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Last Updated: December 28, 2024

MUSTARGEN Drug Patent Profile


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Which patents cover Mustargen, and what generic alternatives are available?

Mustargen is a drug marketed by Recordati Rare and is included in one NDA.

The generic ingredient in MUSTARGEN is mechlorethamine hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the mechlorethamine hydrochloride profile page.

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Drug patent expirations by year for MUSTARGEN
Drug Prices for MUSTARGEN

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Recent Clinical Trials for MUSTARGEN

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SponsorPhase
Eastern Cooperative Oncology GroupPhase 3
National Cancer Institute (NCI)Phase 3

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US Patents and Regulatory Information for MUSTARGEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Recordati Rare MUSTARGEN mechlorethamine hydrochloride INJECTABLE;INJECTION 006695-001 Approved Prior to Jan 1, 1982 DISCN Yes 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

MUSTARGEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MUSTARGEN

Overview of MUSTARGEN

MUSTARGEN, also known as mechlorethamine or HN2 hydrochloride, is a highly toxic anticancer chemotherapeutic drug used primarily in the treatment of various types of cancer, including lymphomas and other neoplasms. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Context: Oncology Drugs

Global Oncology Drugs Market

The global oncology drugs market is experiencing rapid growth, driven by increasing cancer prevalence and the demand for innovative treatment options. The market was valued at $231.56 billion in 2024 and is projected to reach $532.91 billion by 2031, growing at a CAGR of 12.6% during the forecast period[3].

Segment Dominance

In the oncology drugs market, the cytotoxic drugs segment, which includes MUSTARGEN, currently holds a significant share due to the widespread adoption of chemotherapy regimens. However, targeted therapies and immunotherapies are expected to gain prominence and potentially surpass cytotoxic drugs by 2031[3].

Pricing and Cost Factors

Pricing of MUSTARGEN

The pricing of MUSTARGEN is influenced by several factors, including production costs, market demand, and regulatory environments. As of recent data, a 10 mg vial of MUSTARGEN costs approximately $178.71 USD[4].

Cost Implications for Patients and Healthcare Systems

Given its toxicity and the need for careful administration, the use of MUSTARGEN can be costly not only due to the drug itself but also due to the required medical supervision and potential side effects management. This can lead to significant financial burdens on patients and healthcare systems, especially in cases where multiple treatments are necessary[2][5].

Patent Protection and Market Exclusivity

Impact on Competition

MUSTARGEN, like many other brand-name drugs, benefits from patent protection and market exclusivity. These protections allow the drug manufacturer to recoup research and development costs and earn a return on investment. However, once these protections expire, the market may open up to generic competitors, potentially reducing the drug's market share and revenue[1].

Current Patent Status

As of the latest available data, MUSTARGEN has several patents that are set to expire in the mid to late 2020s. For example, patents such as US7872050, US8501819, and US9382191 are estimated to expire around 2026-2029[4].

Market Dynamics and Competition

Consolidation in the Pharmaceutical Industry

The pharmaceutical industry, including the oncology segment, has seen significant consolidation through mergers and acquisitions. This trend can lead to fewer companies producing and marketing drugs, resulting in greater market domination by certain companies and reduced competition. For instance, large pharmaceutical companies have acquired smaller ones that specialize in niche markets, including those targeting specific cancer types[1].

Key Players in the Oncology Market

Major players in the oncology drugs market include Hoffmann-La Roche Ltd., Genentech, Inc., Novartis AG, Gilead Sciences Inc., AstraZeneca, and others. These companies often have a diverse portfolio of oncology drugs, including both cytotoxic agents like MUSTARGEN and newer targeted therapies[3].

Regulatory Environment

Stringent Regulations

The development and marketing of oncology drugs, including MUSTARGEN, are subject to stringent regulatory requirements. These regulations can impact the financial trajectory of the drug by affecting approval timelines, safety monitoring, and post-marketing surveillance. Compliance with these regulations is crucial for maintaining market presence[3].

Financial Projections

Revenue Forecast

While specific financial projections for MUSTARGEN alone are not readily available, the overall oncology drugs market is expected to grow significantly. The cytotoxic drugs segment, which includes MUSTARGEN, will likely continue to contribute substantially to this growth, although its share may decrease as targeted therapies gain more prominence[3].

Regional Market Growth

The oncology drugs market is expected to see significant growth in regions such as North America, Europe, and the Asia Pacific. The Asia Pacific region, in particular, is anticipated to witness the highest growth due to developing healthcare infrastructure, rising disposable incomes, and a growing patient population in countries like China and India[3].

Challenges and Opportunities

Side Effects and Toxicity

MUSTARGEN's high toxicity and potential for severe side effects, such as bone marrow suppression and reproductive issues, present significant challenges. These factors can affect patient compliance and overall market demand. However, advancements in drug delivery systems and the development of less toxic alternatives may offer opportunities for growth in the broader oncology market[2][5].

Innovation and Targeted Therapies

The increasing adoption of targeted therapies and immunotherapies offers a significant opportunity for growth in the oncology market. While MUSTARGEN may face competition from these newer treatments, the overall market expansion driven by these innovations can still benefit the drug's revenue to some extent[3].

Key Takeaways

  • Market Growth: The global oncology drugs market is projected to grow significantly, driven by increasing cancer prevalence and demand for innovative treatments.
  • Pricing and Costs: MUSTARGEN's pricing is influenced by production costs, market demand, and regulatory environments, and its use can be costly due to required medical supervision and potential side effects.
  • Patent Protection: Patent protection and market exclusivity play a crucial role in the financial trajectory of MUSTARGEN, but these protections are set to expire in the mid to late 2020s.
  • Regulatory Environment: Stringent regulations impact the development, approval, and marketing of oncology drugs.
  • Regional Growth: The Asia Pacific region is expected to witness the highest growth in the oncology drugs market.

FAQs

What is MUSTARGEN used for?

MUSTARGEN is used primarily in the treatment of various types of cancer, including lymphomas and other neoplasms.

How much does a vial of MUSTARGEN cost?

As of recent data, a 10 mg vial of MUSTARGEN costs approximately $178.71 USD.

What are the potential side effects of MUSTARGEN?

MUSTARGEN can cause severe side effects, including bone marrow suppression, leukopenia, thrombocytopenia, anemia, and reproductive issues.

How does patent protection affect MUSTARGEN's market presence?

Patent protection allows the manufacturer to recoup research and development costs and earn a return on investment, but once these protections expire, the market may open up to generic competitors.

What is the projected growth rate of the global oncology drugs market?

The global oncology drugs market is projected to grow at a CAGR of 12.6% from 2024 to 2031.

Which region is expected to see the highest growth in the oncology drugs market?

The Asia Pacific region is anticipated to witness the highest growth due to developing healthcare infrastructure, rising disposable incomes, and a growing patient population.

Sources

  1. GAO-10-201 Brand-Name Prescription Drug Pricing - U.S. Government Accountability Office[1]
  2. Mustargen: Package Insert / Prescribing Information - Drugs.com[2]
  3. Oncology Drugs Market to Reach USD 532.91 Billion by 2031 - Coherent Market Insights[3]
  4. Mechlorethamine: Uses, Interactions, Mechanism of Action - DrugBank[4]
  5. MUSTARGEN® - FDA Label[5]

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