INVEGA TRINZA Drug Patent Profile

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

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	10,143,693
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015		RX	Yes	Yes	10,143,693
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes	10,143,693
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes	10,143,693

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	207946-003	May 18, 2015	6,077,843*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-001	May 18, 2015	6,077,843*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015	6,077,843*PED
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015	6,077,843*PED

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
Hungary	E065573
Estonia	9800136
Poland	327995
Japan	2018510894	長時間作用型注射可能パリペリドンエステルの抜かした投与量のための投与レジメン
European Patent Office	4385564
Denmark	0904081

Supplementary Protection Certificates for INVEGA TRINZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904081	91842	Luxembourg		91842, EXPIRES: 20220512
0904081	1190023-0	Sweden		PRODUCT NAME: PALIPERIDONPALMITAT; REG. NO/DATE: EU/1/11/672/001-006 20110304
0368388	07C0044	France		PRODUCT NAME: PALIPERIDONE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/395/01 DU 20070626; REGISTRATION NO/DATE AT EEC: EU/1/07/395/01 DU 20070625
0904081	C00904081/01	Switzerland		PRODUCT NAME: PALIPERIDON PALMITATESTER; REGISTRATION NO/DATE: SWISSMEDIC 60466 20101215
0904081	416	Finland
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304

Market Dynamics and Financial Trajectory for INVEGA TRINZA

Last updated: July 27, 2025

Introduction

INVEGA TRINZA (paliperidone palmitate extended-release injectable suspension) is a long-acting atypical antipsychotic primarily indicated for schizophrenia maintenance. Introduced by Janssen Pharmaceuticals in 2015, INVEGA TRINZA has established a significant footprint within the mental health segment, leveraging its extended dosing interval and efficacy. This analysis explores the evolving market dynamics and financial trajectory of INVEGA TRINZA amid competitive pressures, regulatory influences, and healthcare trends.

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Market Landscape and Key Drivers

Growing Demand for Long-Acting Injectables

The global schizophrenia market exhibits rising demand for long-acting injectable antipsychotics (LAIAs), driven by their improved adherence profiles and reduced relapse rates. According to Grand View Research, the LAIA segment is projected to grow at a compound annual growth rate (CAGR) of approximately 7.3% from 2021 to 2028[1]. INVEGA TRINZA’s once-every-two-month dosing schedule presents a competitive edge, appealing to clinicians seeking methods to enhance compliance and reduce hospitalization costs.

Shifting Prescribing Patterns and Patient Preferences

Clinician preferences are increasingly favoring LAIAs over oral formulations, especially for patients with adherence challenges and high relapse risk. The convenience of less frequent injections (eight-week interval) positions INVEGA TRINZA favorably compared to competitors like Risperdal Consta or Abilify Maintena, which typically require biweekly or monthly administration. Patient acceptance is further bolstered by the reduced side-effects profile and favorable safety data, fostering sustained demand.

Competitive and Product Landscape

The antipsychotic market features notable competitors, including:

• Risperdal Consta (risperidone): marketed for similar indications, with a longer track record.
• Invega Sustenna (paliperidone palmitate monthly): provides an alternative dosing schedule.
• Aripiprazole Launda (once-monthly): offers a different mechanism for maintenance therapy.

However, INVEGA TRINZA’s unique extended dosing interval affords a distinct advantage, enabling healthcare providers to streamline treatment schedules, reduce clinic visits, and improve patient quality of life.

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Regulatory and Reimbursement Environment

Regulatory Approvals and Market Access

INVEGA TRINZA’s approval across major markets (U.S., EU, Japan) has facilitated broad access. Post-approval, continued efforts to expand indications and promote awareness influence prescribing patterns. Regulatory support often hinges on real-world outcomes demonstrating efficacy and safety, which Janssen actively promotes through post-marketing studies.

Reimbursement Trends

Reimbursement frameworks increasingly favor LAIAs given their potential to lower hospitalization costs and improve adherence. In the U.S., Medicare and Medicaid reimbursement policies have progressively aligned with this trend, supporting sustained sales growth. However, high per-injection costs (~$2,000–$3,000 depending on dosage) can limit access in certain regions, emphasizing the importance of formulary negotiations and patient assistance programs.

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Financial Trajectory and Revenue Projections

Historical Performance

Since its launch, INVEGA TRINZA has experienced steady revenue increases, consistent with growing acceptance of LAIAs. In 2021, Janssen reported annual revenues exceeding $300 million from INVEGA TRINZA, reflecting a compound annual growth rate (CAGR) of approximately 10-12% since launch[2]. The product’s success derives from its ease of administration, efficacy, and differentiated dosing frequency.

Future Revenue Outlook

Favorable market conditions and expanding indications—such as potential use in bipolar disorder—may expedite growth. Analysts project a CAGR of around 9% through 2027, reaching revenues in excess of $500 million globally[3]. The trajectory depends heavily on:

• Market penetration strategies: Educating clinicians and expanding formulary access.
• Pricing strategies: Balancing reimbursement pressures with commercial sustainability.
• Competitive dynamics: Launch of biosimilars or new therapeutics could temper growth.

Risk Factors

Key risks include reimbursement challenges, market saturation, and emerging competitors. Additionally, the patent landscape and potential biosimilar developments could impact pricing power and revenue streams.

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Market Challenges and Opportunities

Challenges

• Pricing Pressures: Payers' push for value-based care may constrain pricing flexibility.
• Generic and Biosimilar Competition: While not currently facing biosimilar competition, upcoming patent expirations could introduce generic equivalents.
• Adherence Complexity: Despite extended intervals, some patients may prefer oral therapy or shorter-acting injectables due to personal preference or side-effect profiles.

Opportunities

• Expanding Indications: Broader use in bipolar disorder and other psychotic conditions can diversify revenue streams.
• Geographic Expansion: Emerging markets present untapped potential, contingent on regulatory approvals and healthcare infrastructure.
• Digital and Patient Support Initiatives: Improved patient engagement strategies can enhance adherence and market share.

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Conclusion

INVEGA TRINZA’s market dynamics are positively aligned with the global shift toward long-acting injectable antipsychotics. Its extended dosing interval offers a clear competitive advantage that supports sustained financial growth. While challenges such as reimbursement pressures and competitive threats persist, strategic positioning through clinical evidence dissemination, geographic expansion, and indication diversification will likely propel its financial trajectory upward over the coming years.

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Key Takeaways

• INVEGA TRINZA benefits from the growing acceptance of LAIAs driven by adherence, efficacy, and convenience.
• The product’s unique dosing regimen positions it favorably against competitors, fueling steady revenue growth.
• Reimbursement policies in developed markets increasingly favor LAIAs, supporting market penetration.
• Potential patent expiries and biosimilar entries pose risks but can be mitigated through innovation and indication expansion.
• Strategic focus on expanding indications and geographies will be crucial to maintaining its market momentum and revenue streams.

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FAQs

1. What factors differentiate INVEGA TRINZA from other long-acting injectables?
Its twice-yearly dosing schedule offers unmatched convenience, reducing clinic visits and improving adherence compared to competitors requiring monthly or biweekly injections.

2. How does market acceptance of INVEGA TRINZA influence its financial outlook?
Growing clinician preference for LAIAs and positive patient outcomes support expanding demand, thereby strengthening its revenue trajectory.

3. What are the main risks to INVEGA TRINZA’s future earnings?
Patent cliffs, biosimilar entry, reimbursement hurdles, and increased competition could temper revenue growth.

4. How significant is the potential for expanding INVEGA TRINZA’s indications?
High—potential use in bipolar disorder and other psychotic conditions could diversify revenue sources significantly.

5. What role do reimbursement policies play in INVEGA TRINZA’s market performance?
Reimbursement policies that favor LAIAs enhance access and sales, whereas restrictions or high out-of-pocket costs can limit growth.

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References

1. Grand View Research. Long-acting injectables market analysis, 2021–2028.
2. Janssen Pharmaceuticals. Annual financial reports, 2021–2022.
3. MarketWatch. Pharmaceutical market forecasts, 2023.