INVEGA TRINZA Drug Patent Profile

When do Invega Trinza patents expire, and when can generic versions of Invega Trinza launch?

Invega Trinza is a drug marketed by Janssen Pharms and is included in one NDA. There is one patent protecting this drug and three Paragraph IV challenges.

This drug has fifty-eight patent family members in twenty-seven countries.

The generic ingredient in INVEGA TRINZA is paliperidone palmitate. There are thirty-eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paliperidone palmitate profile page.

DrugPatentWatch^® Generic Entry Outlook for Invega Trinza

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 five tentative approvals for the generic drug (paliperidone palmitate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for INVEGA TRINZA

International Patents:	58
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Patent Applications:	382
Drug Prices:	Drug price information for INVEGA TRINZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INVEGA TRINZA
What excipients (inactive ingredients) are in INVEGA TRINZA?	INVEGA TRINZA excipients list
DailyMed Link:	INVEGA TRINZA at DailyMed

See drug prices for INVEGA TRINZA

Pharmacology for INVEGA TRINZA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for INVEGA TRINZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	273 mg/0.875 mL and 410 mg/1.315 mL	207946	1	2021-07-14
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	819 mg/2.625 mL	207946	1	2021-04-30
INVEGA TRINZA	Extended-release Injectable Suspension	paliperidone palmitate	546 mg/1.75 mL	207946	1	2020-06-24

US Patents and Regulatory Information for INVEGA TRINZA

INVEGA TRINZA is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes

Expired US Patents for INVEGA TRINZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015

International Patents for INVEGA TRINZA

When does loss-of-exclusivity occur for INVEGA TRINZA?

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

Australia

Brazil

Canada

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Finland

Hong Kong

Hungary

Israel

Japan

Lithuania

Moldova, Republic of

Morocco

New Zealand

Poland

Portugal

San Marino

Serbia

Slovenia

South Korea

Spain

Taiwan

Ukraine

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 INVEGA TRINZA around the world.

Country	Patent Number	Title	Estimated Expiration
Croatia	P970276	AQUEOUS SUSPENSION OF 9-HYDROXYRISPERIDONE FATTY ACID ESTERS
Israel	309340	משטר מינון עבור מינונים חסרים של פליפרידון אסטרים הניתנים להזרקה עם פעילות ארוכת טווח (Dosing regimen for missed doses for long-acting injectable paliperidone esters)
Poland	3744326
Taiwan	202222318	Dosing regimens associated with extended release paliperidone injectable formulations

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	CA 2011 00020	Denmark
0368388	SPC/GB07/065	United Kingdom		PRODUCT NAME: PALIPERIDONE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/07/395/001 20070625; UK EU/1/07/395/002 20070625; UK EU/1/07/395/003 20070625; UK EU/1/07/395/004 20070625; UK EU/1/07/395/005 20070625; UK EU/1/07/395/006 20070625; UK EU/1/07/395/007 20070625; UK EU/1/07/395/008 20070625; UK EU/1/07/395/009 20070625; UK EU/1/07/395/010 20070625; UK EU/1/07/395/011 20070625; UK EU/1/07/395/012 20070625; UK EU/1/07/395/013 20070625; UK EU/1/07/395/014 20070625; UK EU/1/07/395/015 20070625; UK EU/1/07/395/016 20070625; UK EU/1/07/395/017 20070625; UK EU/1/07/395/018 20070625; UK EU/1/07/395/019 20070625; UK EU/1/07/395/020 20070625; UK EU/1/07/395/021
0904081	C300491	Netherlands		PRODUCT NAME: PALIPERIDONPALMITAAT; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0904081	C00904081/01	Switzerland		PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215

Market Dynamics and Financial Trajectory for INVEGA TRINZA

Last updated: December 26, 2025

Executive Summary

INVEGA TRINZA (paliperidone palmitate extended-release injectable suspension) is a long-acting atypical antipsychotic used primarily for schizophrenia maintenance therapy. As a critical component within the antipsychotic segment, INVEGA TRINZA's market dynamics are shaped by evolving psychiatric treatment paradigms, competitive landscape, regulatory policies, and payer strategies. This report provides a comprehensive analysis of its current market position, revenue trajectory, competitive environment, legislative influences, and forecasts, offering actionable insights for stakeholders.

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What are the Core Market Drivers for INVEGA TRINZA?

Driver	Impact	Details
Rising Prevalence of Schizophrenia	High	WHO estimates 20 million affected globally (2019), with U.S. prevalence at ~1.1%)^[1]^
Increasing Adoption of Long-Acting Injectables (LAIs)	Moderate to High	LAIs observed to improve adherence, reduce relapse rates^[2]^
Advancements in Pharmacovigilance	Moderate	Enhanced safety monitoring expands patient acceptance^[3]^
Pricing and Reimbursement Policies	Variable	Reimbursement levels influence prescribing habits^[4]^
Competitive Innovation & Launches	High	Novel agents and biosimilars impacting market share^[5]^

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How Does INVEGA TRINZA Perform Within the Pharmaceutical Market?

Market Share & Revenue Trends

Parameter	2020	2021	2022 (Est.)	2023 (Forecast)	Notes
Global Schizophrenia Market (USD Billion)	10.4	11.3	12.2	13.1	CAGR: 7.4% (2020–2023)^[6]^
INVEGA TRINZA Revenue (USD Million)	350	400	470	520	Assumed steady growth with market expansion^[7]^
Market Share (Antipsychotics segment)	2.6%	3.0%	3.4%	3.9%	Driven by increased acceptance of LAIs

Geographic Performance

Region	2022 Revenue (USD Million)	Key Drivers	Outlook
North America	250	High prevalence, reimbursement, formulary access	Continued growth expected
Europe	130	Expanding acceptance, NHSE policies	Moderate growth anticipated
Asia-Pacific	50	Emerging market, infrastructure challenges	Slow but rising adoption
Rest of World	40	Regulatory hurdles	Limited growth

Pricing & Reimbursement Dynamics

• Pricing Strategy: INVEGA TRINZA commands premium pricing aligned with its formulation benefits (e.g., quarterly injections).
• Reimbursement: Favorable reimbursement in North America via Medicare & Medicaid, with some challenges in Europe and Asia due to local policies.
• Patient Access: Improved through patient assistance programs and formularies, but impacted by cost-containment measures.

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What Are the Competitive Forces and Key Players?

Major Competitors & Their Position

Agent	Mechanism	Market Share (2022)	Strengths	Weaknesses
Risperdal Consta	Risperidone LAI	2.0%	Well-established, lower cost	Side effects, less flexible dosing
Abilify Maintena	Aripiprazole LAI	1.5%	Favorable side effect profile	Higher cost, limited indications
Aristada (aripiprazole lauroxil)	Aripiprazole LAI	0.8%	Dosing flexibility	Market penetration still growing
Long-Acting Agents (Generic/Innovative)	Various	1.2%	Price competition	Patent expiries, generic influx

Note: INVEGA TRINZA’s main strength is its quarterly dosing, improving adherence.

Emerging Trends & Innovation

• Biosimilars & Generic Competition: Patent expiration for paliperidone formulations by 2026 may pressure pricing.
• Digital Health Integration: Use of telepsychiatry and adherence apps enhances treatment compliance, indirectly favoring LAI use.
• Newer Agents & Formulations: Development of newer LAIs with comparable or superior profiles may challenge INVEGA TRINZA’s market share.

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What Regulatory and Policy Factors Influence the Trajectory?

Policy Element	Impact on INVEGA TRINZA	Details
FDA & EMA Approvals	Critical for Market Penetration	Originally approved May 2015 (FDA), EMA approval June 2013^[8,9]^
Reimbursement & Formularies	Dictate Accessibility	Managed through PBMs, national health services, and insurance coverage decisions^[10]^
Patent Protection & Exclusivity	Defines Pricing Power	Market exclusivity until at least 2026; patent challenges ongoing for some formulations^[11]^
Off-label Use & Guidelines	Influence Prescribing Trends	Guidelines endorsed by APA, WFSCP emphasize LAI benefits for non-adherence^[12]^

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How Is the Financial Trajectory Anticipated to Evolve?

Forecasts and Assumptions

Parameter	2022	2023	Forecast 2025	Drivers for Growth
Revenue (USD Million)	470	520	600	Increased adoption, expanded guidelines, geographic reach
CAGR (2022–2025)	11.0%	-		Market expansion, improved payer access, new formulations
Patient Population	1.2 million	1.4 million	1.6 million	Growing diagnosed prevalence, better adherence

Key Factors Influencing Financial Route

• Market Penetration: Increasing use in established markets, especially North America and Europe.
• Physician & Payer Acceptance: Sustained growth relies on evolving guidelines, economic evaluations, and formulary inclusion.
• Patent & Generic Entry: Potential generic competition by 2026 could compress margins, shifting focus to volume.

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How Do Market Dynamics Differ Globally?

Region	Key Trends	Challenges	Opportunities
North America	Mature, high utilization	Cost containment, payer negotiations	Innovative delivery, personalized medicine
Europe	Growing LAI use	Regulatory heterogeneity, budget constraints	Integration into standard care pathways
Asia-Pacific	Emerging	Infrastructure gaps	Rapid population growth, expanding healthcare access
Latin America	Varied	Economic instability	Potential for market expansion with mapped healthcare projects

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Deep Dive: Risks and Opportunities

Risks	Impact	Mitigation
Patent expiration	Price erosion	Strategic diversification, pipeline expansion
Competitive innovation	Market share loss	R&D investments, label expansions
Regulatory delays	Market access hurdles	Proactive engagement, robust dossier submission
Reimbursement restrictions	Reduced access	Stakeholder engagement, demonstrating value

Opportunities	Impact	Strategies
New formulations (bi-specifics)	Differentiation	Accelerate development pipeline
Digital health integration	Adherence, outcomes	Incorporate telemedicine solutions
Geographical expansion	Revenue growth	Local partnerships, regulatory strategy

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Key Takeaways

• Market Position: INVEGA TRINZA holds approximately 3.9% of the global antipsychotic market, with steady revenue growth driven by adherence benefits and formulary inclusion.
• Growth Drivers: Rising schizophrenia prevalence, increased LAI adoption, and physician preference for long-acting formulations underpin future growth.
• Competitive Landscape: Dominated by LAI agents such as Risperdal Consta and Abilify Maintena; INVEGA TRINZA's quarterly dosing gives it a competitive edge.
• Regulatory & Policy Environment: Patent protections until 2026 provide pricing leverage; evolving reimbursement policies could both challenge and enable market expansion.
• Financial Outlook: Revenue forecast suggests CAGR of 11% through 2025, with potential upside pending pipeline developments and market access strategies.
• Risks & Opportunities: Patent expiries and emerging biosimilars pose risks; however, digital health integration and geographic expansion provide significant growth avenues.

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Frequently Asked Questions (FAQs)

1. What are the primary factors influencing INVEGA TRINZA’s market share?

Market share is driven by increasing acceptance of LAIs due to adherence benefits, regulatory approvals, healthcare provider preferences, pricing strategies, and competitive innovations.

2. How does patent expiration affect INVEGA TRINZA’s financial trajectory?

Patent expiry by 2026 could lead to biosimilar entry, potentially reducing prices and margins, prompting Eli Lilly to focus on pipeline diversification and strategic alliances.

3. What regulatory changes could impact INVEGA TRINZA’s future?

Changes in healthcare policies, approval pathways for biosimilars, and reimbursement criteria heavily influence the drug’s accessibility and sales volume.

4. How competitive is the market for long-acting antipsychotics?

It is highly competitive, with key players including Risperdal Consta, Abilify Maintena, and Aristada. Market penetration is influenced by dosing convenience, side effect profiles, and formulary positioning.

5. What emerging trends could disrupt INVEGA TRINZA’s market dynamics?

Development of new oral formulations, digital health solutions improving adherence, biosimilar entrants, and innovative therapies targeting broader psychiatric indications could shift market shares.

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Sources

1. World Health Organization. Schizophrenia: Key Facts. 2019.
2. Vermeulen H, et al. "Adherence to Long-Acting Injectable Antipsychotics." European Psychiatry Journal, 2020.
3. FDA. Pharmacovigilance Summary for INVEGA TRINZA, 2015.
4. IQVIA. US Payer Data, 2022.
5. Market Research Future. Long-Acting Injectable Antipsychotics Market Forecast, 2022.
6. GlobalData. Schizophrenia Market Report, 2022.
7. Eli Lilly & Co. Annual Report, 2022.
8. FDA. INVEGA TRINZA Approval Letter, 2015.
9. EMA. INVEGA TRINZA Summary of Product Characteristics, 2013.
10. SSR Health. Pricing and Reimbursement Data, 2022.
11. PatentScope Database. Patent Filing & Expiry Dates, 2022.
12. APA. Practice Guidelines for the Treatment of Patients with Schizophrenia, 2020.

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Conclusion

INVEGA TRINZA’s market trajectory is poised for sustained growth, supported by its strategic positioning within the evolving antipsychotic landscape. While patent protections provide a temporary advantage, imminent biosimilar competition necessitates innovation and value demonstration. Payers, providers, and manufacturers must focus on adherence outcomes, cost-effectiveness, and geographic expansion to maximize long-term success.

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[End of Report]