CAPLYTA Drug Patent Profile

Which patents cover Caplyta, and what generic alternatives are available?

Caplyta is a drug marketed by Intra-cellular and is included in one NDA. There are twenty-five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six patent family members in twenty countries.

The generic ingredient in CAPLYTA is lumateperone tosylate. One supplier is listed for this compound. Additional details are available on the lumateperone tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Caplyta

Caplyta was eligible for patent challenges on December 20, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 30, 2039. This may change due to patent challenges or generic licensing.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (lumateperone tosylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for CAPLYTA

International Patents:	176
US Patents:	25
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	3
Drug Prices:	Drug price information for CAPLYTA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CAPLYTA
What excipients (inactive ingredients) are in CAPLYTA?	CAPLYTA excipients list
DailyMed Link:	CAPLYTA at DailyMed

See drug prices for CAPLYTA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CAPLYTA

NDA:

209500

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for CAPLYTA

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

Sponsor	Phase
University of Massachusetts, Worcester	Phase 4
Intra-Cellular Therapies, Inc.	Phase 4
University of New Mexico	Phase 4

See all CAPLYTA clinical trials

Pharmacology for CAPLYTA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for CAPLYTA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CAPLYTA	Capsules	lumateperone tosylate	42 mg	209500	7	2023-12-20

US Patents and Regulatory Information for CAPLYTA

CAPLYTA is protected by thirty-three US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes			Y	Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No			Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes					Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes			Y
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019		RX	Yes	Yes
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-003	Apr 22, 2022		RX	Yes	No			Y

Expired US Patents for CAPLYTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019
Intra-cellular	CAPLYTA	lumateperone tosylate	CAPSULE;ORAL	209500-001	Dec 20, 2019

International Patents for CAPLYTA

When does loss-of-exclusivity occur for CAPLYTA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CAPLYTA around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2020012868	METODOS Y COMPOSICIONES PARA TRASTORNOS DEL SUE?O Y OTROS TRASTORNOS. (METHODS AND COMPOSITIONS FOR SLEEP DISORDERS AND OTHER DISORDERS.)
Japan	6475727
China	118873536	新方法 (Novel method)
Canada	3148326
Canada	2716730	SOLIDE DE GAMMA-CARBOLINES FUSIONNEES A HETEROCYCLES SUBSTITUES (SUBSTITUTED HETEROCYCLE FUSED GAMMA-CARBOLINES SOLID)
Brazil	0012084
Russian Federation	2682658

Market Dynamics and Financial Trajectory for CAPLYTA

Last updated: July 27, 2025

Introduction

CAPLYTA (lumateperone) represents a significant advancement in the treatment of schizophrenia and bipolar depression, marketed by Sumitomo Dainippon Pharma and its U.S. subsidiary, Intra-Cellular Therapies. Since its FDA approval in December 2019, the drug has navigated complex market dynamics influenced by regulatory landscapes, competitive environment, clinical efficacy, and emerging indications. This analysis explores the current market environment for CAPLYTA, its sales trajectory, growth forecasts, competitive positioning, and strategic considerations shaping its future.

Regulatory Milestones and Approval Landscape

CAPLYTA received FDA approval in December 2019 for schizophrenia in adults, establishing a foothold in the bipolar disorder segment in early 2020. The approval was supported by Phase 3 trials demonstrating the drug’s efficacy and tolerability profile comparable or superior to existing antipsychotics. Notably, the drug's unique mechanism of action as a serotonin and dopamine modulator distinguishes it from traditional antipsychotics, potentially broadening its clinical appeal.

Regulatory dynamics continue to shape market penetration. The company has sought approval for additional indications, notably bipolar depression, which received FDA clearance in 2021. The extension into bipolar depression opens a new revenue stream, although the drug's market share will depend on the competitive response and clinician adoption patterns.

Market Size and Segmentation

Schizophrenia Market

According to the National Institute of Mental Health, approximately 1 million individuals in the U.S. live with schizophrenia, with an estimated 50% untreated or inadequately managed [1]. Globally, the market exceeds several billion dollars, with the U.S. accounting for roughly 40% of total sales.

Bipolar Disorder and Depression

The bipolar disorder segment is estimated at $4.4 billion in the U.S., with bipolar depression accounting for a sizable proportion. The expanding label for bipolar depression positions CAPLYTA to target an underserved niche, with potential to capture significant market share owing to its favorable side effect profile.

Market Drivers and Constraints

Key drivers include increasing prevalence, heightened awareness, expanding indications, and the aging population. Constraints involve existing competition from established antipsychotics and mood stabilizers, regulatory hurdles for new indications, and physician familiarity with competitors.

Competitive Landscape

CAPLYTA operates within a highly competitive ecosystem comprising both first-generation and second-generation antipsychotics, as well as emerging therapies:

• Traditional antipsychotics (e.g., haloperidol) are well-established but have unfavorable side-effect profiles.
• Atypical antipsychotics (e.g., risperidone, olanzapine, aripiprazole) dominate the market with higher sales, though they pose risks related to weight gain, metabolic disturbances, and extrapyramidal symptoms.
• Emerging drugs include pimavanserin and brexpiprazole, offering alternative mechanisms with different efficacy and tolerability profiles.

CAPLYTA's positioning hinges on its novel mechanism, which may translate into improved side-effect profiles and better adherence, impacting its market share trajectory.

Sales Trajectory and Revenue Estimates

Initial Performance

Intra-Cellular Therapies disclosed that in 2020, CAPLYTA generated approximately $4.4 million in net product sales, indicating modest initial uptake [2]. This conservative figure reflects typical early-phase commercial performance, including limited prescriber familiarity, insurance coverage hurdles, and distribution challenges.

Growth Trends and Projections

By Q2 2022, sales had increased substantially, reaching approximately $25 million, driven by broader insurance coverage, strategic marketing efforts, and gradual acceptance [3]. Analysts project that, with expanded indications and increased market penetration, sales could surpass $200 million annually by 2025.

Factors Influencing Revenue Growth

• Indication Expansion: FDA approval for bipolar depression and potential future labels (e.g., schizophrenia maintenance, treatment-resistant depression) can catalyze growth.
• Market Penetration Strategies: Collaborations with key payers, clinician education, and formulary placements are critical.
• Pricing Strategy: As a novel agent, premium pricing may initially be sustainable but could face pressure from payers and competing generics.

Risk Considerations

Potential barriers include delayed approval for additional indications, market entry of competing therapies, safety concerns, and reimbursement challenges—factors that could temper revenue growth or prolong time to full market potential.

Strategic Opportunities and Challenges

Opportunities

• Unmet Need Targeting: CAPLYTA’s improved tolerability profile offers significant appeal for patients intolerant to side effects of older antipsychotics.
• Adjunctive and Expanded Indications: Future trials exploring augmentation in major depressive disorder could unlock further revenue streams.
• Global Expansion: Developing markets present additional growth avenues, contingent on regulatory approvals.

Challenges

• Competitive Saturation: Gaining physician trust and market share against entrenched medications remains a hurdle.
• Pricing and Reimbursement: Balancing premium pricing with payer acceptance influences profitability.
• Manufacturing Scalability: Ensuring supply chain robustness is crucial to meet growing demand.

Financial Outlook and Investment Considerations

Intra-Cellular Therapies continues investing in clinical trials and medical education, impacting short-term profitability but laying groundwork for long-term expansion. The company’s financial reports indicate steady revenue growth, with potential for acceleration if expansion plans materialize successfully.

Investors should monitor:

• Sales data updates for real-world uptake.
• Pipeline developments for new indications.
• Regulatory developments in key markets outside the U.S.
• Competitive actions by proprietary and generic players.

Conclusion

CAPLYTA’s market trajectory hinges on its ability to expand indications and penetrate competitive environments effectively. Its recent sales momentum signifies initial acceptance, with substantial growth potential as broadening usage and clinician familiarity increases. Strategic focus on reimbursement, clinical differentiation, and global expansion will be paramount over the next 3–5 years.

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Key Takeaways

• Market potential remains substantial within schizophrenia and bipolar disorder, with an expanding pipeline and indications.
• Early sales figures demonstrate steady growth, but long-term success depends on market access, prescriber adoption, and competitive differentiation.
• Regulatory approvals and clinical data supporting expanded use will be pivotal.
• Pricing and reimbursement strategies will significantly influence revenue trajectories.
• Competitor activity and emerging therapies could impact market share; proactive positioning is essential.

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FAQs

1. How does CAPLYTA differ from traditional antipsychotics?
CAPLYTA (lumateperone) employs a novel serotonergic and dopaminergic modulation mechanism, offering a potentially improved side-effect profile, especially regarding metabolic adverse effects and extrapyramidal symptoms.

2. What are the primary markets driving CAPLYTA's growth?
The U.S. remains the leading market due to its large patient base, robust healthcare infrastructure, and regulatory approvals. Expansion into European and Asian markets depends on subsequent regulatory clearances.

3. What obstacles could impede CAPLYTA’s market penetration?
Key barriers include clinician familiarity with established therapies, reimbursement hurdles, competition from generics, and potential safety concerns leading to negative prescribing trends.

4. Are there plans for further indications?
Yes, Intra-Cellular has ongoing trials for additional indications such as maintenance treatment for schizophrenia and possibly depression, which could significantly expand market opportunity if approved.

5. How does pricing influence CAPLYTA’s adoption?
Pricing strategies must balance profitability with payer acceptance; high upfront costs could hinder rapid adoption unless justified by superior efficacy or safety benefits.

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References

[1] National Institute of Mental Health. Schizophrenia. Available at: https://www.nimh.nih.gov/health/statistics/schizophrenia
[2] Intra-Cellular Therapies. 2020 Financial Results.
[3] Analyst Reports, Q2 2022 Earnings Call Transcripts.