Paliperidone palmitate - Generic Drug Details

What are the generic drug sources for paliperidone palmitate and what is the scope of freedom to operate?

Paliperidone palmitate is the generic ingredient in four branded drugs marketed by Luye Innomind Pharma and Janssen Pharms, and is included in three NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Paliperidone palmitate has one hundred and seventy-seven patent family members in thirty-six countries.

There are twelve drug master file entries for paliperidone palmitate. Three suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for paliperidone palmitate

International Patents:	177
US Patents:	8
Tradenames:	4
Applicants:	2
NDAs:	3
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	59
Patent Applications:	687
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for paliperidone palmitate
What excipients (inactive ingredients) are in paliperidone palmitate?	paliperidone palmitate excipients list
DailyMed Link:	paliperidone palmitate at DailyMed

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

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

Dosage:

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*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 paliperidone palmitate

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

Sponsor	Phase
Jiangsu Province Nanjing Brain Hospital	PHASE4
First Affiliated Hospital Xi'an Jiaotong University	N/A
Janssen-Cilag International NV	Phase 4

See all paliperidone palmitate clinical trials

Generic filers with tentative approvals for PALIPERIDONE PALMITATE

Applicant	Application No.	Strength	Dosage Form
			SUSPENSION;EXTENDED RELEASE
		234MG/1.5ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
		156MG/ML	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for paliperidone palmitate

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for paliperidone palmitate

Antipsychotic Agents

Dopamine D2 Receptor Antagonists

Serotonin 5-HT2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for paliperidone palmitate

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for PALIPERIDONE PALMITATE

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
INVEGA SUSTENNA	Extended-release Injectable Suspension	paliperidone palmitate	39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL and 234 mg/1.5 mL	022264	1	2017-11-21

US Patents and Regulatory Information for paliperidone palmitate

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 SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009		RX	Yes	No
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	Aug 30, 2021		RX	Yes	No
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-003	May 18, 2015		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-005	Aug 30, 2021		RX	Yes	No
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-001	Jul 26, 2024		RX	Yes	Yes

Expired US Patents for paliperidone palmitate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-003	Jul 31, 2009
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-004	May 18, 2015
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-005	Jul 31, 2009

International Patents for paliperidone palmitate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3744326	SCHÉMA DE TRAITEMENT EN CAS DE DOSES OUBLIÉES POUR DES ESTERS DE PALIPÉRIDONE INJECTABLES À ACTION PROLONGÉE (DOSING REGIMEN FOR MISSED DOSES FOR LONG-ACTING INJECTABLE PALIPERIDONE ESTERS)
Australia	2018354431
Brazil	PI0821408	Regime de dosagem associado a ésteres de paliperidona injetáveis de longa ação
Russian Federation	2020113888	СПОСОБ ВВЕДЕНИЯ СУСПЕНЗИИ ПАЛИПЕРИДОНА ПАЛЬМИТАТА ДЛЯ ИНЪЕКЦИЙ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ
Portugal	4005555
Poland	4025187

Supplementary Protection Certificates for paliperidone palmitate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION NO/DATE: EU/1/11/672/001-006 20110304
0904081	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304
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	SPC/GB11/044	United Kingdom		PRODUCT NAME: PALIPERIDONE PALMITATE; REGISTERED: UK EU/1/11/672/001 20110304; UK EU/1/11/672/002 20110304; UK EU/1/11/672/003 20110304; UK EU/1/11/672/004 20110304; UK EU/1/11/672/005 20110304; UK EU/1/11/672/006 20110304

Market Dynamics and Financial Trajectory for Paliperidone Palmitate

Last updated: July 27, 2025

Introduction

Paliperidone palmitate, marketed under prominent trade names such as Invega Sustenna and Invega Trinza, has established itself as a cornerstone in the management of schizophrenia and bipolar disorder. As a long-acting injectable (LAI) formulation of paliperidone—an active metabolite of risperidone—this drug is favored for its extended-release profile, improved adherence, and consistent plasma levels. The emerging market landscape, driven by evolving psychiatric treatment paradigms, regulatory adaptations, and demographic shifts, significantly influences the financial trajectory of paliperidone palmitate.

Market Overview and Demand Drivers

Growing Prevalence of Schizophrenia and Bipolar Disorder

The global burden of schizophrenia affects approximately 20 million people, with bipolar disorder impacting around 45 million worldwide[^1]. Increasing awareness, improved diagnostic techniques, and destigmatization initiatives have expanded treatment rates, fueling demand for pharmacological interventions like paliperidone palmitate.

Preference for Long-Acting Injectables

The shift towards LAIs, including paliperidone palmitate, is driven by their proven efficacy in improving medication adherence, reducing relapse rates, and lowering hospitalization costs[^2]. Healthcare providers increasingly favor LAIs for chronic psychiatric conditions, which correlates with sustained or rising demand.

Regulatory Approvals and Indications Expansion

Paliperidone palmitate received FDA approval in 2009 for schizophrenia maintenance therapy, followed by approvals in other jurisdictions for various durations and indications[^3]. Recent data suggest an extension into bipolar disorder maintenance, broadening the drug's market potential.

Technological and Formulation Advancements

Enhanced formulations, including the longer-acting Invega Trinza (three-monthly injections), have improved patient compliance and convenience. These innovations often command premium pricing, positively impacting revenue streams.

Competitive Landscape

Key Players and Market Share

Eli Lilly and Johnson & Johnson (via Janssen Pharmaceuticals) dominate the paliperidone palmitate market. The competitive landscape faces pressure from other LAI antipsychotics like risperidone microspheres, olanzapine pamoate, and newer oral agents. Market share shifts are influenced by factors such as efficacy, tolerability, and formulary inclusion.

Biosimilar and Patent Challenges

While biosimilar development in antipsychotics is emerging, patent protections for key formulations—such as Invega Trinza—offer exclusivity periods, delaying biosimilar penetration and maintaining high-profit margins[^4].

Market Dynamics Influencing Financial Trajectory

Pricing Strategies and Reimbursement Policies

Premium pricing for long-acting formulations fuels revenue. However, reimbursement policies and formulary restrictions exert downward pressure, especially in cost-conscious healthcare systems like in Europe and North America. Negotiations with insurance providers and healthcare programs significantly influence sales volume.

Market Penetration in Emerging Economies

While penetration in developed markets is mature, emerging economies present growth opportunities due to increasing mental health awareness and expanding psychiatric services. Price adjustments and local manufacturing partnerships are pivotal for sustainable growth.

Regulatory and Policy Environment

Stringent regulatory standards and evolving guidelines for mental health treatments impact market access. Future approvals for broad indications could unlock incremental revenue, but delays can also constrict growth.

Patent Expirations and Intellectual Property

Patents typically expire 8-10 years post-launch, leading to generics and biosimilars entering the market. Strategic lifecycle management, such as formulation innovations and patent extensions, remain critical for revenue protection.

Financial Trajectory Analysis

Revenue Trends and Forecasts

Current data indicate steady revenue growth driven by increased adoption and approval of longer-acting formulations[^5]. The global schizophrenia market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of approximately 3-5% over the next five years, with paliperidone palmitate capturing a significant share due to its clinical profile.

Impact of Patent Expiry and Biosimilars

The upcoming patent expirations—expected around 2026 for Invega Trinza—could lead to revenue declines unless offset by biosimilar competition or new formulations. Companies adopting aggressive lifecycle strategies may buffer these impacts.

Cost and Investment Considerations

Research and development expenditures are high for novel formulations and indication expansions. Clinical trial investments for extended indications or combination therapies directly influence profit margins and future growth potential.

Emerging Markets and Strategic Alliances

Partnerships with local distributors and governments facilitate market entry into low- and middle-income countries. These alliances are crucial for volume-driven growth and balancing revenue streams against pricing pressures.

Future Outlook and Strategic Implications

The trajectory for paliperidone palmitate is sustained but cautious, shaped by patent protection, competitive innovations, reimbursement dynamics, and geographic expansion. Strategic emphasis on formulation improvements, new therapeutic indications, and global access initiatives can bolster revenue resilience.

Key Challenges and Opportunities

• Challenges:
  • Patent cliffs and biosimilar entry.
  • Pricing pressures owing to healthcare cost containment.
  • Regulatory hurdles in emerging markets.
• Opportunities:
  • Expansion into bipolar disorder maintenance.
  • Adoption of longer-acting formulations.
  • Collaborations in untapped markets.

Conclusion

Paliperidone palmitate's market dynamics are marked by steady growth underpinned by therapeutic advantages, regulatory support, and innovation. Its financial trajectory remains favorable in the medium term, contingent on strategic lifecycle management, market access, and continued demand for long-acting antipsychotics. Stakeholders must navigate patent expirations and geopolitical considerations while capitalizing on emerging opportunities to sustain financial performance.

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Key Takeaways

• Growing Demand: Increasing prevalence of schizophrenia and bipolar disorder propels demand for long-acting injectable antipsychotics like paliperidone palmitate.
• Market Expansion: Regulatory approvals and formulations innovations, notably three-monthly injections, expand market potential and revenue streams.
• Competitive Pressures: Patent protections delay biosimilar entry, maintaining high margins, but eventual patent cliffs pose risks.
• Pricing and Reimbursement: Pricing strategies and healthcare policies significantly influence sales volume and profitability.
• Emerging Markets: Untapped economies offer growth avenues, provided manufacturers adapt pricing and localization strategies.

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FAQs

1. How does paliperidone palmitate compare to oral antipsychotics in terms of market performance?
Paliperidone palmitate offers improved adherence, reduced relapse, and lower hospitalization rates versus oral formulations. While often priced higher, its clinical benefits justify premium positioning, especially in markets prioritizing outpatient management and cost savings from avoided hospitalizations.

2. What impact will patent expiration have on paliperidone palmitate's revenue?
Patent expirations, expected around 2026, will likely introduce biosimilars reducing prices and market share. Companies will need to deploy lifecycle extension strategies and diversify indications to mitigate revenue loss.

3. Are there upcoming regulatory changes that could affect paliperidone palmitate?
Regulatory agencies continue to refine guidelines for biosimilar approval, reimbursement, and post-marketing surveillance, potentially affecting market access. Additionally, approval for new indications could enhance profitability.

4. How do reimbursement policies influence the adoption of paliperidone palmitate?
Reimbursement policies that favor LAIs, through favorable formulary placement or reduced hospitalizations, incentivize prescribing. Conversely, cost containment measures can hinder growth, especially in publicly funded healthcare systems.

5. What are the prospects for growth in emerging markets?
Emerging markets present significant growth potential due to rising mental health awareness, expanding healthcare infrastructure, and increasing acceptance of LAIs. Local partnerships and adjusted pricing models are key success factors.

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References

[^1]: World Health Organization. “Mental health: strengthening our response.” 2021.
[^2]: Citrome L. “The role of long-acting injectable antipsychotics in schizophrenia.” Dialogues in Clinical Neuroscience. 2019.
[^3]: FDA. “Invega Sustenna FDA Approval.” 2009.
[^4]: MarketLine. “Pharmaceuticals Industry Profile.” 2022.
[^5]: IQVIA. “Global Medicine Spending and Usage Trends.” 2022.