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, Norvium Bioscience, Cephalon, Eagle Pharms, Baxter Hlthcare Corp, Hospira, and Azurity, and is included in fifteen NDAs. There are twenty-eight 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-six 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:	156
US Patents:	28
Tradenames:	5
Applicants:	13
NDAs:	15
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	130
Clinical Trials:	359
Patent Applications:	3,433
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
Stanford University	Phase 1
Kyverna Therapeutics	Phase 1
Mayo Clinic	Phase 1

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
Norvium Bioscience	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	204104-001	Apr 28, 2023		DISCN	No	No
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
Nang Kuang Pharm Co	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	206554-002	Jun 7, 2023		DISCN	No	No
Apotex	BENDAMUSTINE HYDROCHLORIDE	bendamustine hydrochloride	POWDER;INTRAVENOUS	204230-002	Jun 5, 2023	AP	RX	No	No
Cephalon	TREANDA	bendamustine hydrochloride	POWDER;INTRAVENOUS	022249-002	May 1, 2009	AP	RX	Yes	Yes					Y

International Patents for BENDAMUSTINE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Spain	2609106
Japan	5536753
European Patent Office	2889029	Formulations liquides de bendamustine (Liquid formulations of bendamustine)
Japan	5688195
Japan	2022141895	ベンダムスチンの製剤
Portugal	3533447

BENDAMUSTINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Bendamustine Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

The bendamustine hydrochloride market is poised for significant growth, driven by several key factors. As of 2023, the market was valued at approximately USD 2.3 billion and is anticipated to reach USD 4.1 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2033[1].

Market Drivers

Several factors are driving the growth of the bendamustine hydrochloride market:

Increasing Prevalence of Hematological Malignancies

The escalating incidence of cancers such as non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), and multiple myeloma is a primary driver. This increasing number of diagnoses necessitates effective treatment options, thereby driving demand for bendamustine[1][4].

Improvements in Healthcare Infrastructure and Patient Awareness

Enhancements in healthcare infrastructure and growing patient awareness regarding cancer treatments have significantly contributed to market growth. The favorable safety profile of bendamustine, which leads to broader clinical application, is another key factor[1].

Updated Treatment Guidelines and Clinical Trials

Updated treatment guidelines that recommend the use of bendamustine in various treatment regimens bolster its market presence. Additionally, the increasing number of clinical trials focused on exploring bendamustine's potential in combination therapies signals strong market momentum[1].

Market Opportunities

The bendamustine hydrochloride market presents several lucrative opportunities:

Expansion in Combination Therapies

Ongoing research into the drug's efficacy in combination therapies offers significant potential for expanding its use beyond current indications. As clinical evidence accumulates, healthcare providers may increasingly incorporate bendamustine into multi-drug regimens[1].

Personalized Medicine

The growing emphasis on personalized medicine provides an avenue for bendamustine to be tailored to specific patient populations, improving treatment outcomes and enhancing patient satisfaction[1].

Emerging Markets

The expansion of healthcare access in emerging markets offers another significant growth opportunity, as more patients gain access to effective cancer therapies. Countries like China and India are expected to experience substantial growth as healthcare access expands[1].

Innovations in Formulations and Delivery Methods

Collaborations between pharmaceutical companies and research institutions can foster innovation in bendamustine formulations and delivery methods. For example, the development of ready-to-dilute (RTD) and rapid infusion (RI) products aims to reduce dispensing workload and administration time, enhancing patient convenience and compliance[2].

Regional Analysis

The regional dynamics of the bendamustine hydrochloride market exhibit diverse growth patterns:

North America

North America holds a dominant position, driven by high healthcare expenditures, advanced medical infrastructure, and robust regulatory support. The United States, in particular, demonstrates strong demand due to a high prevalence of hematological cancers and favorable reimbursement policies[1].

Europe

Europe follows closely, with key markets such as Germany, France, and the UK showcasing significant growth, supported by strong healthcare systems and increasing awareness of cancer treatment options[1].

Asia-Pacific

The Asia-Pacific region is emerging as a critical growth area, fueled by rising cancer incidence, improving healthcare infrastructure, and increasing disposable incomes. Countries like China and India are expected to experience substantial growth as healthcare access expands[1].

Latin America and Middle East

Regions such as Latin America and the Middle East face challenges related to economic conditions and healthcare disparities, which may slow market growth but still offer potential opportunities for expansion as access to treatments improves[1].

Financial Trajectory

Revenue Growth

The market is expected to grow from USD 2.3 billion in 2023 to USD 4.1 billion by 2033, with a CAGR of 5.8%. This growth is driven by increasing sales and expanding indications for bendamustine hydrochloride[1].

Sales Performance

Companies like SymBio Pharmaceuticals have seen significant sales growth due to the progress in market penetration of bendamustine as a first-line treatment for low-grade NHL and MCL. For instance, SymBio reported sales of JPY3.6 billion in Japan, exceeding previous forecasts, following the approval for new indications[2].

Profit Margins

While sales growth is robust, profit margins can be influenced by various factors such as research and development expenses, licensing agreements, and the transition to more convenient formulations like RTD and RI products. SymBio, for example, has managed SG&A expenses within budget but faced increased R&D expenses and upfront payments for licensing agreements[2].

Future Outlook

The future outlook for the bendamustine hydrochloride market is promising:

Sustained Growth

The rising incidence of hematological malignancies and the increasing demand for effective cancer therapies are expected to drive market expansion. Ongoing advancements in pharmaceutical research and technology will likely lead to the development of new formulations and combination therapies, further enhancing bendamustine's market position[1].

Innovations and Expansions

The emphasis on personalized medicine and the growing access to healthcare in emerging markets present significant opportunities for growth. As the oncology landscape continues to evolve, bendamustine is expected to maintain a prominent role in cancer treatment, positioning the market for long-term success[1].

Key Takeaways

• The bendamustine hydrochloride market is projected to grow from USD 2.3 billion in 2023 to USD 4.1 billion by 2033 at a CAGR of 5.8%.
• The market is driven by the increasing prevalence of hematological malignancies, improvements in healthcare infrastructure, and favorable treatment guidelines.
• North America and Europe are leading regions, with the Asia-Pacific region emerging as a significant growth area.
• Innovations in formulations and delivery methods, along with expanding healthcare access in emerging markets, offer lucrative growth opportunities.
• The future outlook is promising, with sustained growth anticipated due to ongoing research and advancements in cancer therapies.

FAQs

Q: What is the current market size of bendamustine hydrochloride and its projected growth? A: The bendamustine hydrochloride market was valued at approximately USD 2.3 billion in 2023 and is anticipated to reach USD 4.1 billion by 2033, growing at a CAGR of 5.8% from 2024 to 2033[1].

Q: What are the primary drivers of the bendamustine hydrochloride market? A: The primary drivers include the escalating incidence of hematological malignancies, improvements in healthcare infrastructure, and favorable treatment guidelines. Additionally, the growing acceptance of bendamustine among oncologists due to its relatively favorable safety profile is a significant factor[1].

Q: Which regions are leading the bendamustine hydrochloride market? A: North America holds a dominant position, followed by Europe. The Asia-Pacific region is emerging as a critical growth area due to rising cancer incidence and improving healthcare infrastructure[1].

Q: What are the potential opportunities for growth in the bendamustine hydrochloride market? A: Opportunities include expanding indications through combination therapies, personalized medicine, and increasing healthcare access in emerging markets. Innovations in formulations and delivery methods also present significant growth opportunities[1].

Q: What are the potential restraints to the bendamustine hydrochloride market? A: Side effects associated with the drug, such as vomiting, diarrhea, fever, and weight loss, are major factors likely to restrict market growth. Limited awareness among the population about available treatments is another restraint[4].

Sources

1. Data Horizon Research: Bendamustine Hydrochloride for Injection Market Size, Growth and Forecast 2024-2033[1].
2. SymBio Pharmaceuticals: Research Coverage Report by Shared Research Inc.[2].
3. Market Research Future: Bendamustine Market Size, Share, Growth Report 2032[3].
4. Fortune Business Insights: Bendamustin Market Size, Industry Share, Forecast 2032[4].
5. PBS Australia: Bendamustine for the treatment of lymphoma - PBS[5].