Paliperidone palmitate - Generic Drug Details

What are the generic sources for paliperidone palmitate and what is the scope of patent protection?

Paliperidone palmitate is the generic ingredient in five branded drugs marketed by Luye Innomind Pharma, Janssen Pharms, and Teva Pharms Usa, and is included in four NDAs. There are seven 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 forty-five patent family members in thirty-three countries.

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

Summary for paliperidone palmitate

International Patents:	145
US Patents:	7
Tradenames:	5
Applicants:	3
NDAs:	4
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	50
Clinical Trials:	58
Patent Applications:	307
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

Recent Clinical Trials for paliperidone palmitate

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Janssen-Cilag International NV	Phase 4
Luye Pharma Group Ltd.	Phase 1

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
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-004	Jul 26, 2024		RX	Yes	Yes
Teva Pharms Usa	PALIPERIDONE PALMITATE	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	211149-004	Jul 6, 2021	AB	RX	No	No
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015		RX	Yes	Yes
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	Jul 31, 2009	AB	RX	Yes	Yes
Janssen Pharms	INVEGA HAFYERA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-006	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	022264-002	Jul 31, 2009
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-001	Jul 31, 2009
Janssen Pharms	INVEGA TRINZA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	207946-002	May 18, 2015
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-002	Jul 31, 2009
Janssen Pharms	INVEGA SUSTENNA	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	022264-004	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
Japan	2011506555
Mexico	2023006366	REGIMENES DE DOSIFICACION ASOCIADOS CON FORMULACIONES INYECTABLES DE PALIPERIDONA DE LIBERACION PROLONGADA. (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS.)
New Zealand	758246	Dosing regimen for missed doses for long-acting injectable paliperidone esters
Portugal	4025188
Eurasian Patent Organization	037185
Slovenia	3744326
European Patent Office	4356966	SCHÉMAS POSOLOGIQUES ASSOCIÉS À DES FORMULATIONS INJECTABLES DE PALIPÉRIDONE À LIBÉRATION PROLONGÉE (DOSING REGIMENS ASSOCIATED WITH EXTENDED RELEASE PALIPERIDONE INJECTABLE FORMULATIONS)

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	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
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	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

Market Dynamics and Financial Trajectory for Paliperidone Palmitate

Introduction

Paliperidone palmitate, a long-acting injectable atypical antipsychotic, has been gaining significant traction in the pharmaceutical market due to its efficacy in treating schizophrenia and other psychiatric disorders. This article delves into the market dynamics and financial trajectory of paliperidone palmitate, highlighting key trends, drivers, and challenges.

Market Growth and Projections

The paliperidone palmitate API market has experienced rapid and substantial growth in recent years. Projections indicate a continued significant expansion from 2023 to 2031, driven by the upward trend in market dynamics and sustained growth rates[1].

Segmentation and Market Size

The market is segmented based on type (min purity less than 98%, min purity 98%-99%, min purity more than 99%) and application (research, pharmaceutical). Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. The report provides detailed market size and predictions in USD million across these segments[1].

Drivers of Market Growth

Several factors are driving the growth of the paliperidone palmitate market:

Improved Medication Adherence

Long-acting injectable (LAI) formulations of paliperidone palmitate significantly improve medication adherence among patients with schizophrenia, reducing recurrence and rehospitalization rates without compromising clinical efficacy[3].

Clinical Efficacy

Paliperidone palmitate has demonstrated superior performance in reducing recurrence rates, treating negative symptoms, and improving patients’ quality of life compared to first-generation antipsychotics[3].

Economic Benefits

Cost-utility analyses indicate that paliperidone palmitate formulations are more cost-effective than oral extended-release (ER) formulations, especially when considering the long-term benefits and reduced hospitalization costs[3][4].

Financial Performance of Key Players

Companies like Johnson & Johnson, which markets paliperidone palmitate under brands such as INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA, have seen significant sales growth. For instance, Johnson & Johnson reported a 13.8% increase in pharmaceutical sales in 2021, partly driven by the performance of these products[2].

Competitive Scenario

The market is competitive, with several key players including Tecoland, Jigs Chemical, VEEPRHO, Bal Pharma, Venkatasai Life Sciences, MuseChem, Pharmaffiliates, Wuhan Fortuna Chemical, and CHEMVON BIOTECHNOLOGY (SHANGHAI). These companies are profiled in market reports, providing insights into their market entry, product offerings, and other relevant factors[1].

Market Outlook and Trends

Porter's 5 Forces Framework

The market outlook includes an extensive exploration of Porter's 5 Forces Framework, which helps in understanding the competitive intensity and attractiveness of the market. This framework considers factors such as the threat of new entrants, the threat of substitute products, the bargaining power of buyers and suppliers, and the intensity of competitive rivalry[1].

Macroeconomic Scrutiny

Macroeconomic factors, including national GDP, dynamics within the overarching market and its submarkets, and the economic, political, and social landscapes of countries, are crucial in shaping the market trajectory. These factors influence product pricing, market penetration, and consumer behavior[1].

Value Chain Analysis

A detailed value chain analysis provides insights into the various stages of the product lifecycle, from raw material sourcing to end-user delivery. This analysis helps in identifying cost-saving opportunities and optimizing the supply chain[1].

Cost-Utility Analysis

Studies have shown that paliperidone palmitate formulations are cost-effective compared to oral extended-release formulations. For example, a cost-utility analysis in China revealed that after 20 years, the use of paliperidone palmitate 1-month formulation (PP1M) and 3-month formulation (PP3M) resulted in increased quality-adjusted life years (QALYs) at a lower incremental cost-effectiveness ratio (ICER) than ER[3].

Regional Market Dynamics

Asia-Pacific

In countries like China, despite the advantages of LAIs, their usage remains relatively low due to high costs. However, with paliperidone palmitate included in the national medical insurance system, prescription rates are expected to increase gradually[3].

Developed Markets

In developed countries, the prescription rate for antipsychotic LAIs is significantly higher, ranging from 18% to 30%. This difference in usage highlights the potential for growth in emerging markets[3].

Challenges and Opportunities

High Costs

One of the primary challenges is the high cost of paliperidone palmitate, which can be a barrier to adoption, especially in regions with limited healthcare budgets[3].

Generic Entry

The entry of generic versions of paliperidone palmitate could reduce costs and increase accessibility. Simulations suggest that price reductions due to generic entry could make these formulations more cost-effective[3].

Regulatory Environment

Changes in regulatory policies and reimbursement rates can significantly impact the market. For instance, the inclusion of paliperidone palmitate in national medical insurance systems can boost prescription rates[3].

Future Prospects

The future of the paliperidone palmitate market looks promising, driven by increasing demand for effective and adherence-friendly treatments for schizophrenia. As more countries include these formulations in their healthcare systems, the market is expected to expand further.

Key Takeaways

• The paliperidone palmitate API market is projected to experience significant growth from 2023 to 2031.
• Improved medication adherence and clinical efficacy are key drivers of market growth.
• Cost-utility analyses indicate that paliperidone palmitate formulations are more cost-effective than oral ER formulations.
• Regional dynamics, including regulatory changes and generic entry, will play a crucial role in shaping the market.
• High costs remain a challenge, but inclusion in medical insurance systems can mitigate this issue.

FAQs

What are the primary drivers of the paliperidone palmitate market growth?

The primary drivers include improved medication adherence, superior clinical efficacy, and cost-effectiveness compared to oral extended-release formulations.

Which regions have the highest prescription rates for antipsychotic LAIs?

Developed countries have the highest prescription rates, ranging from 18% to 30%, while emerging markets like China have lower rates due to high costs.

How does the inclusion of paliperidone palmitate in national medical insurance systems impact the market?

Inclusion in national medical insurance systems can significantly increase prescription rates by reducing the financial burden on patients and making the treatment more accessible.

What is the impact of generic entry on the paliperidone palmitate market?

Generic entry is expected to reduce costs, making the treatment more affordable and increasing its accessibility, thereby boosting market growth.

What are the key challenges facing the paliperidone palmitate market?

High costs and limited adoption in some regions due to financial constraints are significant challenges, although these can be mitigated by regulatory changes and generic entry.

Sources

1. Market Research Intellect, "Paliperidone Palmitate API Market Size, Scope And Forecast Report," November 2024.
2. Johnson & Johnson, "FOR IMMEDIATE RELEASE • Total sales growth of 10.7% to $23.3 billion," October 19, 2021.
3. Frontiers in Pharmacology, "Cost-utility analysis of using paliperidone palmitate in schizophrenia in China," August 3, 2023.
4. Analysis Group, "Projecting the Economic Outcomes of Switching Patients with Schizophrenia from Oral Atypical Antipsychotics to Once-Monthly, Once-Every-3-Months, and Once-Every-6-Months Paliperidone Palmitate."