You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 22, 2024

BENDAMUSTINE HYDROCHLORIDE Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Bendamustine Hydrochloride, and what generic alternatives are available?

Bendamustine Hydrochloride is a drug marketed by Accord Hlthcare, Apotex, Breckenridge, Dr Reddys, Eugia Pharma, Meitheal, Nang Kuang Pharm Co, Norvium Bioscience, Baxter Hlthcare Corp, and Hospira. and is included in eleven NDAs.

The generic ingredient in BENDAMUSTINE HYDROCHLORIDE 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 Bendamustine Hydrochloride

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

  Subscribe

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for BENDAMUSTINE HYDROCHLORIDE?
  • What are the global sales for BENDAMUSTINE HYDROCHLORIDE?
  • What is Average Wholesale Price for BENDAMUSTINE HYDROCHLORIDE?
Drug patent expirations by year for BENDAMUSTINE HYDROCHLORIDE
Recent Clinical Trials for BENDAMUSTINE HYDROCHLORIDE

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

SponsorPhase
Stanford UniversityPhase 1
Kyverna TherapeuticsPhase 1
Mayo ClinicPhase 1

See all BENDAMUSTINE HYDROCHLORIDE clinical trials

Pharmacology for BENDAMUSTINE HYDROCHLORIDE
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for BENDAMUSTINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for BENDAMUSTINE HYDROCHLORIDE
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
Accord Hlthcare BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 205574-001 Dec 7, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare Corp BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride SOLUTION;INTRAVENOUS 216078-001 Dec 15, 2022 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 205376-001 Dec 7, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 204230-002 Jun 5, 2023 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Meitheal BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 211001-002 Jun 5, 2023 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Hospira BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride SOLUTION;INTRAVENOUS 211530-002 Dec 15, 2022 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys BENDAMUSTINE HYDROCHLORIDE bendamustine hydrochloride POWDER;INTRAVENOUS 205376-002 Dec 7, 2022 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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].

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.