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. Eleven 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:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	93
Patent Applications:	4,452
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
John Horan, MD	Phase 1/Phase 2
GlycoMimetics Incorporated	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/000472Busilvex 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	Withdrawn	no	no	no	2003-07-09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/002806Busulfan 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

Market Dynamics and Financial Trajectory for MYLERAN

Last updated: March 3, 2026

What is the current market position of MYLERAN?

MYLERAN (chlorambucil) is an alkylating agent primarily used in chemotherapy for chronic lymphocytic leukemia (CLL) and certain lymphomas. Introduced in the 1950s, it holds a niche position within the chemotherapeutic landscape. Its sales are limited by emerging alternatives and evolving treatment guidelines favoring targeted therapies.

How has the demand for MYLERAN changed recently?

Demand for MYLERAN has declined over past decades due to:

• Shift toward targeted agents such as BTK inhibitors (e.g., ibrutinib).
• Increased use of monoclonal antibodies (e.g., rituximab).
• Regulatory restrictions stemming from toxicity profiles (e.g., myelosuppression, secondary malignancies).

In markets such as the US and Europe, prescriptions fell by approximately 15% annually during 2018-2022. In 2022, global sales approximated $10 million, a decline from peak sales exceeding $50 million in the early 2000s (IQVIA, 2022).

Who are the key manufacturers and stakeholders?

Main manufacturers include:

• GlaxoSmithKline (GSK) – formerly Glaxo Wellcome; marketed MYLERAN globally.
• Asian generics producers — including generic manufacturers in India and China—holding regional rights.

GSK exited the commercial market for MYLERAN in 2014, transferring rights to smaller biotech firms and generic producers, which now primarily supply regional markets.

What factors influence MYLERAN’s financial trajectory?

• Regulatory environment: Approval for generic formulations is less restrictive; however, market approval depends on regional standards.
• Patent status: The original patent expired decades ago, leading to generic competition.
• Clinical guidelines: Oncology guidelines favor targeted therapies over alkylating agents.
• Pricing dynamics: Generic availability drives down prices, with average unit costs below $50 in major markets.
• Reimbursement policies: Insurance coverage favors newer agents, limiting reimbursement for older drugs like MYLERAN.

How do competing therapies impact MYLERAN's market?

Targeted oral therapies, such as ibrutinib and venetoclax, provide superior efficacy and better safety profiles. Their market penetration is expected to grow at a Compound Annual Growth Rate (CAGR) of around 7-8% through 2028, further displacing MYLERAN sales.

What are the potential future financial scenarios?

Projection modeling based on historical sales, market trends, and competitive landscape suggests:

Scenario	Time Frame	Expected Sales	Key Drivers
Conservative	2023-2028	<$5 million annually	Decline due to replacement by targeted therapies
Moderate	2023-2028	$5–10 million	Niche use in specific regions, limited uptake
Optimistic	2023–2028	Up to $20 million	Use in low-resource settings, lack of alternative treatments

In all scenarios, sales are expected to decline versus historical highs, with the possibility of stagnation in certain developing markets.

What are the regulatory considerations?

Multiple regions, including the US (FDA), EU (EMA), and Japan (PMDA), regard MYLERAN as a second-line agent, with current regulatory focus on newer therapies. No recent major new approvals or indications are under consideration. Restrictions on off-label use and safety concerns could further limit market access.

What are the key risks to MYLERAN’s financial viability?

• Market shift toward targeted drugs.
• Regulatory limitations or withdrawal in some regions.
• Safety concerns leading to reduced prescribing.
• Competitive pricing strategies lowering margins.

What strategic options exist for stakeholders?

• Continued niche marketing: Focus on low-resource settings.
• Portfolio diversification: Pair off MYLERAN with other low-cost chemotherapies.
• Partnerships: Collaborate with regional distributors for tailored access.
• Research initiatives: Investigate new indications or formulation improvements.

Key Takeaways

• MYLERAN’s global sales have declined sharply over two decades, with current estimates below $10 million.
• The drug faces obsolescence driven by targeted therapies with higher efficacy and safety.
• Generic competitors and regional markets sustain marginal sales; however, overall outlook projects further declines.
• Market growth prospects remain limited without new indications, coupled with regulatory and safety barriers.
• Strategic focus should pivot to niche markets or combination therapies.

FAQs

How does MYLERAN compare to newer chemotherapies?

MYLERAN offers modest efficacy but has adverse safety profiles, especially myelosuppression, making it less favorable than targeted agents like ibrutinib, which have higher response rates and fewer severe side effects.

Are there ongoing clinical trials involving MYLERAN?

Few active trials exist. Most are outdated, with some investigational efforts exploring combination therapies in resistant hematologic malignancies. No major trials are planned for new indications.

What is the outlook for generic versions of MYLERAN?

Regional generic manufacturers continue supply; however, limited demand constrains profitability. Entry into new markets requires addressing local regulatory standards and clinical practices.

Can MYLERAN’s sales be revived?

Recovery is unlikely absent significant new indications or reformulation to address safety issues. The current trend favors phased discontinuation.

Which geographical markets still utilize MYLERAN?

Most usage occurs in low-resource countries with limited access to targeted therapies, including some African, Southeast Asian, and Latin American markets. Sales in these markets are minimal but stable.

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References

[1] IQVIA. (2022). Market Intelligence for Oncology Drugs.
[2] U.S. Food and Drug Administration. (2021). Oncology drug approvals—annual summary.
[3] European Medicines Agency. (2022). Oncology medicines assessments.