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 ten 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:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
Drug Prices:	Drug price information 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
National Cancer Institute (NCI)	Phase 1
City of Hope Medical Center	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 seventeen 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			Y
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes
Eagle Pharms	BELRAPZO	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	205580-001	May 15, 2018	AP	RX	Yes	Yes			Y

International Patents for BELRAPZO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2593582	COMPOSITIONS PHARMACEUTIQUES DE BENDAMUSTINE (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Japan	2013056901	BENDAMUSTINE PHARMACEUTICAL COMPOSITION
Serbia	55491	FORMULACIJE BENDAMUSTINA (FORMULATIONS OF BENDAMUSTINE)

Market Dynamics and Financial Trajectory for BELRAPZO

Introduction

BELRAPZO, a ready-to-dilute (RTD) formulation of bendamustine, is a crucial product in Eagle Pharmaceuticals' oncology portfolio. This article delves into the market dynamics and financial performance of BELRAPZO, highlighting its significance, market share, revenue trends, and future outlook.

Market Significance of BELRAPZO

BELRAPZO is part of Eagle Pharmaceuticals' bendamustine franchise, which also includes BENDEKA and TREAKISYM. Bendamustine is a chemotherapy drug used in the treatment of certain types of cancer, including chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL)[4].

Market Share

As of the second quarter of 2023, BELRAPZO and BENDEKA combined held approximately 84% of the bendamustine U.S. market. This dominant market share underscores the strong position of Eagle Pharmaceuticals in the oncology sector[2].

Revenue Trends

Quarterly Performance

In the second quarter of 2023, BELRAPZO continued to perform well. The gross profit from the U.S. bendamustine franchise, which includes BELRAPZO, was $41.9 million, representing a gross margin of 80%. This is an improvement from the $38.7 million gross profit and 72% gross margin in the prior year period[2].

Annual Performance

For the full year 2022, the bendamustine franchise saw significant growth. The gross profit from this franchise increased by $2.7 million or 11% compared to the fourth quarter of 2021. BELRAPZO's net product sales in the fourth quarter of 2022 were $11.0 million, up from $5.5 million in the fourth quarter of 2021[4].

Financial Highlights

Revenue Growth

• In Q1 2020, BELRAPZO product sales were $4.6 million, compared to $3.2 million in Q1 2019, indicating a growing trend[3].
• By Q4 2022, BELRAPZO's net product sales had increased to $11.0 million, reflecting a substantial growth trajectory[4].

Gross Margin

• The gross margin for the bendamustine franchise, including BELRAPZO, was 80% in the second quarter of 2023, up from 72% in the prior year period. Adjusted non-GAAP gross margin was even higher at 84% for the same period[2].

Overall Financial Impact

• The total revenue from the bendamustine franchise contributes significantly to Eagle Pharmaceuticals' overall financial performance. For instance, in 2022, the total revenue from product sales, including BELRAPZO, was $214.5 million, a substantial increase from $65.0 million in 2021[4].

Competitive Landscape

BELRAPZO operates in a competitive oncology market, but its ready-to-dilute formulation provides a significant advantage. This formulation simplifies the preparation process for healthcare professionals, enhancing patient care and compliance.

Future Outlook

Growth Expectations

Eagle Pharmaceuticals anticipates continued growth for its bendamustine franchise, including BELRAPZO. The company's strong sales momentum and commercial infrastructure are expected to drive further expansion in the market[2].

Strategic Initiatives

• The company plans to leverage its commercial infrastructure and working capital to add complementary products, either through research and development or acquisition. This strategy is likely to further solidify BELRAPZO's position in the market[2].

Regulatory and Market Factors

• The affirmation of extended patent protection and orphan drug exclusivity for BENDEKA, another product in the bendamustine franchise, also positively impacts BELRAPZO by protecting the franchise's market share[3].

Key Takeaways

• Dominant Market Share: BELRAPZO and BENDEKA combined hold approximately 84% of the bendamustine U.S. market.
• Revenue Growth: Significant increases in BELRAPZO's net product sales and gross profit margins.
• Financial Performance: Contribution to Eagle Pharmaceuticals' overall revenue and profitability.
• Competitive Advantage: Ready-to-dilute formulation enhances patient care and compliance.
• Future Outlook: Anticipated continued growth and strategic initiatives to expand market presence.

FAQs

What is BELRAPZO used for?

BELRAPZO is used in the treatment of certain types of cancer, including chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).

What is the market share of BELRAPZO and BENDEKA in the U.S.?

As of the second quarter of 2023, BELRAPZO and BENDEKA combined held approximately 84% of the bendamustine U.S. market.

How has the revenue from BELRAPZO changed over the past few years?

BELRAPZO's net product sales have shown significant growth, increasing from $4.6 million in Q1 2020 to $11.0 million in Q4 2022.

What are the key factors driving the growth of BELRAPZO?

The growth of BELRAPZO is driven by its ready-to-dilute formulation, strong commercial infrastructure, and the company's strategic initiatives to expand its market presence.

What are the future expectations for BELRAPZO?

Eagle Pharmaceuticals expects continued growth for its bendamustine franchise, including BELRAPZO, driven by its sales momentum and strategic initiatives.

Sources

1. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - GlobeNewswire
2. Eagle Pharmaceuticals Reports Second Quarter 2023 Results - Eagle Pharmaceuticals Investor Relations
3. Eagle Pharmaceuticals Reports First Quarter 2020 Results - Business Wire
4. Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2022 - Eagle Pharmaceuticals Investor Relations
5. Annual Report 2022 - Eagle Pharmaceuticals, Inc. - Eagle Pharmaceuticals Investor Relations