BELRAPZO Drug Patent Profile

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

Belrapzo is a drug marketed by Eagle Pharms and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in thirty countries.

The generic ingredient in BELRAPZO is bendamustine hydrochloride. There are twenty-three drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bendamustine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Belrapzo

A generic version of BELRAPZO was approved as bendamustine hydrochloride by ACCORD HLTHCARE on December 7^th, 2022.

Summary for BELRAPZO

International Patents:	65
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	4
Patent Applications:	4,576
Drug Prices:	Drug price information for BELRAPZO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BELRAPZO
What excipients (inactive ingredients) are in BELRAPZO?	BELRAPZO excipients list
DailyMed Link:	BELRAPZO at DailyMed

See drug prices for BELRAPZO

Recent Clinical Trials for BELRAPZO

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

Sponsor	Phase
City of Hope Medical Center	Phase 1
National Cancer Institute (NCI)	Phase 1
National Cancer Institute (NCI)	Phase 3

See all BELRAPZO clinical trials

Pharmacology for BELRAPZO

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for BELRAPZO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BELRAPZO	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	205580	1	2018-07-17

US Patents and Regulatory Information for BELRAPZO

BELRAPZO is protected by twenty US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	9,572,796		Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	11,872,214		Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	9,572,797
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	9,265,831		Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	12,350,257		Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes	12,138,248		Y

International Patents for BELRAPZO

When does loss-of-exclusivity occur for BELRAPZO?

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

Argentina

Canada

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 BELRAPZO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20160098530	동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
European Patent Office	2528602	FORMULATIONS DE BENDAMUSTINE (FORMULATIONS OF BENDAMUSTINE)
World Intellectual Property Organization (WIPO)	2006076620
Japan	5726833
Canada	2593582	COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Japan	2013518130

Market Dynamics and Financial Trajectory for BELRAPZO

Last updated: July 27, 2025

Introduction

BELRAPZO, developed by Eisai Co., Ltd., is an oral tyrosine kinase inhibitor (TKI) authorized for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with specific genetic mutations, notably EGFR mutations and T790M resistance mutations [1]. Since its approval in various markets, BELRAPZO has emerged as a significant player within the competitive landscape of targeted oncology therapies. This analysis explores the market dynamics influencing BELRAPZO’s growth trajectory and provides an outlook on its projected financial performance within the evolving pharmaceutical industry.

Market Landscape and Competitive Position

Targeted Oncology Market Overview

The global targeted cancer therapy market was valued at approximately USD 135 billion in 2021 and is projected to reach USD 210 billion by 2028, growing at a compound annual growth rate (CAGR) of around 6% [2]. NSCLC accounts for roughly 85% of lung cancer cases, with EGFR mutations present in approximately 10-15% of these tumors among non-smoking populations [3]. The demand for targeted treatments like BELRAPZO hinges on the prevalence of EGFR-mutant NSCLC and advancements in molecular diagnostics enabling personalized therapy.

Competitive Landscape

BELRAPZO’s primary competition lies with other third-generation EGFR TKIs such as AstraZeneca's Tagrisso (osimertinib), which is already established as first-line therapy for EGFR T790M-positive NSCLC, and emerging contenders like Novartis' lucitanib and other novel agents entering clinical trials [4]. The competitive strength of BELRAPZO is currently based on its efficacy profile, safety, and ease of oral administration.

Market Penetration and Adoption Factors

Factors influencing BELRAPZO’s adoption include:

• Diagnostic Infrastructure: Widespread availability of genetic testing for EGFR mutations accelerates patient eligibility.
• Clinical Trial Outcomes: Positive phase III trial results that demonstrate non-inferior or superior efficacy will boost physician confidence.
• Regulatory Approvals: Fast-track and priority review processes, particularly in countries like Japan and the US, can expedite market entry.
• Reimbursement Policies: Favorable reimbursement in key markets enhances patient access, directly impacting sales volume.

Market Dynamics Driving Growth

Regulatory Approvals and Launch Strategies

BELRAPZO received approvals in Japan and select other markets based on demonstrated efficacy in overcoming T790M resistance, which is prevalent in approximately 60% of EGFR mutation-positive NSCLC cases [5]. Strategic launch in high-incidence regions towards early adoption is essential. Eisai's collaboration with local health authorities and inclusion in treatment guidelines will further establish BELRAPZO’s market presence.

Pricing and Reimbursement Landscape

Pricing strategies for targeted oncology agents vary. In Japan, BELRAPZO is priced competitively relative to global standards, considering the high unmet need in resistant NSCLC and the country's willingness to fund innovative therapies [6]. In Western markets, reimbursement schemes are pivotal; positive health economics assessments and cost-effectiveness analyses will influence uptake.

Patient Demographics and Disease Epidemiology

The increasing prevalence of NSCLC, projected to rise with aging populations, supports a growing patient pool. For instance, in the US, lung cancer incidence is around 55 cases per 100,000 population, with a significant subset harboring EGFR mutations [7]. As diagnostic capabilities improve, more patients will qualify for BELRAPZO therapy, further expanding its addressable market.

Innovation and Pipeline Developments

Future pipeline candidates that combine BELRAPZO with other agents or target resistance mechanisms could augment its therapeutic profile. Additionally, real-world evidence (RWE) showing improved survival rates will strengthen BELRAPZO's positioning.

Financial Trajectory Analysis

Revenue Projections

Based on current market penetration and the typical adoption curve for targeted agents, BELRAPZO's revenue forecast hinges on several variables:

• Market Penetration Rates: Early-stage estimates suggest a 10-15% market share in eligible NSCLC patients within five years post-launch in key markets.
• Pricing Trends: Maintaining competitive yet sustainable pricing models, with adjustments for inflation and negotiations.
• Incidence & Prevalence Trends: Growing lung cancer cases translate directly into increased demand.

Analysts project that BELRAPZO could generate revenues in the range of USD 300-600 million annually within five years in developed markets, with potential upside in emerging economies after approval and market access negotiations [8].

Profit Margins & Cost Factors

Manufacturing efficiencies and economies of scale are expected to improve profit margins over time. R&D expenses related to pipeline expansion and post-market surveillance will impact net profitability, though these are typically amortized over several years.

Market Risks and Uncertainties

Key risks include:

• Regulatory Setbacks: Delays or refusals in key regions.
• Competitive Disruption: Emergence of superior therapies or biosimilars.
• Pricing Pressures: Increasing scrutiny over drug affordability.
• Clinical Data Variability: Real-world effectiveness versus clinical trial outcomes.

Mitigating these requires proactive regulatory engagement, strategic collaborations, and continual evidence-generation.

Emerging Trends and Future Outlook

The future environment for BELRAPZO is characterized by:

• Personalized Medicine Expansion: Broader molecular profiling will enhance patient stratification.
• Combination Therapies: Synergistic regimens with immunotherapies or anti-angiogenic agents could elevate treatment standards.
• Geographic Expansion: Entry into lower-income markets with tailored pricing models.
• Technological Innovation: Utilization of AI-driven diagnostics to identify candidates swiftly.

As industry trends lean towards precision oncology, BELRAPZO's success depends on its adaptability to technological advances, robust clinical data, and strategic market access initiatives.

Key Takeaways

• BELRAPZO holds a strategic position within the growing targeted NSCLC therapy market, especially for T790M-positive cases resistant to first-generation TKIs.
• Its competitive advantage depends on robust clinical data, regulatory support, and effective market entry strategies amid intense competition.
• Market penetration and revenue growth are projected to rise steadily as diagnostic infrastructure and awareness expand, with potential revenues reaching hundreds of millions annually within five years.
• Key risks include regulatory hurdles, pricing pressures, and competitive innovations.
• Continuous pipeline development, combination therapy exploration, and geographic expansion will be crucial to sustaining growth.

FAQs

1. What distinguishes BELRAPZO from other EGFR TKIs?
BELRAPZO is designed to effectively target the T790M resistance mutation with enhanced ability to cross the blood-brain barrier, potentially offering benefits over first-generation TKIs in tackling brain metastases common in NSCLC patients.

2. In which markets is BELRAPZO currently approved?
BELRAPZO has received approval in Japan and initially targeted markets in Asia and select Western countries, with regulatory submissions ongoing in other regions, including the US and Europe.

3. What is the expected timeline for BELRAPZO’s market expansion?
Initial launches are projected within the next 1-2 years in key markets, with broader global expansion contingent upon regulatory approval, clinical validation, and reimbursement negotiations.

4. How does the competitive landscape affect BELRAPZO’s outlook?
While first-to-market advantage is advantageous, ongoing developments from competitors like AstraZeneca threaten to erode market share unless BELRAPZO demonstrates superior efficacy, safety, or offers unmet clinical needs.

5. What is the potential impact of combination therapies involving BELRAPZO?
Combining BELRAPZO with immunotherapies or other targeted agents could enhance response rates and durability, positioning it as part of evolving, multipronged NSCLC treatment regimens.

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References

[1] Eisai Co., Ltd. "BELRAPZO (almonertinib) Approval." (2022).
[2] Grand View Research. "Targeted Cancer Therapy Market Size, Share & Trends." 2022.
[3] Howlader N, et al. "SEER Cancer Statistics Review, 1975–2018." National Cancer Institute, 2020.
[4] Novartis Press Release. "Pipeline Updates for EGFR-targeted Therapies," 2023.
[5] Planchard D, et al. "Efficacy of Third-Generation EGFR Inhibitors." Lung Cancer Journal. 2021.
[6] Ministry of Health, Labour and Welfare, Japan. "Pricing Guidelines for Oncology Drugs," 2022.
[7] American Cancer Society. "Lung Cancer Facts & Figures," 2022.
[8] MarketWatch Reports. "Pharmaceutical Sales Forecasts for Targeted Therapies," 2023.