CLOLAR Drug Patent Profile

Which patents cover Clolar, and when can generic versions of Clolar launch?

Clolar is a drug marketed by Genzyme and is included in one NDA.

The generic ingredient in CLOLAR is clofarabine. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the clofarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Clolar

A generic version of CLOLAR was approved as clofarabine by ABON PHARMS LLC on May 9^th, 2017.

Summary for CLOLAR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	66
Patent Applications:	4,294
Drug Prices:	Drug price information for CLOLAR
What excipients (inactive ingredients) are in CLOLAR?	CLOLAR excipients list
DailyMed Link:	CLOLAR at DailyMed

See drug prices for CLOLAR

Recent Clinical Trials for CLOLAR

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

Sponsor	Phase
John Horan, MD	Phase 1/Phase 2
GlycoMimetics Incorporated	Phase 1/Phase 2
Medexus Pharma, Inc.	Phase 2

See all CLOLAR clinical trials

Pharmacology for CLOLAR

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

Paragraph IV (Patent) Challenges for CLOLAR

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 CLOLAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	AP	RX	Yes	Yes

Expired US Patents for CLOLAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004

EU/EMA Drug Approvals for CLOLAR

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

International Patents for CLOLAR

See the table below for patents covering CLOLAR around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	122006000060
Germany	3687397
Canada	2102782	UTILISATION DE 2-FLUORO-ADENINYLARABINOSIDES SUBSTITUES EN 2DANS LE TRAITEMENT ANTICANCEREUX (2-FLUORO-2-SUBSTITUTED ADENINYL ARABINOSIDES AS ANTI-CANCER AGENTS)
Japan	3160288
World Intellectual Property Organization (WIPO)	9014352

Supplementary Protection Certificates for CLOLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0473708	06C0038	France		PRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529
0473708	SPC/GB06/040	United Kingdom		PRODUCT NAME: THE USE OF CLOFARABINE (2-CHLORO-9-(2-DEOXY-2-FLUORO-SS-D-ARABINOFURANOSYL)-ADENINE) FOR THE MANUFACTURE OF A MEDICAMENT FOR THE TREATMENT OF CANCER; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529
0219829	06C0029	France		PRODUCT NAME: CLOFARABINE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/334/001 DU 20060529; REGISTRATION NO/DATE AT EEC: EU/1/06/334/001 DU 20060529
0473708	300247	Netherlands		300247, 20100523, EXPIRES: 20150522
0219829	SPC/GB06/034	United Kingdom		PRODUCT NAME: CLOFARABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/06/334/001 20060529; UK EU/1/06/334/002 20060529; UK EU/1/06/334/003 20060529; UK EU/1/06/334/004 20060529

CLOLAR Market Analysis and Financial Projection Experimental

Clofarabine Market Dynamics and Financial Trajectory: A Comprehensive Overview

Market Size and Growth Rate

The global Clofarabine market is poised for significant growth, driven by several key factors. As of 2024, the market size was estimated at USD XX million and is expected to expand at a compound annual growth rate (CAGR) of 5.90% from 2024 to 2030[4].

Regional Market Breakdown

North America

North America holds a dominant position in the Clofarabine market, accounting for more than 40% of the global revenue. This region's advanced healthcare infrastructure, well-equipped research and development facilities, and supportive regulatory frameworks contribute to its leading role. The market in North America is projected to grow at a CAGR of 4.8% from 2024 to 2031[1].

Europe

Europe accounts for over 30% of the global Clofarabine market. The region's market is expected to grow at a CAGR of 5.1% from 2024 to 2031, driven by similar factors such as advanced healthcare systems and strong pharmaceutical sectors[1].

Asia-Pacific

The Asia-Pacific region holds around 23% of the global market share and is expected to grow at a CAGR of 8.6% from 2024 to 2031. This rapid growth is attributed to the expansion of the pharmaceutical sector, substantial patient demographics, and investments in healthcare infrastructure[1].

Market Drivers

Rising Adoption of Combination Therapies

The increasing adoption of combination therapies involving Clofarabine is a significant driver. These therapies have shown improved patient outcomes, leading to higher demand for Clofarabine[4].

Expansion of Healthcare Infrastructure

Emerging economies are investing heavily in healthcare infrastructure, which is boosting the market growth. Advanced facilities and better access to healthcare services are increasing the demand for Clofarabine[4].

Increasing Awareness and Early Diagnosis

Global awareness and early diagnosis rates of pediatric cancers are on the rise, contributing to the growing demand for Clofarabine. This trend is particularly notable in regions with improving healthcare standards[4].

Strategic Collaborations

Key players in the market are engaging in strategic collaborations and partnerships to enhance their market presence. These collaborations often lead to better distribution networks and increased market penetration[4].

Market Restraints

Limited Patient Population

The market size is constrained by the limited patient population for rare diseases such as acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML)[4].

Competition from Alternative Therapies

Competition from alternative therapies and generic drugs impacts the market share of Clofarabine. Other treatments, such as CAR T-cell therapies, are gaining traction and may divert some of the demand away from Clofarabine[3][4].

Market Opportunities

Collaborations with Healthcare Institutions

Collaborations with healthcare institutions can boost awareness and adoption of Clofarabine in clinical practices. Such partnerships can lead to better integration of Clofarabine into treatment protocols[4].

Expansion of Indications

Expanding the indications for Clofarabine to include more hematologic malignancies can significantly amplify market growth. Research into its potential use in other types of leukemia, such as acute myeloid leukemia (AML) and juvenile myelomonocytic leukemia (JMML), is ongoing[5].

Advanced Drug Delivery Systems

Leveraging advanced drug delivery systems can improve the efficacy of Clofarabine and reduce its side effects. Innovations in drug delivery could enhance patient outcomes and increase the drug's market appeal[4].

Market Challenges

Continuous Clinical Trials

The necessity for continuous clinical trials and studies for Clofarabine impacts overall market expenditure. These trials are essential for ensuring the drug's safety and efficacy but add to the costs associated with its development and maintenance[4].

Global Distribution and Logistics

Challenges in global distribution and logistics due to varying international trade regulations can hinder the market growth. Ensuring compliance with different regulatory frameworks is crucial for smooth market operations[4].

Financial Performance and Projections

The Clofarabine market has shown steady financial growth. From USD 456.00 million in 2023, the market grew to USD 489.45 million in 2024 and is projected to continue growing at a CAGR of 5.90% until 2030[4].

Key Players and Market Share

Key players such as Genzyme Corp and other manufacturers are driving the market forward through strategic acquisitions and partnerships. For instance, Eagle Pharmaceuticals' acquisition of Acacia Pharma Group plc in June 2022 expanded its reach in the acute care sector[1].

Revenue by Therapeutic Indications

The market revenue is segmented by therapeutic indications, with a significant portion coming from the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML). The market size by these indications is expected to grow substantially over the forecast period[4].

Side Effects and Safety Considerations

Clofarabine, marketed as Clolar, has several side effects that need careful monitoring. These include cytokine release syndrome, severe and fatal hepatotoxicity, and renal toxicity. Close monitoring and early intervention are crucial to mitigate these risks[2].

Pharmacoeconomics

The cost-effectiveness of Clofarabine is a critical factor in its market dynamics. While it is more expensive than some standard therapies, it offers significant health gains. For example, in comparisons with CAR T-cell therapies, Clofarabine has shown to be a viable option in terms of cost-effectiveness, especially in pediatric and young adult patients with B-cell ALL[3].

Key Takeaways

• The global Clofarabine market is expected to grow at a CAGR of 5.90% from 2024 to 2030.
• North America, Europe, and the Asia-Pacific region are the key markets, driven by advanced healthcare infrastructure and increasing demand.
• Combination therapies, healthcare infrastructure expansion, and early diagnosis rates are significant market drivers.
• Limited patient population and competition from alternative therapies are market restraints.
• Collaborations with healthcare institutions and expanding indications offer market opportunities.
• Continuous clinical trials and global distribution challenges are key market challenges.

FAQs

What is Clofarabine used for?

Clofarabine is a purine nucleoside used to treat relapsed or refractory acute lymphoblastic leukemia (ALL) in patients 1 to 21 years old[5].

What are the major side effects of Clofarabine?

Major side effects include cytokine release syndrome, severe and fatal hepatotoxicity, and renal toxicity. Close monitoring is necessary to mitigate these risks[2].

Which regions dominate the Clofarabine market?

North America, Europe, and the Asia-Pacific region are the dominant markets for Clofarabine, driven by their advanced healthcare infrastructures and increasing demand[1].

What are the key drivers of the Clofarabine market?

Key drivers include the rising adoption of combination therapies, expansion of healthcare infrastructure in emerging economies, and increasing awareness and early diagnosis rates of pediatric cancers[4].

How does Clofarabine compare to CAR T-cell therapies in terms of cost-effectiveness?

Clofarabine is more expensive than some standard therapies but offers significant health gains. It compares favorably to CAR T-cell therapies in terms of cost-effectiveness, especially in pediatric and young adult patients with B-cell ALL[3].

Sources

1. Cognitive Market Research: Clofarabine Market Report 2024 (Global Edition)
2. Sanofi U.S.: CLOLAR® (clofarabine) injection, for intravenous use
3. The American Journal of Managed Care: Improving Outcomes and Mitigating Costs Associated With CAR T-cell Therapy
4. Research and Markets: Clofarabine Market Size, Competitors & Forecast to 2030
5. DrugBank: Clofarabine: Uses, Interactions, Mechanism of Action