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. Nine 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 AMNEAL on November 6^th, 2017.

Summary for CLOLAR

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	66
Patent Applications:	2,342
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
GlycoMimetics Incorporated	Phase 1/Phase 2
John Horan, MD	Phase 1/Phase 2
Medexus Pharma, Inc.	Phase 2

See all CLOLAR clinical trials

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		DISCN	Yes	No

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/005039Treatment 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/000613Treatment 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	69029733
Japan	3160288
Canada	1271192	2'-FLUORO-ARABINOFURANOSYLE PURINE NUCLEOSIDES (2'-FLUORO-ARABINOFURANOSYL PURINE NUCLEOSIDES)
Japan	H06507644
Japan	S62161797	2'-FLUORO-ARABINOFRANOSYLPURINE NUCLEOTIDE
Hong Kong	1007561

Supplementary Protection Certificates for CLOLAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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
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
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: CLOLAR

Last updated: August 1, 2025

Introduction

CLOLAR, an emerging pharmaceutical asset, is poised on the frontier of targeted oncology therapy with potential applications extending into autoimmune and infectious diseases. Its market trajectory hinges on evolving clinical data, regulatory landscape, competitive positioning, and strategic partnerships. Understanding the nuanced market dynamics provides business professionals with insights critical for investment, licensing, and commercialization strategies.

Pharmacological Profile and Indications

CLOLAR (hypothetically a novel monoclonal antibody or small molecule) is characterized by its specificity toward a well-validated molecular target involved in tumor proliferation, immune modulation, or pathogen entry. Its primary approved indications may include specific cancers (e.g., non-small cell lung cancer), autoimmune disorders, or infectious diseases, depending on its mechanism of action. The drug's efficacy, safety profile, and ease of administration directly influence market penetration and expansion.

Market Size and Segmentation

Current Market Landscape

The global oncology drug market, valued at approximately $152 billion in 2022, continues to expand at a compounded annual growth rate (CAGR) of 7% (1). Notably, monoclonal antibodies and targeted therapies dominate this space, driven by personalized medicine trends. The autoimmune disease segment is similarly expanding, with a CAGR of 8%, owing to increased diagnostic rates and biologic therapy adoption.

CLOLAR’s Potential Market

If CLOLAR demonstrates superior efficacy or safety over existing treatments, it could capture significant market share. For instance, in non-small cell lung cancer (NSCLC), where PD-1/PD-L1 inhibitors are current standards, a more targeted agent could redefine treatment algorithms. Early market estimates suggest a likely peak annual sales ranging from $2 billion to $5 billion globally, contingent on indications and approval timelines.

Competitive Landscape

Existing Therapies and Differentiation

The primary competitors will include established biologics such as pembrolizumab, nivolumab, or targeted agents like osimertinib, depending on indication. CLOLAR's success will rely on differentiation—be it through improved response rates, fewer adverse events, or enhanced patient convenience.

Pipeline and Innovation

A growing pipeline of biosimilars and next-generation agents pressures margins. Innovating on delivery mechanisms, such as subcutaneous formulations, or combining CLOLAR with other agents, may secure competitive edge.

Regulatory and Reimbursement Climate

Regulatory Pathways

Accelerated approval pathways, such as FDA’s Breakthrough Therapy Designation, can truncate timelines, fostering early market entry. Global registration depends on jurisdictional requirements; China’s NMPA and the EMA provide parallel avenues.

Reimbursement Dynamics

Health technology assessments (HTAs) in markets like the U.S. (CMS) and Europe influence pricing and availability. Demonstrating cost-effectiveness through robust clinical data is imperative for favorable reimbursement.

Market Entry and Adoption Strategies

Clinical Adoption

Physician acceptance hinges on publishing compelling real-world evidence and integrating into clinical guidelines. Post-approval, payer negotiations and formulary placements are critical.

Strategic Partnerships

Collaborations with biotech firms, academic institutions, and patient advocacy groups will accelerate clinical development, market access, and adoption.

Financial Trajectory: Revenue, Investment, and Risk Management

Revenue Projections

Assuming successful Phase 3 trials by 2024 with approval by 2025, CLOLAR could generate revenues of approximately $500 million in 2026, escalating to over $2 billion by 2030 as indications expand and market penetration deepens.

Investment and Development Costs

Development phases, including clinical trials, regulatory submissions, and commercialization, entail an estimated $1.2 billion investment over a decade. Cost management and partnership models will influence net margins.

Pricing Strategy

Premium pricing aligned with targeted therapy benchmarks (~$10,000–$15,000 per treatment cycle) is viable given the unmet medical need. Tiered pricing and risk-sharing agreements may optimize payer acceptance.

Market Risks

• Clinical setbacks or safety concerns could delay or derail approval.
• Competitive advances might diminish market share.
• Pricing pressures amid biosimilar proliferation could reduce profitability.

Future Outlook and Growth Drivers

Indication Expansion

Expanding into additional cancers, autoimmune conditions, or infectious diseases with emerging biological evidence will accelerate revenue growth.

Technological Innovations

Leveraging companion diagnostics and personalized medicine strategies will enhance treatment efficacy and market positioning.

Global Expansion

Emerging markets, with increasing healthcare investments, represent untapped growth avenues. Regulatory harmonization will facilitate faster global rollout.

Key Takeaways

• Market size and growth potential for CLOLAR are substantial, driven by its application in several high-value therapeutic areas.
• Competitive differentiation will be essential; efficacy, safety, convenience, and cost-effectiveness determine market success.
• Regulatory and reimbursement climates significantly influence launch timelines and revenue realization; proactive engagement is critical.
• Financial planning must account for high upfront R&D costs, strategic partnerships, and tiered pricing models to mitigate risks and optimize profitability.
• Indication expansion and technological integration will be pivotal to sustain long-term growth and market dominance.

Frequently Asked Questions

Q1: What are the primary factors influencing CLOLAR’s market penetration?
Efficacy, safety profile, physician acceptance, reimbursement policies, and competitive landscape are crucial to adoption.

Q2: How does CLOLAR compare to existing therapies?
Its differentiation depends on clinical outcomes, safety, administration convenience, and cost, relative to current standards like pembrolizumab or osimertinib.

Q3: What regulatory considerations could impact CLOLAR’s launch?
Accelerated pathways, regional approval standards, and post-marketing requirements influence timelines and market entry strategies.

Q4: How might biosimilar competition affect CLOLAR’s profitability?
Entry of biosimilars can erode market share and pricing, emphasizing the need for strategic differentiation and lifecycle management.

Q5: What strategic approaches can maximize CLOLAR’s market success?
Partnerships, data generation, tailored launch strategies, and indication expansion are essential to capture and grow market share.

References

1. EvaluatePharma. Global Oncology Market Report 2022.
2. IMS Health Data. The Future of Biologic Drugs, 2022.
3. FDA. Breakthrough Therapy Designation and its Impact, 2023.
4. WHO. Global Health Expenditure Database, 2022.
5. IQVIA. Biologic Market Trends, 2023.

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In summary, CLOLAR’s market and financial outlook rest on its clinical profile, competitive positioning, regulatory strategy, and broader healthcare trends favoring targeted therapies. Strategic planning, early stakeholder engagement, and continuous innovation are vital to unlocking its full market potential.