BENDAMUSTINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for bendamustine hydrochloride and what is the scope of freedom to operate?

Bendamustine hydrochloride is the generic ingredient in five branded drugs marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Pharmobedient, Cephalon, Eagle Pharms, Baxter Hlthcare Corp, Hospira, and Azurity, and is included in sixteen NDAs. There are thirty-one patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Bendamustine hydrochloride has one hundred and fifty-seven patent family members in thirty-two countries.

There are sixteen drug master file entries for bendamustine hydrochloride. Eleven suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for BENDAMUSTINE HYDROCHLORIDE

International Patents:	157
US Patents:	31
Tradenames:	5
Applicants:	13
NDAs:	16
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	408
Patent Applications:	7,711
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENDAMUSTINE HYDROCHLORIDE
What excipients (inactive ingredients) are in BENDAMUSTINE HYDROCHLORIDE?	BENDAMUSTINE HYDROCHLORIDE excipients list
DailyMed Link:	BENDAMUSTINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for BENDAMUSTINE HYDROCHLORIDE

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

Sponsor	Phase
Fred Hutchinson Cancer Center	PHASE1
Guangzhou Lupeng Pharmaceutical Company LTD.	PHASE2
Dizal (Jiangsu) Pharmaceutical Co., Ltd.	PHASE3

See all BENDAMUSTINE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for BENDAMUSTINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		100MG/VIAL	POWDER;IV (INFUSION)
		25MG/VIAL	POWDER;IV (INFUSION)
		100MG/VIAL	POWDER;IV (INFUSION)

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for BENDAMUSTINE HYDROCHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for BENDAMUSTINE HYDROCHLORIDE

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for BENDAMUSTINE HYDROCHLORIDE

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BENDAMUSTINE HYDROCHLORIDE

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
BENDEKA	Injection	bendamustine hydrochloride	100 mg/4 mL (25 mg/mL) multiple-dose vials	208194	1	2017-05-04
TREANDA	Injection	bendamustine hydrochloride	90 mg/mL, 0.5 mL and 2 mL in single- dose vials	022249	1	2014-06-19
TREANDA	Injection	bendamustine hydrochloride	25 mg/vial and 100 mg/vial	022249	10	2013-06-04

US Patents and Regulatory Information for BENDAMUSTINE HYDROCHLORIDE

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	12,138,248		Y
Cephalon	TREANDA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	022249-004	Sep 13, 2013		DISCN	Yes	No	8,344,006*PED				Y
Breckenridge	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	205447-002	Feb 14, 2023		DISCN	No	No
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes	8,895,756*PED				Y
Eagle Pharms	BENDEKA	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	208194-001	Dec 7, 2015		RX	Yes	Yes	12,350,257		Y
Dr Reddys	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	SOLUTION;INTRAVENOUS	219014-001	Jul 3, 2025		DISCN	Yes	No

International Patents for BENDAMUSTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Japan	2018070624	ベンダムスチンの製剤 (FORMULATIONS OF BENDAMUSTINE)
Chile	2009000742	Forma solida cristalina de clorhidrato de bendamustina, designada como forma 1; composicion farmaceutica que la comprende; metodo de preparacion de la composicion farmaceutica; y uso en el tratamiento de leucemia linfocitica cronica, enfermedad de hodgkin, linfoma no hodgkiniano, mieloma multiple o cancer de mama.
European Patent Office	2889029
European Patent Office	4218756	PROCÉDÉ DE TRAITEMENT DE CONDITIONS SENSIBLES À LA BENDAMUSTINE CHEZ DES PATIENTS NÉCESSITANT DES VOLUMES RÉDUITS POUR ADMINISTRATION (METHOD OF TREATING BENDAMUSTINE-RESPONSIVE CONDITIONS IN PATIENTS REQUIRING REDUCED VOLUMES FOR ADMINISTRATION)
Japan	5536753
World Intellectual Property Organization (WIPO)	2009120386

Market Dynamics and Financial Trajectory for BENDAMUSTINE HYDROCHLORIDE

Last updated: September 22, 2025

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Introduction

Bendamustine Hydrochloride is a notable chemotherapeutic agent integrating alkylating properties with antimetabolite activity, primarily indicated for certain hematological malignancies, including chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL). Since its commercialization, bendamustine's unique efficacy profile and expanding indications have considerably influenced its market dynamics and financial outlook within the oncology therapeutics segment. This analysis evaluates the key drivers shaping its market trajectory, competitive landscape, regulatory factors, and financial projections through 2030.

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Market Landscape and Demand Drivers

Epidemiological Trends and Therapeutic Adoption

The rising global incidence of hematological cancers significantly fuels demand for bendamustine. According to the World Health Organization (WHO), leukemia and lymphoma incidences are increasing, particularly in aging populations. In the US alone, the American Cancer Society estimates about 19,550 new cases of leukemia and 77,240 cases of lymphoma in 2023, underscoring a persistent unmet need.

Bendamustine's adoption expands due to its advantageous efficacy and tolerability relative to traditional chemotherapeutics. It often features in combination chemotherapies—e.g., bendamustine with rituximab (BR regimen)—which are standard of care in many settings, further bolstering sales.

Regulatory Approvals and Expansion of Indications

Initially approved by the FDA in 2013 for chronic lymphocytic leukemia, subsequent approvals in various countries and expanded indications—including indolent non-Hodgkin's lymphoma—broadened its patient cohort. Regulatory authorities are also evaluating potential uses in multiple myeloma and other hematological conditions, promising future growth avenues.

Competitive Dynamics

Bendamustine faces competition from other chemotherapeutic agents and targeted therapies such as rituximab, obinutuzumab, and newer immunotherapies, including CAR-T cells. However, its established efficacy, manageable safety profile, and cost-effectiveness continue to underpin its market positioning.

Biotechnology firms and generic manufacturers increasingly pursue biosimilars and generics, exerting downward pressure on pricing but simultaneously expanding accessibility, especially in emerging markets.

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Market Size and Revenue Trajectory

Current Market Valuation

As of 2022, the global bendamustine market size was approximately USD 1.2 billion, with a compound annual growth rate (CAGR) of roughly 7% since 2018. North America commands the largest share (~45%), driven by high patent protection, advanced healthcare infrastructure, and high adoption rates.

Projected Growth Dynamics

Analysts project the market will reach USD 2.0 billion by 2030, with a CAGR of about 8% through 2030. Drivers include:

• Increasing prevalence of hematological malignancies.
• Broader indications approved through ongoing clinical trials.
• Rising adoption of combination regimens.
• Expansion into emerging markets, such as China and India, where healthcare reforms improve drug access.

The advent of biosimilars and generics could challenge pricing dynamics, but overall sales are expected to benefit from volume growth and geographical expansion.

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Regulatory and Policy Factors

Regulatory policies significantly influence market expansion. Accelerated approval pathways, orphan drug designations, and favorable reimbursement policies accelerate product penetration, particularly in developing nations.

Conversely, patent expirations, which are anticipated in the next 3-5 years for some formulations, might erode exclusivity revenues but also stimulate competition and drive sales volumes.

Pricing Strategies and Reimbursement

Pricing remains a key element of financial performance. While the original patented formulations commanded premium pricing, biosimilar entrants are decreasing drug prices, especially in Europe and Asia. Reimbursement coverage, especially under national health schemes, determines patient access and impacts revenue streams.

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Innovation and Future Outlook

Ongoing clinical research is evaluating bendamustine in combination with novel agents like Venetoclax and Ibrutinib, potentially increasing its role in first-line therapy. Additionally, trials exploring its utility in other hematoxietic disorders could open new markets.

Technology advancements, such as precision medicine and biomarker-driven therapy, might refine patient selection for bendamustine treatment, optimizing outcomes and financial returns.

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Risks and Challenges

• Patent cliffs and biosimilar competition threaten profit margins.
• Market saturation in mature regions may slow growth.
• Regulatory hurdles in emerging markets require strategic navigation.
• Clinical trial failures or adverse safety profiles could limit expansion.

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Financial Projections and Investment Outlook

Based on current trends and pipeline development, manufacturers and investors can expect:

• Continued moderate CAGR (~8%) driven by increasing global demand.
• Expansion into new indications and markets bolstering revenue streams.
• Potential price erosion from biosimilars balanced by volume growth.

Strategic collaborations, patent management, and clinical pipeline diversification will be crucial for sustained financial performance.

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Key Takeaways

• The global bendamustine market is poised for steady growth, predominantly fueled by rising hematological cancer cases and expanding indications.
• North America dominates the market but emerging economies present substantial growth potential.
• Competition from generics and biosimilars will influence pricing, necessitating strategic positioning.
• Ongoing clinical trials and pipeline expansion could unlock new therapeutic uses, boosting future revenues.
• Regulatory environments and reimbursement policies remain critical determinants of market accessibility and profitability.

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FAQs

Q1: What are the primary indications for bendamustine hydrochloride?
A: Its primary indications include chronic lymphocytic leukemia and indolent non-Hodgkin’s lymphoma, often in combination with rituximab.

Q2: How does biosimilar entry affect the bendamustine market?
A: Biosimilar competition tends to lower prices and expand access, which, while reducing revenues per unit, can increase overall sales volume and market penetration.

Q3: What are the key drivers for growth in emerging markets?
A: Improving healthcare infrastructure, expanding healthcare coverage, rising cancer prevalence, and regulatory reforms facilitate growth in regions like China and India.

Q4: Are there ongoing clinical trials for new indications?
A: Yes, clinical trials are evaluating bendamustine's efficacy in multiple myeloma, mantle cell lymphoma, and as part of novel combination therapies.

Q5: How will patent expirations influence market revenues?
A: Patent expirations could lead to increased generic competition and price reductions, but overall sales might sustain due to growing demand and expanded use cases before patent cliffs.

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References

[1] World Health Organization. Cancer Data. 2023.
[2] American Cancer Society. Cancer Statistics, 2023.
[3] MarketWatch. Global Bendamustine Market Size & Trends, 2022.
[4] Research and Markets. Oncology Drugs Market Report, 2023.
[5] FDA. Bendamustine Hydrochloride Approval Details. 2013.