BENDEKA Drug Patent Profile

Which patents cover Bendeka, and what generic alternatives are available?

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

This drug has one hundred and twenty-four patent family members in thirty-one countries.

The generic ingredient in BENDEKA 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 Bendeka

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

Summary for BENDEKA

International Patents:	124
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	21
Drug Prices:	Drug price information for BENDEKA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENDEKA
What excipients (inactive ingredients) are in BENDEKA?	BENDEKA excipients list
DailyMed Link:	BENDEKA at DailyMed

See drug prices for BENDEKA

Recent Clinical Trials for BENDEKA

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

Sponsor	Phase
University of Wisconsin, Madison	Phase 1/Phase 2
Epizyme, Inc.	Phase 1/Phase 2
Vaishalee Kenkre	Phase 1/Phase 2

See all BENDEKA clinical trials

Pharmacology for BENDEKA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for BENDEKA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BENDEKA	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	208194	1	2017-05-04

US Patents and Regulatory Information for BENDEKA

BENDEKA is protected by twenty-eight 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	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes			Y

International Patents for BENDEKA

When does loss-of-exclusivity occur for BENDEKA?

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

Argentina

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Hong Kong

Japan

Malaysia

Mexico

New Zealand

Norway

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

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 BENDEKA around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	101648495
Canada	2867343	METHODE DE TRAITEMENT DES ETATS REAGISSANT A LA BENDAMUSTINE CHEZ DES PATIENTS NECESSITANT DES VOLUMES REDUITS POUR L'ADMINISTRATION (METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION)
Japan	2021178846	ベンダムスチンの製剤 (FORMULATIONS OF BENDAMUSTINE)
South Korea	20180056804	동결건조를 위한 벤다무스틴 약학 조성물 (BENDAMUSTINE PHARMACEUTICAL COMPOSITIONS FOR LYOPHILISATION)
Spain	2609106

BENDEKA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for BENDEKA

Introduction

BENDEKA, a formulation of bendamustine, is a crucial drug in the treatment of chronic lymphocytic leukemia (CLL) and other hematological malignancies. Developed by Eagle Pharmaceuticals in partnership with Teva Pharmaceutical Industries, BENDEKA has shown significant market presence and financial performance over the years.

Market Share and Dominance

As of 2016, BENDEKA achieved a remarkable 71% total market share, with a particularly strong presence in the core hospital outpatient and clinic segments, capturing 77% of this market[1]. This dominance was further solidified by favorable patent litigation decisions, including a U.S. District Court ruling that upheld the validity and infringement of BENDEKA's patent claims, preventing generic competitors from entering the market until 2031[2].

Financial Performance

Revenue and Sales

In the first quarter of 2016, BENDEKA contributed significantly to Eagle Pharmaceuticals' revenue, with $10.3 million in net product sales. This was a substantial increase from the previous year, driving overall product sales to $14.1 million[1].

By 2020, despite a slight decline in overall revenue, BENDEKA continued to be a major revenue driver. The total revenue for Q1 2020 was $46.0 million, with BENDEKA sales contributing to the royalty revenue, which was $28.3 million[2].

Royalty Income

The launch of BENDEKA also led to a significant increase in royalty income. In the first quarter of 2016, royalty income rose by $6.2 million to $9.5 million, primarily due to the BENDEKA launch[1].

Gross Margin and Profitability

The gross margin for Eagle Pharmaceuticals expanded in 2020, partly due to the higher sales of RYANODEX and the royalty revenue from BENDEKA. The gross margin was 83% in Q1 2020, up from 74% in Q1 2019[2].

Regulatory and Legal Milestones

Patent Protection and Orphan Drug Exclusivity

BENDEKA has benefited from robust regulatory and legal protections. A U.S. Court of Appeals decision affirmed the FDA's recognition of seven years of orphan drug exclusivity for BENDEKA, ensuring that no other bendamustine products for the same indication could enter the market unless clinically superior before 2022[2].

Extended Patent Protection

The favorable patent litigation decision extended the patent protection for BENDEKA until 2031, significantly reducing the threat of generic competition during this period[2].

Market Drivers and Restraints

Growing Prevalence of CLL and Other Hematological Malignancies

The bendamustine market, including BENDEKA, is driven by the growing prevalence of chronic lymphocytic leukemia, Non-Hodgkin’s lymphoma, and multiple myeloma. This increasing patient population, particularly in North America and Europe, has been a key factor in the market growth[4].

Side Effects and Awareness

Despite the market growth, side effects associated with bendamustine, such as vomiting, diarrhea, fever, and weight loss, are significant restraints. Limited awareness among the population about available treatments also hampers market expansion[4].

Geographic Performance

North America and Europe

North America is expected to lead the bendamustine market, including BENDEKA, due to the high prevalence of CLL and other relevant cancers. Europe follows closely, driven by the growing demand for bendamustine treatments[4].

Asia Pacific and Other Regions

The Asia Pacific region is projected to expand at the highest CAGR due to an empowered healthcare industry and increasing incidences of CLL and other hematological malignancies. However, Latin America and the Middle East & Africa are expected to have slower growth rates, though improving healthcare sectors in these regions are contributing to market expansion[4].

Future Outlook and Guidance

Manageable Decline and Diversified Revenue

Eagle Pharmaceuticals expects the U.S. bendamustine franchise, including BENDEKA, to experience a manageable decline in 2023, maintaining approximately 75% of the gross profit. The company is diversifying its revenue stream, with expected increases in PEMFEXY sales and contributions from newer hospital-based products like Barhemsys and Byfavo[3].

Elimination of Royalties

The expiration of development partner royalties on the bendamustine franchise profits in Q4 2022 and the reduction of future royalties on PEMFEXY profits are expected to enhance profitability. Eagle Pharmaceuticals bought down future royalties on PEMFEXY profits with a one-time payment of $15 million, reducing the royalty rate from 25% to a range of 0% to 12.5% based on aggregate profits[3].

Key Takeaways

• Market Dominance: BENDEKA has achieved significant market share and dominance in the treatment of CLL.
• Financial Performance: The drug has been a major contributor to Eagle Pharmaceuticals' revenue and profitability.
• Regulatory Protections: BENDEKA benefits from extended patent protection and orphan drug exclusivity.
• Market Drivers: Growing prevalence of CLL and other hematological malignancies drive the market.
• Future Outlook: The company expects a manageable decline in the bendamustine franchise while diversifying its revenue stream.

FAQs

What is BENDEKA used for?

BENDEKA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) and other hematological malignancies[5].

What was the market share of BENDEKA in 2016?

BENDEKA achieved a 71% total market share in 2016, with a 77% share in core hospital outpatient and clinic segments[1].

How has the regulatory environment impacted BENDEKA?

Favorable patent litigation decisions and orphan drug exclusivity have extended the market exclusivity of BENDEKA until 2031 and ensured no clinically inferior products can enter the market before 2022[2].

What are the key drivers of the bendamustine market?

The growing prevalence of CLL, Non-Hodgkin’s lymphoma, and multiple myeloma are key drivers of the bendamustine market, including BENDEKA[4].

How does Eagle Pharmaceuticals plan to manage the decline in the bendamustine franchise?

Eagle Pharmaceuticals expects a manageable decline in the U.S. bendamustine franchise, maintaining approximately 75% of the gross profit, and is diversifying its revenue stream through other products like PEMFEXY, Barhemsys, and Byfavo[3].

Sources

1. Eagle Pharmaceuticals Inc. Reports First Quarter 2016 Results - Investor Eagle US
2. Eagle Pharmaceuticals Reports First Quarter 2020 Results - Business Wire
3. Eagle Pharmaceuticals Provides Business Update and Guidance for 2023 - GlobeNewswire
4. Bendamustin Market Size, Industry Share, Forecast 2032 - Fortune Business Insights
5. Patient Access and Reimbursement Services | BENDEKA - Bendeka HCP