ERZOFRI Drug Patent Profile

Which patents cover Erzofri, and when can generic versions of Erzofri launch?

Erzofri is a drug marketed by Luye Innomind Pharma and is included in one NDA. There are two patents protecting this drug.

This drug has seven patent family members in six countries.

The generic ingredient in ERZOFRI 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^® Litigation and Generic Entry Outlook for Erzofri

A generic version of ERZOFRI was approved as paliperidone palmitate by TEVA PHARMS USA on July 6^th, 2021.

Summary for ERZOFRI

International Patents:	7
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	ERZOFRI at DailyMed

Pharmacology for ERZOFRI

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ERZOFRI

ERZOFRI is protected by four US patents.

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	216352-001	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes

International Patents for ERZOFRI

See the table below for patents covering ERZOFRI around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3700531	SCHÉMA POSOLOGIQUE D'UNE SUSPENSION INJECTABLE À LIBÉRATION PROLONGÉE DE PALMITATE DE PALIPÉRIDONE (DOSAGE REGIMEN OF PALIPERIDONE PALMITATE EXTENDED-RELEASE INJECTABLE SUSPENSION)
Japan	2021501200	パリペリドンパルミチン酸エステル徐放性懸濁注射液の投薬レジメン
Australia	2018354431	Dosage regimen of paliperidone palmitate extended-release injectable suspension
Russian Federation	2020113888	СПОСОБ ВВЕДЕНИЯ СУСПЕНЗИИ ПАЛИПЕРИДОНА ПАЛЬМИТАТА ДЛЯ ИНЪЕКЦИЙ С ПРОЛОНГИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ

Supplementary Protection Certificates for ERZOFRI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0904081	2011/021	Ireland		PRODUCT NAME: PALIPERIDONE PALMITATE ESTER; REGISTRATION 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	11C0035	France		PRODUCT NAME: PALMITATE DE PALIPERIDONE; REGISTRATION NO/DATE: EU/1/11/672/001 20110304

ERZOFRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ERZOFRI

Introduction

ERZOFRI, developed by Luye Pharma Group, is a significant addition to the treatment landscape of schizophrenia and schizoaffective disorder. This extended-release injectable solution of paliperidone palmitate has garnered considerable attention due to its potential to improve patient adherence and outcomes. Here, we delve into the market dynamics and financial trajectory of ERZOFRI.

FDA Approval and Market Significance

ERZOFRI received FDA approval in August 2024, marking a crucial milestone for Luye Pharma and the psychiatric treatment sector. This approval is under the 505(b)(2) procedure, which allows for a faster and more streamlined approval process for drugs that are similar to existing approved drugs but offer some improvements or differences[1].

Impact on Patient Adherence

One of the key benefits of ERZOFRI is its extended-release mechanism, which requires a monthly dosing regimen. This is particularly important for schizophrenia and schizoaffective disorder, where poor adherence to medication is a significant issue. By reducing the frequency of dosing, ERZOFRI aims to enhance patient compliance and potentially improve long-term treatment outcomes[1].

Market Competition and Growth

The schizophrenia drugs market is projected to grow significantly, with the global market size expected to increase from USD 7.90 billion in 2023 to USD 11.94 billion by 2031, at a CAGR of 5.3%[4]. ERZOFRI, being the first Chinese-developed paliperidone palmitate LAI (Long-Acting Injectable) to receive US approval, positions Luye Pharma competitively in this market.

Financial Performance of Luye Pharma

Luye Pharma's financial performance has been robust, with total revenue increasing by 6% year-over-year to RMB 3.07 billion in the first half of 2024. The gross profit rose by 7% to RMB 2.08 billion, and the net profit surged by 201% to RMB 438 million. This significant growth is partly attributed to the launch of new products, including ERZOFRI, which is expected to contribute substantially to the company's revenue in the coming years[2].

Patent Protection and Competitive Advantage

ERZOFRI has been granted a US patent (Patent No. 11,666,573) that provides protection until 2039. This extended patent life gives Luye Pharma a competitive advantage, allowing the company to maintain market presence and potentially increase sales without immediate generic competition[1].

Revenue Projections

The approval of ERZOFRI is expected to boost Luye Pharma's revenue, particularly in the CNS (Central Nervous System) segment. The revenue from CNS products already saw a 21% year-over-year increase to RMB 823 million in the first half of 2024. With ERZOFRI's introduction, this segment is anticipated to grow further, contributing to the company's overall financial growth[2].

Market Dynamics in the Schizophrenia Drugs Market

The schizophrenia drugs market is driven by several factors, including the rising incidence of schizophrenia, increasing awareness of mental health, and growing investments in R&D for novel treatments. However, challenges such as high treatment costs and limited efficacy of existing drugs also impact market dynamics. ERZOFRI's entry into this market addresses some of these challenges by offering a more adherent-friendly treatment option[4].

Distribution and Accessibility

The demand for schizophrenia drugs, particularly injectable solutions like ERZOFRI, is expected to rise in retail pharmacies due to the availability of personalized services such as patient counseling and medication management. This trend is likely to benefit ERZOFRI's market penetration and sales[4].

Regional Market Dominance

North America, particularly the United States and Canada, is expected to be a leading market for schizophrenia drugs, including ERZOFRI. High awareness of mental health, significant investments in R&D, and the presence of key drug providers in this region will drive the demand for ERZOFRI[4].

Expert Insights and Future Outlook

Rongbing Yang, President of Luye Pharma Group, highlighted the company's confidence in its new products, including ERZOFRI, stating that these medications will drive "explosive growth" in the coming years. The company's strategic focus on R&D, sales and marketing, and financial optimization is expected to further enhance its market position and financial performance[2].

"ERZOFRI's approval demonstrates the changing landscape of psychiatric treatment, providing optimism for increased patient adherence and better management of schizophrenia and schizoaffective disorders." - Source: FDA Approval Announcement[1]

Key Takeaways

• FDA Approval: ERZOFRI received FDA approval in August 2024 for treating schizophrenia and schizoaffective disorder.
• Market Significance: It is the first Chinese-developed paliperidone palmitate LAI to receive US approval.
• Patient Adherence: The extended-release mechanism improves patient compliance.
• Financial Performance: Luye Pharma's revenue and net profit have seen significant growth, partly due to new product launches.
• Patent Protection: ERZOFRI has a US patent until 2039, providing a competitive advantage.
• Market Dynamics: The schizophrenia drugs market is growing, driven by increasing awareness and investments in R&D.
• Regional Dominance: North America is expected to be a leading market for ERZOFRI.

FAQs

What is ERZOFRI, and how does it differ from other antipsychotic medications?

ERZOFRI is an extended-release injectable solution of paliperidone palmitate, approved for treating schizophrenia and schizoaffective disorder. It differs from daily oral drugs by requiring only a monthly dosing regimen, which improves patient adherence.

How significant is the FDA approval of ERZOFRI for Luye Pharma?

The FDA approval of ERZOFRI is a key milestone for Luye Pharma, marking the company's entry into the US market with a novel therapeutic option and expanding its global presence.

What are the financial implications of ERZOFRI's approval for Luye Pharma?

ERZOFRI's approval is expected to contribute significantly to Luye Pharma's revenue growth, particularly in the CNS segment, and has already been reflected in the company's robust financial performance in 2024.

How does ERZOFRI address the issue of patient adherence in schizophrenia treatment?

ERZOFRI's extended-release mechanism reduces the frequency of dosing to once a month, which is critical for improving patient compliance and potentially enhancing long-term treatment outcomes.

What is the projected market size for schizophrenia drugs, and how will ERZOFRI fit into this market?

The global schizophrenia drugs market is projected to grow from USD 7.90 billion in 2023 to USD 11.94 billion by 2031. ERZOFRI, with its unique extended-release formulation, is expected to capture a significant share of this growing market.

How does the patent protection for ERZOFRI impact its market position?

The US patent granted to ERZOFRI until 2039 provides Luye Pharma with a competitive advantage, allowing the company to maintain market presence and potentially increase sales without immediate generic competition.

Sources

1. FDA Approves Luye Pharma's Erzofri for Schizophrenia & Schizoaffective Disorder - Drug Today Online
2. Luye Pharma Announces 2024 Half Year Results - Luye Pharma
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Schizophrenia Drugs Market Size, Share, Growth Analysis - SkyQuestT
5. Gene Lee: Latest news and mentions - MarketScreener