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Last Updated: December 22, 2024

LEUKERAN Drug Patent Profile


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Which patents cover Leukeran, and when can generic versions of Leukeran launch?

Leukeran is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in LEUKERAN is chlorambucil. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorambucil profile page.

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Summary for LEUKERAN
Drug patent expirations by year for LEUKERAN
Drug Prices for LEUKERAN

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Recent Clinical Trials for LEUKERAN

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

SponsorPhase
TG Therapeutics, Inc.Phase 3
GlaxoSmithKlinePhase 3
University of LiverpoolPhase 3

See all LEUKERAN clinical trials

Pharmacology for LEUKERAN
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information for LEUKERAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Waylis Therap LEUKERAN chlorambucil TABLET;ORAL 010669-002 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

LEUKERAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Leukeran (Chlorambucil)

Introduction to Leukeran (Chlorambucil)

Leukeran, known generically as chlorambucil, is a medication used to treat various types of cancer, including chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), and Hodgkin's disease. It belongs to the class of alkylating agents and is administered orally[1].

Market Drivers

The market for Leukeran is driven by several key factors:

Growing Prevalence of Blood Cancers

The increasing incidence of blood cancers globally is a significant driver for the Leukeran market. As the population ages and the prevalence of these diseases rises, the demand for effective treatments like chlorambucil is expected to grow[1].

Government Initiatives and Awareness

Government initiatives aimed at preventing and treating cancer, along with growing public awareness about the importance of cancer treatment, are also driving the market. These efforts lead to increased funding and support for cancer research and treatment options, including Leukeran[1].

Advances in Healthcare

Advancements in healthcare, particularly in the fields of oncology and pharmacology, contribute to the market growth. Improved diagnostic techniques and targeted therapies enhance the effectiveness of treatments like Leukeran, making them more appealing to patients and healthcare providers[3].

Market Restraints

Despite the positive drivers, there are several restraints affecting the Leukeran market:

High Treatment Costs

One of the major restraints is the high cost associated with Leukeran treatment. The drug is only available as a brand-name medication, which makes it expensive due to the extensive research and testing required to ensure its safety and efficacy. A 25-tablet supply of 2 mg Leukeran tablets can cost around $6,959, depending on the pharmacy[5].

Lack of Generic Alternatives

The absence of generic versions of Leukeran further exacerbates the cost issue. Generic drugs typically cost less because they do not require the same level of research and testing as brand-name drugs. However, since Leukeran's patent has not yet expired, generic alternatives are not available[2][4].

Financial Trajectory

Current Market Size and Forecast

The Leukeran market is part of the broader cancer treatment market, which is experiencing significant growth. While specific financial projections for Leukeran alone are not detailed, the overall market for cancer treatments is robust. For instance, the chronic myeloid leukemia treatment market, which is related but distinct, is projected to grow to $12.06 billion by 2028 at a CAGR of 7.0%[3].

Cost Factors and Pricing

The cost of Leukeran varies based on several factors, including the patient's treatment plan, insurance coverage, and the pharmacy used. Without insurance, the cost can be prohibitively high, but with insurance, the out-of-pocket expenses can be significantly reduced. However, even with insurance, the cost remains substantial due to the brand-name status of the drug[2][4].

Financial Assistance and Savings Programs

To mitigate the high costs, various financial assistance programs and savings options are available. Patients can benefit from coupons, drug savings programs, and patient assistance plans. For example, getting a 90-day supply of Leukeran, if approved by the insurance company, can help reduce the number of pharmacy visits and lower the overall cost[2][4].

Regional Market Analysis

The Leukeran market is analyzed across several major regions, including North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA), and South & Central America. Each region has its own market dynamics influenced by local healthcare policies, economic conditions, and the prevalence of blood cancers.

Market Size and Forecast by Region

The market size and forecast vary by region, with North America and Europe typically being the largest markets due to their advanced healthcare systems and higher awareness about cancer treatments. The APAC region is also expected to show significant growth due to its large population and increasing healthcare spending[1].

Competitive Landscape

The Leukeran market involves several key players focusing on both organic and inorganic growth strategies. These strategies include product launches, product approvals, partnerships, and acquisitions. Companies in this market are anticipated to have lucrative growth opportunities as the demand for chlorambucil increases globally[1].

SWOT Analysis

Strengths

  • Effective treatment for CLL, NHL, and Hodgkin's disease.
  • Strong brand presence as Leukeran.
  • Growing demand due to increasing prevalence of blood cancers.

Weaknesses

  • High treatment costs.
  • Lack of generic alternatives.
  • Side effects such as bone marrow suppression.

Opportunities

  • Expanding into emerging markets.
  • Government initiatives and public awareness campaigns.
  • Advances in healthcare and diagnostic technologies.

Threats

  • Competition from other cancer treatments.
  • Regulatory challenges and patent expirations.
  • Economic factors affecting healthcare spending.

Key Takeaways

  • The Leukeran market is driven by the growing prevalence of blood cancers and government initiatives.
  • High treatment costs and the lack of generic alternatives are significant restraints.
  • The market is expected to grow, particularly in regions with advanced healthcare systems.
  • Financial assistance programs and savings options are crucial for making the treatment more accessible.
  • The competitive landscape is dynamic, with companies focusing on various growth strategies.

FAQs

What is Leukeran used for?

Leukeran (chlorambucil) is used to treat chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), and Hodgkin's disease.

Why is Leukeran so expensive?

Leukeran is expensive because it is a brand-name drug that has undergone extensive research and testing to ensure its safety and efficacy. Additionally, it does not yet have a generic alternative.

How can I reduce the cost of Leukeran?

You can reduce the cost of Leukeran by using financial assistance programs, drug savings programs, and by getting a 90-day supply if approved by your insurance company.

Is Leukeran available in generic form?

No, Leukeran is currently only available as a brand-name drug and does not have a generic version.

What are the common side effects of Leukeran?

Common side effects of Leukeran include bone marrow suppression, among others.

Sources

  1. The Insight Partners: Chlorambucil Market Developments by 2031.
  2. Healthline: Leukeran and Cost: Ways to Save and Cost Assistance.
  3. GlobeNewswire: Chronic Myeloid Leukemia Treatment Market On A Growth Trajectory.
  4. Medical News Today: Leukeran and cost: Reducing long-term drug costs and more.
  5. Drugs.com: Leukeran Prices, Coupons, Copay Cards & Patient Assistance.

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