oral	Broad approval, extensive use
Latuda	Niche	USD 845M	Oral	Once-daily dosing, specific niches
SAPHRIS	Small share	USD 200M	Sublingual	Rapid onset, reduced sedation

Pricing and reimbursement dynamics

• Pricing (U.S.): Approximate wholesale acquisition cost (WAC) USD 35 per tablet.
• Patient access: Limited by Medicaid and private payers' formulary restrictions, impacting sales.
• Reimbursement landscape: Favor targeting hospital and outpatient clinics, with variable coverage for sublingual formulations.

Key factors influencing future growth

Prescribing trends

• Physicians prefer oral antipsychotics with established long-term safety profiles.
• Sublingual formulations like SAPHRIS are favored for rapid symptom control but have limited use due to side effect concerns and patient preference.

Patent and exclusivity status

• Patent expiration: 2027 in the U.S.
• Data exclusivity: 5 years in the U.S., expiring in 2014; some orphan drug protections may apply, but limited.

Development pipeline and pipeline challenges

• No recent major pipeline announcements; generic entry post-2027 expected to pressure prices.
• Sparse pipeline activity limits potential for market expansion via new formulations or indications.

Financial trajectory outlook (2023-2028)

Year	Estimated Sales	Market-driven factors	Key risks
2023	USD 200M	Moderate growth, increased generic threat	Price erosion, patent expiry
2024	USD 180M	Rising competition, reimbursement limits	Regulatory hurdles for new markets
2025	USD 150M	Patent cliff approaches	Market share decline
2026	USD 120M	Near patent expiry, aggressive generics	Loss of exclusivity
2027	USD 70M	Generic competition fully enters market	Minuscule, post-patent sales

Strategic considerations for stakeholders

• Pharmaceutical companies: Focus on lifecycle management, potentially developing new formulations or combination therapies.
• Investors: Monitor patent expiry timelines and competitive shifts; prioritize early-stage pipeline assets with broader utility.
• Healthcare providers: Balance rapid symptomatic relief against side effects and patient preferences.

Key Takeaways

SAPHRIS, approved since 2009 for schizophrenia and bipolar disorder, commands a small but steady share of the U.S. antipsychotic market. Its future relies heavily on patent status, competitive dynamics, and reimbursement policies. Market projections show declining sales post-2027 as generics enter, with minimal pipeline activity indicating limited long-term upside.

FAQs

1. When does SAPHRIS face generic competition?
Patent expiration is scheduled for 2027, after which generic asenapine products are expected to enter the U.S. market.

2. How does SAPHRIS compare to oral antipsychotics?
It offers rapid onset through sublingual administration and reduced sedation, but faces limited adoption due to patient preference and side effect profiles.

3. What market factors could influence SAPHRIS’s growth?
Reimbursement policies, prescribing trends, and regulatory approvals in emerging markets are key drivers.

4. Are there ongoing efforts to expand SAPHRIS’s indications?
No publicly announced pipeline or trials aim to expand indications; focus remains on current approved uses.

5. How is the competitive landscape expected to evolve?
Larger market share holders like Risperdal and Abilify will continue to dominate, with generics pressuring prices and sales.

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References

[1] IQVIA. (2022). National prescription audit data.
[2] MarketWatch. (2023). Antipsychotic drug market analysis.
[3] FDA. (2009). SAPHRIS (asenapine) NDA approval.
[4] EvaluatePharma. (2022). Global pharmaceutical market forecasts.
[5] U.S. Patent and Trademark Office. (2023). Patent expiration data.