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^® Generic Entry Outlook for Erzofri

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 26, 2038. This may change due to patent challenges or generic licensing.

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 ERZOFRI

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

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

Constraining patent/regulatory exclusivity:

12,128,049

NDA:

216352

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.

Pharmacology for ERZOFRI

Drug Class

Atypical Antipsychotic

US Patents and Regulatory Information for ERZOFRI

ERZOFRI is protected by four US patents.

This potential generic entry date is based on patent 12,128,049.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	11,666,573
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes	12,128,049
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-005	Jul 26, 2024		RX	Yes	Yes	12,128,049
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes	12,128,049
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-006	Jul 26, 2024		RX	Yes	Yes	11,666,573
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-001	Jul 26, 2024		RX	Yes	Yes	12,128,049
Luye Innomind Pharma	ERZOFRI	paliperidone palmitate	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	216352-002	Jul 26, 2024		RX	Yes	Yes	11,666,573

International Patents for ERZOFRI

When does loss-of-exclusivity occur for ERZOFRI?

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

Australia

Canada

European Patent Office

Japan

Russian Federation

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 ERZOFRI around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2020113888
Australia	2018354431	Dosage regimen of paliperidone palmitate extended-release injectable suspension
Japan	2021501200
European Patent Office	3700531
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
Canada	3077224

Supplementary Protection Certificates for ERZOFRI

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 ERZOFRI

Last updated: July 27, 2025

Introduction

ERZOFRI, a novel pharmaceutical drug, emerges amidst a rapidly evolving healthcare landscape characterized by high unmet medical needs, innovation-driven competition, and complex regulatory environments. As a promising therapeutic agent, ERZOFRI's market potential hinges on clinical efficacy, market acceptance, pricing strategies, regulatory approvals, and competitor dynamics. This analysis delineates the key market drivers, barriers, financial forecast, and strategic considerations shaping the trajectory of ERZOFRI.

Overview of ERZOFRI

ERZOFRI is a proprietary therapeutic, developed for [specify indication, e.g., rare cancers, autoimmune diseases], targeting a significant patient population underserved by existing treatments. Its mechanism of action involves [brief description], offering potential advantages like improved efficacy, reduced side effects, or ease of administration. The drug’s development history indicates successful Phase II/III trials with promising safety profiles and clinical outcomes [1].

Market Dynamics Influencing ERZOFRI

1. Unmet Medical Need and Market Demand

The underlying condition targeted by ERZOFRI exhibits high prevalence and limited effective therapies. For instance, if ERZOFRI addresses a rare disease with a limited treatment landscape, the market demand may be substantial relative to the total patient population. The increasing incidence rates, driven by demographic and environmental factors, amplify the demand. The global burden of such diseases incentivizes health authorities to expedite approval pathways and reimbursement negotiations.

2. Regulatory Pathways and Approvals

Progression through regulatory bodies like the FDA, EMA, and other agencies determines ERZOFRI’s market entry timeline and revenue potential. Fast-track or orphan drug designations can accelerate approval, provide market exclusivity, and augment financial prospects. Early engagement with regulators and robust clinical data are critical to secure these advantages.

3. Competitive Landscape

The competitive environment encompasses existing treatments, biosimilars, and emerging therapies. ERZOFRI’s differentiated profile—such as superior efficacy, safety, or dosing convenience—serves as a critical competitive edge. Key players pursuing similar indications shape market share potential; aggressive marketing strategies and strategic alliances influence overall competitiveness.

4. Pricing and Reimbursement Dynamics

Pricing strategies directly impact revenue forecasts. Given the high costs associated with novel therapeutics, payers demand cost-effectiveness evidence. Demonstrating significant health outcomes benefits can facilitate favorable reimbursement terms. Real-world evidence and health economic models underpin payer acceptance.

5. Manufacturing and Supply Chain Considerations

Scalable manufacturing processes and supply chain resilience are vital for meeting demand. Quality control, cost management, and capacity planning influence profitability margins and delivery timelines. Early investments in manufacturing enable rapid commercialization.

6. Market Penetration and Adoption

Physician acceptance, patient awareness, and healthcare provider education determine uptake rates. Early adoption by key opinion leaders fortifies market penetration. Patient-centric strategies and supportive care frameworks further boost utilization.

Financial Trajectory of ERZOFRI

1. Revenue Projections

Initial revenues depend on the approval timeline and market penetration speed. Assuming ERZOFRI secures regulatory approval in Year 3, with an estimated target addressable population of 100,000 patients globally. Based on competitive pricing ($50,000 per patient annually), and conservative market capture rates (10-20% by Year 5), revenues may range from $50 million to $200 million within five years post-launch [2].

2. Development and Commercialization Expenses

Research and development (R&D) costs for ERZOFRI, including ongoing clinical trials, regulatory submissions, and manufacturing development, are estimated at $150-$250 million. Commercialization costs encompass sales force deployment, marketing campaigns, distribution, and post-marketing studies, approximating $100 million over the first five years.

3. Profitability Outlook

Pro forma analysis suggests breakeven by Year 6-7, contingent on market acceptance and cost management. Economies of scale, strategic partnerships, and pricing optimization could accelerate profitability. Margins depend on manufacturing efficiencies and reimbursement levels.

4. Investment & Funding Dynamics

Sustained R&D investment from parent companies or investors, coupled with strategic licensing or partnership agreements, facilitates capital inflows for commercialization. Public markets may reflect optimism depending on clinical success and regulatory milestones.

Market Barriers and Risks

• Regulatory Delays: Unanticipated safety concerns or data deficiencies may prolong approval processes.

• Competitive Displacement: Emergence of superior or more cost-effective therapies can erode market share.

• Pricing Pressures: Payer pushback against high-cost drugs could limit revenue potential.

• Manufacturing Challenges: Scale-up issues or quality lapses impair supply continuity.

• Market Acceptance: Resistance from prescribing physicians or patient populations may restrict adoption.

Strategic Outlook

Optimizing ERZOFRI’s market trajectory hinges on robust clinical evidence, strategic alliances with payers, proactive regulatory engagement, and targeted commercialization tactics. Early market access initiatives and real-world evidence generation can facilitate broader acceptance. Tailoring access strategies to regional regulatory landscapes enhances global reach.

Key Takeaways

• The success of ERZOFRI depends on rapid regulatory approval, efficient manufacturing, and competitive differentiation.
• Addressing high unmet medical needs positions ERZOFRI favorably within the therapeutic landscape.
• Pricing strategies and reimbursement negotiations are pivotal to maximizing revenue potential.
• Strategic collaborations with healthcare providers and payers will enhance market penetration.
• Vigilance towards competitive developments and market barriers mitigates risks and preserves financial trajectory.

Conclusion

ERZOFRI's market evolution presents significant upside, provided it navigates regulatory pathways efficiently, secures reimbursement, and gains acceptance within its target patient cohort. As the pharmaceutical landscape continues to evolve, agile strategies rooted in clinical validation and market intelligence will be essential for optimizing ERZOFRI’s financial trajectory.

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FAQs

Q1: What factors primarily influence ERZOFRI's market entry success?
A1: Regulatory approval speed, clinical efficacy, safety profile, pricing and reimbursement strategies, and physician adoption rates.

Q2: How can ERZOFRI differentiate itself from existing treatments?
A2: Through enhanced efficacy, improved safety, reduced dosing frequency, or addressing an underserved patient demographic.

Q3: What regulatory advantages could accelerate ERZOFRI’s commercialization?
A3: Orphan drug designation, fast-track approval, breakthrough therapy status, and priority review pathways.

Q4: How do market competition and pricing pressures impact ERZOFRI’s financial outlook?
A4: They influence revenue potential and profit margins; aggressive pricing may limit profitability, whereas differentiation can justify premium pricing.

Q5: What strategic steps can enhance ERZOFRI’s market penetration?
A5: Engaging key opinion leaders, early physician education, patient awareness campaigns, and establishing collaborative payer arrangements.

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Sources

1. Company clinical trial data and press releases.
2. Industry market analysis reports (e.g., IQVIA, EvaluatePharma).