Busulfan - Generic Drug Details

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

Busulfan is the generic ingredient in three branded drugs marketed by Accord Hlthcare Inc, Actavis, Am Regent, Amneal, Apotex, Arthur Grp, Eugia Pharma, Hospira, Meitheal, Mylan Institutional, Nexus, Norvium Bioscience, Pharmascience Inc, Prinston Inc, Shilpa, Otsuka Pharm, and Waylis Therap, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for busulfan. Eleven suppliers are listed for this compound.

Summary for busulfan

US Patents:	0
Tradenames:	3
Applicants:	17
NDAs:	17
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	597
Patent Applications:	4,881
Drug Prices:	Drug price trends for busulfan
What excipients (inactive ingredients) are in busulfan?	busulfan excipients list
DailyMed Link:	busulfan at DailyMed

See drug prices for busulfan

Recent Clinical Trials for busulfan

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

Sponsor	Phase
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Washington University School of Medicine	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2

See all busulfan clinical trials

Pharmacology for busulfan

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for busulfan

Alkylating Agents

Antineoplastic Agents, Alkylating

Immunosuppressive Agents

Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for busulfan

L01AB	Alkyl sulfonates
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for BUSULFAN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BUSULFEX	Injection	busulfan	6 mg/mL	020954	1	2012-12-26

US Patents and Regulatory Information for busulfan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	BUSULFAN	busulfan	INJECTABLE;INJECTION	205672-001	Jul 31, 2018	AP	RX	No	No
Pharmascience Inc	BUSULFAN	busulfan	INJECTABLE;INJECTION	207050-001	Mar 24, 2017	AP	RX	No	No
Nexus	BUSULFAN	busulfan	INJECTABLE;INJECTION	207794-001	Jan 14, 2019		DISCN	No	No
Mylan Institutional	BUSULFAN	busulfan	INJECTABLE;INJECTION	208536-001	Nov 20, 2017	AP	RX	No	No
Accord Hlthcare Inc	BUSULFAN	busulfan	INJECTABLE;INJECTION	210148-001	Feb 22, 2019	AP	RX	No	No
Meitheal	BUSULFAN	busulfan	INJECTABLE;INJECTION	212127-001	Oct 23, 2020	AP	RX	No	No
Prinston Inc	BUSULFAN	busulfan	INJECTABLE;INJECTION	215235-001	Sep 11, 2024	AP	RX	No	No

Expired US Patents for busulfan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999	5,430,057*PED
Otsuka Pharm	BUSULFEX	busulfan	INJECTABLE;INJECTION	020954-001	Feb 4, 1999	5,559,148*PED

EU/EMA Drug Approvals for busulfan

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

Market Dynamics and Financial Trajectory of Busulfan

Introduction

Busulfan is a chemotherapeutic agent used primarily in the treatment of chronic myeloid leukemia and as a conditioning regimen for hematopoietic stem cell transplantation. Understanding the market dynamics and financial trajectory of busulfan is crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Segmentation

The busulfan market is segmented based on type, application, and geography.

Type of Busulfan

The market includes different types of busulfan, such as oral and intravenous (IV) formulations. IV busulfan has gained prominence due to its more predictable bioavailability and reduced toxicity compared to oral busulfan[2][5].

Applications of Busulfan

Busulfan is used in various therapeutic applications, including:

• Chronic Myeloid Leukemia (CML): As a primary treatment option.
• Myelodysplastic Syndromes (MDS): As part of conditioning regimens for stem cell transplantation.
• Acute Myeloid Leukemia (AML): In combination with other drugs for conditioning before transplantation[2].

Geographical Analysis

The busulfan market is analyzed across major regions including North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Each region has its own market size, revenue share, and growth trends. The report provides detailed insights into the revenue share and current trends at the country level as well as key regions[1][4].

Market Size and Growth Rate

The global busulfan market size was valued at a significant amount in 2023, with a projected compound annual growth rate (CAGR) from 2024 to 2031. The market is expected to grow driven by increasing demand for effective conditioning regimens in hematopoietic stem cell transplantation and the rising incidence of hematological malignancies[1][4].

Competitor Analysis

The busulfan market is characterized by several key players, each with their own market share and competitive strategies. The report includes a detailed competitor analysis, highlighting the strengths, weaknesses, and market positioning of each player. This analysis helps in understanding the competitive landscape and potential market opportunities[1][4].

Drivers and Opportunities

Several factors drive the growth of the busulfan market:

• Increasing Incidence of Hematological Malignancies: Rising cases of leukemia and other blood cancers increase the demand for busulfan.
• Advancements in Conditioning Regimens: Pharmacokinetic targeting of IV busulfan has reduced regimen-related toxicity, making it a preferred option[2][5].
• Growing Demand for Stem Cell Transplantation: The increasing number of stem cell transplants globally boosts the demand for busulfan.

Restraints and Challenges

Despite the growth potential, the busulfan market faces several challenges:

• Regulatory Scrutiny: Increased FDA scrutiny of generic drug applications can raise the cost of obtaining approval, potentially affecting market entry and competition[3].
• Toxicity and Side Effects: Busulfan is associated with significant side effects, including mucositis and hepatic veno-occlusive disease, which can impact its adoption[2].

Financial Trajectory

The financial trajectory of the busulfan market is influenced by several factors:

• Revenue Growth: The market is expected to see significant revenue growth driven by increasing demand and expanding applications.
• Generic Competition: The entry of generic versions of busulfan can lead to price reductions and increased competition, affecting the market dynamics. Generic drug prices typically fall with the number of competitors, approaching long-run marginal costs when there are 8 or more competitors[3].
• Cost of Production and Distribution: The cost of producing and distributing busulfan, especially the IV formulation, can impact the profitability of pharmaceutical companies.

Regional Market Insights

• North America: This region is expected to hold a significant market share due to advanced healthcare infrastructure and high adoption rates of new therapies.
• Europe: Europe is another key market with a strong presence of pharmaceutical companies and a high demand for busulfan.
• Asia Pacific: This region is expected to show rapid growth due to increasing healthcare spending and a rising incidence of hematological malignancies[1][4].

Technological Trends

Advancements in pharmacokinetic targeting and the development of IV busulfan have significantly improved the therapeutic outcomes and reduced toxicity. These technological trends are expected to continue shaping the market by enhancing the efficacy and safety of busulfan regimens[2][5].

SWOT Analysis

A SWOT analysis provides a comprehensive view of the busulfan market:

• Strengths: Effective in treating hematological malignancies, growing demand for stem cell transplantation.
• Weaknesses: Associated toxicity, regulatory challenges.
• Opportunities: Expanding applications, advancements in conditioning regimens.
• Threats: Generic competition, side effects.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the busulfan market. While it disrupted supply chains and delayed some clinical trials, the increased focus on healthcare and the need for effective treatments for critical conditions have also driven demand for essential medications like busulfan[1].

Key Takeaways

• The busulfan market is driven by increasing demand for effective conditioning regimens and the rising incidence of hematological malignancies.
• IV busulfan is gaining prominence due to its predictable bioavailability and reduced toxicity.
• Generic competition and regulatory scrutiny are key challenges.
• The market is expected to grow significantly across various regions, with North America and Europe holding significant market shares.

FAQs

1. What are the primary applications of busulfan?

   • Busulfan is primarily used in the treatment of chronic myeloid leukemia and as a conditioning regimen for hematopoietic stem cell transplantation.

2. What is the difference between oral and IV busulfan?

   • IV busulfan has more predictable bioavailability and reduced toxicity compared to oral busulfan, making it a preferred option in many cases.

3. How does generic competition affect the busulfan market?

   • Generic competition can lead to price reductions and increased market competition, affecting the profitability of pharmaceutical companies.

4. What are the key drivers of the busulfan market?

   • Increasing incidence of hematological malignancies, advancements in conditioning regimens, and growing demand for stem cell transplantation are key drivers.

5. How has the COVID-19 pandemic impacted the busulfan market?

   • The pandemic has had a mixed impact, disrupting supply chains but also driving demand for essential medications like busulfan.

Cited Sources:

1. Cognitivemarketresearch.com - Busulfan Market Report 2024 (Global Edition)
2. BMT CTN - BMT CLINICAL TRIALS NETWORK RIC vs. MAC – Protocol # 0901 Version 5.0
3. Federal Trade Commission - Generic Drug Industry Dynamics
4. Newschannelnebraska.com - Busulfan Market Size 2024 by Top Key Players, Product Types, Growth Rate, Applications, and Forecast till 2031
5. NCBI - Pharmacokinetic targeting of intravenous busulfan reduces conditioning regimen toxicity in patients undergoing hematopoietic cell transplantation.