MYLERAN Drug Patent Profile

When do Myleran patents expire, and what generic alternatives are available?

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

The generic ingredient in MYLERAN is busulfan. There are ten drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the busulfan profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Myleran

A generic version of MYLERAN was approved as busulfan by PHARMASCIENCE INC on March 24^th, 2017.

Summary for MYLERAN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	93
Patent Applications:	4,688
Drug Prices:	Drug price information for MYLERAN
What excipients (inactive ingredients) are in MYLERAN?	MYLERAN excipients list
DailyMed Link:	MYLERAN at DailyMed

See drug prices for MYLERAN

Recent Clinical Trials for MYLERAN

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

Sponsor	Phase
GlycoMimetics Incorporated	Phase 1/Phase 2
John Horan, MD	Phase 1/Phase 2
Jazz Pharmaceuticals	Phase 1/Phase 2

See all MYLERAN clinical trials

Pharmacology for MYLERAN

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for MYLERAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	MYLERAN	busulfan	TABLET;ORAL	009386-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

EU/EMA Drug Approvals for MYLERAN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pierre Fabre Medicament	Busilvex	busulfan	EMEA/H/C/000472 Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busilvex following fludarabine (FB) is indicated as conditioning treatment prior to haematopoietic progenitor cell transplantation (HPCT) in adult patients who are candidates for a reduced-intensity conditioning (RIC) regimen.Busilvex followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.	Withdrawn	no	no	no	2003-07-09
Fresenius Kabi Deutschland GmbH	Busulfan Fresenius Kabi	busulfan	EMEA/H/C/002806 Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy2) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation (HPCT) in adult patients when the combination is considered the best available option.Busulfan Fresenius Kabi followed by cyclophosphamide (BuCy4) or melphalan (BuMel) is indicated as conditioning treatment prior to conventional haematopoietic progenitor cell transplantation in paediatric patients.	Authorised	yes	no	no	2014-09-22

MYLERAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for MYLERAN (Busulfan)

Introduction

MYLERAN, also known as busulfan, is a potent bifunctional alkylating agent used primarily for the palliative treatment of chronic myelogenous leukemia (CML) and other hematological disorders. Here, we will delve into the market dynamics and financial trajectory of this critical medication.

Therapeutic Indications and Usage

MYLERAN is specifically indicated for the treatment of chronic myelogenous leukemia, a type of blood cancer. It is effective in producing prolonged remission in patients with CML and is also used in the management of polycythaemia vera, particularly in cases with marked thrombocytosis[1][2][4].

Market Position

Competitive Landscape

The market for CML treatments is competitive, with various drugs and therapies available. However, MYLERAN remains a significant player due to its long history of use and established efficacy. The drug's market position is reinforced by its inclusion in treatment protocols for specific patient populations where other treatments may not be as effective or suitable.

Patient Population

The patient population for MYLERAN includes those diagnosed with CML and other related hematological conditions. The demand for this drug is steady, driven by the need for effective treatments in these patient groups. The incidence of CML, although relatively rare, ensures a consistent market for MYLERAN[2][4].

Financial Performance

Revenue and Growth

While specific financial data for MYLERAN alone is not readily available, the overall market for cancer treatments, including CML therapies, is substantial. Companies involved in the distribution and marketing of MYLERAN, such as Medexus, report significant revenues from their oncology portfolios. For instance, Medexus reported $113.1 million in revenue for FY2024, with a notable portion attributed to their oncology products, although the exact figure for MYLERAN is not specified[3].

Cost and Pricing

The cost of MYLERAN can vary based on the region, healthcare system, and insurance coverage. However, it is generally considered a high-cost medication due to its specialized use and the complexity of its administration. The pricing strategy often involves negotiations with healthcare providers and payers to ensure accessibility while maintaining profitability.

Regulatory Environment

Approvals and Compliance

MYLERAN has been approved for use in various countries, including the United States and New Zealand. The drug is subject to stringent regulatory oversight due to its potent nature and potential side effects. Compliance with regulatory requirements is crucial for maintaining market approval and ensuring patient safety[1][2].

Comparative Therapies

The regulatory environment also influences the market dynamics through the approval of comparative therapies. For example, treosulfan, another alkylating agent, is under review by the FDA and has shown promising results in clinical trials, potentially impacting the market share of MYLERAN in the future[3].

Side Effects and Safety Concerns

Impact on Market Dynamics

The safety profile of MYLERAN, including its potential for severe bone marrow hypoplasia, pulmonary fibrosis, and leukaemogenic effects, can influence market dynamics. These side effects necessitate careful patient monitoring and may limit the drug's use in certain patient populations, affecting its overall market penetration[1][2].

Market Trends and Forecast

Growing Demand for Cancer Treatments

The global demand for cancer treatments is increasing, driven by rising cancer incidence rates and advancements in healthcare. This trend is expected to benefit drugs like MYLERAN, although the market will remain competitive with the introduction of new therapies.

Generic and Biosimilar Competition

The potential for generic or biosimilar versions of MYLERAN could impact its market share and pricing. However, the complexity of manufacturing and the regulatory hurdles involved in approving generics or biosimilars for such a potent drug may delay this competition.

Key Players and Distribution

Medexus and Other Distributors

Companies like Medexus play a significant role in the distribution and marketing of MYLERAN. Medexus has a strong commercial platform in North America, which helps in maintaining the drug's market presence. Their focus on innovative pharmaceutical products and established sales infrastructure supports the continued availability and promotion of MYLERAN[3].

Conclusion

MYLERAN remains a critical component in the treatment of chronic myelogenous leukemia and other hematological disorders. Its market dynamics are influenced by its established efficacy, regulatory environment, and the presence of potential comparative therapies. The financial trajectory of MYLERAN is tied to the broader oncology market trends, with steady demand driven by the need for effective treatments in specific patient populations.

Key Takeaways

• Therapeutic Indications: MYLERAN is primarily used for the palliative treatment of chronic myelogenous leukemia and polycythaemia vera.
• Market Position: The drug holds a significant position in the CML treatment market due to its long history and efficacy.
• Financial Performance: Part of the revenue generated by companies like Medexus from their oncology portfolios.
• Regulatory Environment: Subject to stringent regulatory oversight due to its potent nature and potential side effects.
• Safety Concerns: Severe side effects such as bone marrow hypoplasia and pulmonary fibrosis impact its market dynamics.
• Market Trends: Growing demand for cancer treatments and potential competition from new therapies.

FAQs

What is MYLERAN used for?

MYLERAN (busulfan) is used for the palliative treatment of chronic myelogenous leukemia (CML) and other related hematological conditions like polycythaemia vera.

What are the potential side effects of MYLERAN?

MYLERAN can cause severe bone marrow hypoplasia, pulmonary fibrosis, and has leukaemogenic effects. It also may lead to other serious side effects such as pancytopenia and cellular dysplasia in various organs.

How is MYLERAN administered?

MYLERAN is available in tablet form for oral administration. The dose is typically adjusted based on the patient's response and must be monitored closely to avoid adverse effects.

What companies are involved in the distribution of MYLERAN?

Companies like Medexus are involved in the distribution and marketing of MYLERAN, particularly in North America.

Is MYLERAN still widely used despite the availability of newer treatments?

Yes, MYLERAN remains a significant treatment option for CML due to its established efficacy and long history of use, despite the introduction of newer therapies.

Sources

1. Medsafe: MYLERAN tablets datasheet.
2. FDA: MYLERAN (busulfan) prescribing information.
3. Medexus: Market and industry data presentation.
4. RxList: Myleran (busulfan) drug information.