CLOFARABINE - Generic Drug Details

What are the generic sources for clofarabine and what is the scope of freedom to operate?

Clofarabine is the generic ingredient in two branded drugs marketed by Abon Pharms Llc, Accord Hlthcare, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Hospira, Meitheal, MSN, Mylan Labs Ltd, Novast Labs, and Genzyme, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for clofarabine. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for CLOFARABINE

US Patents:	0
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	166
Patent Applications:	5,901
Drug Prices:	Drug price trends for CLOFARABINE
What excipients (inactive ingredients) are in CLOFARABINE?	CLOFARABINE excipients list
DailyMed Link:	CLOFARABINE at DailyMed

See drug prices for CLOFARABINE

Recent Clinical Trials for CLOFARABINE

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

Sponsor	Phase
John Horan, MD	Phase 1/Phase 2
GlycoMimetics Incorporated	Phase 1/Phase 2
Vastra Gotaland Region	Phase 3

See all CLOFARABINE clinical trials

Generic filers with tentative approvals for CLOFARABINE

Applicant	Application No.	Strength	Dosage Form
		20MG/20ML	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CLOFARABINE

Drug Class	Nucleoside Metabolic Inhibitor
Mechanism of Action	Nucleic Acid Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CLOFARABINE

L01BB	Purine analogues
L01B	ANTIMETABOLITES
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CLOFARABINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CLOLAR	Injection	clofarabine	1 mg/mL, 20 mL vial	021673	1	2012-02-23

US Patents and Regulatory Information for CLOFARABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	205375-001	Nov 6, 2017	AP	RX	No	No
Eugia Pharma	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	212457-001	Oct 3, 2022		DISCN	No	No
Abon Pharms Llc	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	204029-001	May 9, 2017	AP	RX	No	No
Hospira	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	210283-001	Dec 27, 2018		DISCN	No	No
Msn	CLOFARABINE	clofarabine	SOLUTION;INTRAVENOUS	209775-001	Dec 6, 2017	AP	RX	No	No
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	AP	RX	Yes	Yes

Expired US Patents for CLOFARABINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	4,918,179
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	5,661,136*PED
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	5,384,310

EU/EMA Drug Approvals for CLOFARABINE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ORPHELIA Pharma SAS	Ivozall	clofarabine	EMEA/H/C/005039 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.	Authorised	yes	no	no	2019-11-14
Sanofi B.V.	Evoltra	clofarabine	EMEA/H/C/000613 Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ≤ 21 years old at initial diagnosis.	Authorised	no	no	no	2006-05-29

CLOFARABINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clofarabine

Introduction to Clofarabine

Clofarabine is a chemotherapy drug used primarily in the treatment of various types of leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). It works by interfering with the growth of cancer cells, thereby inhibiting their proliferation.

Global Market Size and Growth

The global clofarabine market is anticipated to experience significant growth in the coming years. As of 2024, the market size is estimated to be USD XX million and is projected to expand at a compound annual growth rate (CAGR) of 6.60% from 2024 to 2031[1][4].

Regional Market Dynamics

North America

North America holds a substantial share of the global clofarabine market, accounting for more than 40% of the global revenue. The region's advanced healthcare infrastructure, well-equipped research and development facilities, and supportive regulatory frameworks contribute to this dominance. The market in North America is expected to grow at a CAGR of 4.8% from 2024 to 2031[1].

Asia-Pacific

The Asia-Pacific region is another key market for clofarabine, with a market share of around 23% of the global revenue. This region is expected to grow at a CAGR of 8.6% from 2024 to 2031, driven by increasing healthcare expenditure, heightened awareness of leukemia treatments, and enhanced accessibility to advanced therapies in countries like China and India[1].

Segmentation by End-Use

Hospital Segment

The hospital segment is the fastest-growing segment in the clofarabine market, driven by the increasing number of patient admissions and the preference for inpatient therapies for acute leukemia. Hospitals play a crucial role in providing advanced medical services and pioneering treatments, which contributes to the segment's growth[1].

Pharmacy Segment

The pharmacy segment is also experiencing significant growth, fueled by the increasing demand for outpatient therapies such as chemotherapy. The availability of clofarabine for home infusion has enhanced convenience for patients and caregivers, leading to a growing preference for accessible and patient-centric treatment options[1].

Drivers of Market Growth

Increasing Demand for Leukemia Treatments

The escalating demand for effective leukemia treatments is a major driver of the clofarabine market. The prevalence of leukemia and the need for advanced therapies are increasing globally, particularly in regions with growing healthcare infrastructure and awareness[1].

Advancements in Healthcare Infrastructure

The expansion of healthcare infrastructure, especially in the Asia-Pacific region, is another significant driver. Improved access to advanced medical facilities and treatments is boosting the demand for clofarabine and other chemotherapy drugs[1].

Supportive Regulatory Frameworks

Regulatory support and stringent healthcare standards, particularly in North America, are also driving the market growth. These frameworks ensure the safety and efficacy of drugs like clofarabine, enhancing their adoption in clinical settings[1].

Challenges and Constraints

Drug Shortages

Drug shortages can significantly impact the market dynamics of clofarabine. Shortages can arise due to disruptions in the supply chain, manufacturing issues, or sudden increases in demand. These shortages can affect patient access to the drug and impact market growth[3].

Economic Factors

The economic impact of drug shortages and the overall cost of treatment can also pose challenges. The financial burden on patients and healthcare systems can influence the demand for clofarabine and other chemotherapy drugs[3].

Clinical Trials and Research

Several clinical trials are ongoing to evaluate the efficacy and safety of clofarabine in combination with other drugs. For example, a randomized phase III trial is comparing clofarabine with daunorubicin hydrochloride and cytarabine in treating older patients with newly diagnosed AML. These trials aim to optimize treatment regimens and improve patient outcomes[2].

Financial Trajectory

The financial trajectory of the clofarabine market is promising, with steady growth anticipated over the next several years. Here are some key financial highlights:

• Market Size: The global clofarabine market size was estimated at USD XX million in 2024 and is expected to grow at a CAGR of 6.60% from 2024 to 2031[1][4].
• Revenue Growth: The market is expected to expand significantly, driven by the increasing demand for leukemia treatments and advancements in healthcare infrastructure[1].
• Regional Revenue: North America and the Asia-Pacific region are the major contributors to the global revenue, with North America holding over 40% and the Asia-Pacific region holding around 23% of the global market share[1].

Key Players and Competitors

The clofarabine market is competitive, with several key players involved in the development, manufacturing, and distribution of the drug. These players include pharmaceutical companies that are investing heavily in research and development to improve treatment outcomes and expand their market share[4].

Future Outlook

The future outlook for the clofarabine market is positive, driven by the increasing global demand for effective leukemia treatments and the ongoing advancements in healthcare infrastructure. However, the market will need to navigate challenges such as drug shortages and economic factors to sustain its growth trajectory.

Key Takeaways

• The global clofarabine market is expected to grow at a CAGR of 6.60% from 2024 to 2031.
• North America and the Asia-Pacific region are the major markets, driven by advanced healthcare infrastructure and increasing demand for leukemia treatments.
• The hospital and pharmacy segments are key drivers of market growth.
• Clinical trials are ongoing to optimize treatment regimens and improve patient outcomes.
• Drug shortages and economic factors are significant challenges that need to be addressed.

FAQs

Q: What is the primary use of clofarabine? A: Clofarabine is primarily used in the treatment of various types of leukemia, including acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL).

Q: What is the expected CAGR of the global clofarabine market from 2024 to 2031? A: The global clofarabine market is expected to grow at a CAGR of 6.60% from 2024 to 2031.

Q: Which regions are the major contributors to the global clofarabine market? A: North America and the Asia-Pacific region are the major contributors, with North America holding over 40% and the Asia-Pacific region holding around 23% of the global market share.

Q: What are the key drivers of the clofarabine market growth? A: The key drivers include increasing demand for leukemia treatments, advancements in healthcare infrastructure, and supportive regulatory frameworks.

Q: What challenges does the clofarabine market face? A: The market faces challenges such as drug shortages and economic factors that can impact patient access and market growth.

Cited Sources

1. Cognitive Market Research - Clofarabine Market Report 2024 (Global Edition)
2. Mayo Clinic Research - Leukemia Clinical Trials
3. ASPE - Impact of Drug Shortage on Cancer
4. Research and Markets - Clofarabine Market Size, Competitors & Forecast to 2030