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Last Updated: December 22, 2024

LOMUSTINE - Generic Drug Details


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What are the generic sources for lomustine and what is the scope of patent protection?

Lomustine is the generic ingredient in one branded drug marketed by Latina Pharma and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for lomustine. One supplier is listed for this compound.

Summary for LOMUSTINE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 116
Clinical Trials: 107
Patent Applications: 7,373
What excipients (inactive ingredients) are in LOMUSTINE?LOMUSTINE excipients list
DailyMed Link:LOMUSTINE at DailyMed
Recent Clinical Trials for LOMUSTINE

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

SponsorPhase
Darell BignerPhase 2
Istari Oncology, Inc.Phase 2
CarTheraPhase 3

See all LOMUSTINE clinical trials

Pharmacology for LOMUSTINE
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories for LOMUSTINE

US Patents and Regulatory Information for LOMUSTINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Latina Pharma GLEOSTINE lomustine CAPSULE;ORAL 017588-003 Approved Prior to Jan 1, 1982 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Latina Pharma GLEOSTINE lomustine CAPSULE;ORAL 017588-004 Dec 19, 2014 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Latina Pharma GLEOSTINE lomustine CAPSULE;ORAL 017588-002 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  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

LOMUSTINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lomustine

Introduction to Lomustine

Lomustine, also known as CCNU and marketed as Gleostine, is a chemotherapy drug used to treat various types of cancer, including brain tumors, melanoma, and lymphomas. It works by damaging the DNA of cancer cells, preventing their growth and division.

Market Overview

The global Lomustine market is poised for significant growth driven by several key factors:

  • Increasing Cancer Incidence: The rising incidence of cancers, particularly brain tumors and lymphomas, is a major driver. Early detection and advancements in oncology treatments are leading to higher demand for effective therapies like Lomustine[1].
  • Advancements in Oncology: Improvements in healthcare infrastructure, especially in emerging markets, and the role of Lomustine in combination therapies and targeted treatments further support market growth[1].
  • Government Policies and Funding: Supportive government policies and funding for cancer research contribute to the market's expansion[1].

Market Size and Growth Projections

The global Lomustine market is expected to grow at a compound annual growth rate (CAGR) of a significant percentage from 2024 to 2034. By the end of this period, the market is projected to reach a substantial value in USD million. In 2024, the market size is estimated to be around USD million[1].

Regional Analysis

North America

North America dominates the Lomustine market, holding more than 48% of the market share. This dominance is attributed to advanced healthcare infrastructure, high cancer prevalence, and substantial investments in research and development. The favorable regulatory environment and the presence of leading pharmaceutical companies in the United States and Canada also contribute to this region's leading position[1].

Europe

Europe's Lomustine market is supported by high cancer incidence rates and a well-established healthcare system. Countries like Germany, the UK, and France are key players, with strong government policies encouraging pharmaceutical research and innovation. Despite economic challenges, the region's focus on improving cancer treatment outcomes ensures steady market growth[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. Economic growth, increasing cancer prevalence, and improving healthcare infrastructure in countries like China, India, and Japan drive this growth. Rising disposable incomes and growing awareness about cancer treatments also contribute to higher demand in this region[1].

Key Market Players

The Lomustine market is dominated by a few large companies, including:

  • Medicon Pharma
  • Nanjing Pharma
  • Bristol-Myers Squibb
  • NextSource Pharma
  • Ther Dose
  • Other players[1].

Price Dynamics and Access Issues

Price Gouging and Medicare Coverage

NextSource Pharmaceuticals, the sole manufacturer of Lomustine in the U.S., has been criticized for significantly increasing the drug's price. Since acquiring the rights to Lomustine in 2013, NextSource has raised the price by over 1,900% in just eight years. This has led to the drug being withdrawn from Medicare coverage, leaving many patients, especially those with brain cancer, with limited and expensive treatment options[2].

Impact on Patients and Clinical Trials

The withdrawal of Lomustine from Medicare coverage has severe implications for patients, particularly those with glioblastoma, a deadly brain cancer. It not only affects current treatment plans but also hampers clinical trials that rely on Lomustine as a control arm. This situation highlights the broader issue of pharmaceutical companies' control over drug pricing and its impact on patient care and medical research[2].

Patient Assistance Programs

To mitigate some of the financial burdens, NextSource Pharmaceuticals offers the NextSource Cares® patient assistance program. This program provides financial assistance to eligible patients, helping with claims processing, coverage verification, and appeals assistance for underpaid claims. However, this program is limited and does not address the broader issue of affordability for all patients[5].

Market Segments

The Lomustine market is segmented based on several factors:

  • Formulations: Oral capsules and injectable forms are the primary formulations available[1].
  • End-Use Settings: Hospitals, oncology clinics, research institutes, and home care settings are key segments[1].
  • Geographical Regions: North America, Europe, Asia Pacific, and other regions are analyzed for their market performance[1].

Financial Trajectory

The financial trajectory of the Lomustine market is marked by robust growth driven by increasing demand and advancements in healthcare. Here are some key financial highlights:

  • Revenue Growth: The market is expected to grow significantly over the forecast period, driven by the factors mentioned above[1].
  • CAGR: The market is projected to grow at a substantial CAGR from 2024 to 2034[1].
  • Market Size: By the end of the forecast period, the market is expected to reach a substantial value in USD million[1].

Challenges and Opportunities

Challenges

  • Price Gouging: The significant price increase by NextSource Pharmaceuticals poses a major challenge for patient access and affordability[2].
  • Single-Source Manufacturing: The monopoly held by NextSource in the U.S. market exacerbates pricing issues and limits patient options[2].

Opportunities

  • Emerging Markets: The growing healthcare infrastructure and increasing awareness about cancer treatments in emerging markets present significant opportunities for growth[1].
  • Combination Therapies: The role of Lomustine in combination therapies and targeted treatments offers opportunities for expanded use and market growth[1].

Key Takeaways

  • The global Lomustine market is driven by increasing cancer incidence and advancements in oncology.
  • North America dominates the market, followed by Europe and the rapidly growing Asia Pacific region.
  • Price gouging and single-source manufacturing pose significant challenges to patient access.
  • Patient assistance programs, though helpful, are limited in scope.
  • The market is expected to grow substantially over the forecast period.

FAQs

1. What is Lomustine used for?

Lomustine is used to treat various types of cancer, including brain tumors, melanoma, and lymphomas.

2. Why is the Lomustine market growing?

The market is growing due to increasing cancer incidence, advancements in oncology, and improvements in healthcare infrastructure.

3. Which region dominates the Lomustine market?

North America dominates the Lomustine market, holding more than 48% of the market share.

4. What are the challenges faced by patients due to NextSource Pharmaceuticals' actions?

Patients face challenges due to the significant price increase and the withdrawal of Lomustine from Medicare coverage, limiting their access to affordable treatment.

5. Are there any patient assistance programs available for Lomustine?

Yes, NextSource Pharmaceuticals offers the NextSource Cares® patient assistance program to provide financial assistance to eligible patients.

Cited Sources:

  1. We Market Research - Global Lomustine Market Size, Industry Insights, Future Trends[1]
  2. The Cancer Letter - Rogue drug maker first inflates the price of lomustine, then says No to Medicare[2]
  3. Market.us - Glioblastoma Multiforme Treatment Market Size | CAGR Of 8.1%[3]
  4. Market Research Intellect - Global Lomustine Market Size, Trends and Projections[4]
  5. NextSource Pharmaceuticals - NextSource Cares®: Patient Assistance Program - Gleostine[5]

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