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. Eight 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:	5,116
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

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	4,918,179
Genzyme	CLOLAR	clofarabine	SOLUTION;INTRAVENOUS	021673-001	Dec 28, 2004	5,384,310

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
Canada	1271192	2'-FLUORO-ARABINOFURANOSYLE PURINE NUCLEOSIDES (2'-FLUORO-ARABINOFURANOSYL PURINE NUCLEOSIDES)
Germany	122006000056
Germany	3687397
European Patent Office	0219829	2-FLUORO-ARABINOFURANOSYL PURINE NUCLEOSIDES
Japan	H0723395
Japan	S62161797	2'-FLUORO-ARABINOFRANOSYLPURINE NUCLEOTIDE

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
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	300247	Netherlands		300247, 20100523, EXPIRES: 20150522
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

Last updated: June 13, 2026

CLOLAR (clofarabine) Market Dynamics and Financial Trajectory: Growth Drivers, Patent/Exclusivity Timeline, and Revenue Exposure

CLOLAR (clofarabine) is a hospital-administered, oncology purine nucleoside analog with commercial concentration in the pediatric acute lymphoblastic leukemia (ALL) setting. The financial trajectory is shaped less by consumer-style switching and more by (1) line-of-therapy rules in pediatric ALL, (2) competition from other salvage-regimen cytotoxics and emerging targeted therapies, and (3) erosion of revenue potential as exclusivity and patent barriers decline. In practice, CLOLAR’s revenue profile is typically dominated by limited-duration treatment courses, payer controls, and procurement dynamics at specialty oncology centers rather than broad outpatient uptake.

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What is CLOLAR and how is it used commercially?

CLOLAR is clofarabine, a purine nucleoside analog used in pediatric acute lymphoblastic leukemia (ALL) and related salvage settings after prior therapy. Sales are generally constrained by:

• Restricted patient population: pediatric oncology cohorts and salvage-treatment decision trees.
• Short course duration: chemotherapy cycles reduce cumulative exposure per patient.
• Specialty channel access: hospital pharmacy and oncology procurement, with strict formulary and contract requirements.
• Clinical regimen substitution: salvage protocols often mix or replace agents based on tolerability and local practice patterns.

Which dosing and administration model affects revenue?

Clofarabine is infused intravenously, which ties utilization to oncology center capacity and physician selection. Revenue is driven by number of treated pediatric patients and regimen adoption in salvage pathways, not broad chronic adherence.

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How do market dynamics shape CLOLAR sales growth or decline?

1) Pediatric oncology treatment-line friction

Pediatric ALL salvage is characterized by “limited options” in many markets, but adoption still depends on:

• physician experience with clofarabine toxicity management,
• insurer authorization requirements,
• institutional protocol alignment.

Even when clofarabine remains an accepted option, financial outcomes depend on how often it is chosen versus comparators in the same salvage line.

2) Payer contracting and hospital procurement

CLOLAR competes in hospital tender environments where:

• price concessions and rebates can materially affect net revenue,
• contracting may restrict use to specific centers,
• inventory handling and wholesaler terms can drive short-term variability.

3) Competitive substitution and regimen evolution

Revenue exposure is affected by competing salvage regimens, including other cytotoxics used in pediatric ALL salvage and subsequent growth areas in pediatric hematologic malignancies such as targeted approaches. When protocols evolve, clofarabine can experience utilization shifts even without formal regulatory changes.

4) Supply and operational continuity

For specialty oncology injectables, commercial stability depends on uninterrupted supply chain operations and manufacturing continuity. Any supply disruptions can convert into lost demand that may not fully return later because treatment decisions are time-critical.

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When does CLOLAR lose exclusivity, and what does that mean for financial exposure?

CLOLAR’s financial trajectory is closely linked to the expiration of composition, formulation, method-of-use, and exclusivity protections that cover specific dosage forms and uses. In practical terms, investors and business partners focus on two dates:

• Patent expiration (composition and formulation)
• Regulatory exclusivity windows tied to the first FDA approval (and any exclusivity extensions)

For a hospital-administered oncology drug like CLOLAR, the major revenue shock typically comes from generic availability if bioequivalence is straightforward for the dosage form and no remaining formulation-specific patents block approval.

Because this prompt did not provide Orange Book listings, patent numbers, or FDA approval dates for CLOLAR, the specific expiration timeline cannot be stated accurately here.

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What patents protect CLOLAR, and how many are in the estate by type?

A complete patent estate view requires Orange Book listings and associated patent families mapped to:

• active ingredient composition,
• pharmaceutical formulation (stability, excipients, pH),
• method-of-use (pediatric regimens, dosing schedules),
• manufacturing process claims.

This prompt does not include the Orange Book patent list, application numbers, or patent publications for CLOLAR. Without that, the count and types of patents cannot be provided without risking material error.

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What is the Orange Book status of CLOLAR?

Orange Book status is the basis for assessing:

• which patents are listed,
• whether patents are tied to approved NDA claims,
• and whether generic competition is likely via Paragraph IV routes.

This request does not include CLOLAR’s NDA number or Orange Book listing details. A precise Orange Book status statement cannot be produced.

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Do Paragraph IV challenges exist for CLOLAR, and which companies are challenging?

Paragraph IV challenges drive:

• litigation risk,
• settlement leverage,
• and launch timing for generics.

A reliable assessment requires:

• any FDA notice of Paragraph IV certifications,
• litigation docket entries by generic filers,
• and settlement agreements tied to exclusivity or launch dates.

This prompt provides no Paragraph IV or litigation record details specific to CLOLAR, so the list of challengers and case status cannot be stated accurately.

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How strong is the patent estate for CLOLAR?

Patent strength for a hospital oncology injectable is typically evaluated using:

• remaining active patents by claim type,
• injunction plausibility,
• breadth of coverage (formulation vs core active),
• and vulnerability to design-around.

A defensible strength score requires the underlying listed patents and claim coverage map. No patent list is provided in the prompt.

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What formulations are protected by CLOLAR patents?

Formulation protection can delay generic substitution when:

• specific excipient systems, pH control, or stability requirements remain patent-protected,
• or the drug is only commercialized in a particular dosage form that is covered by formulation claims.

No CLOLAR dosage-form patent list is included in the prompt, so formulation-by-formulation protection cannot be enumerated.

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What generic entry risks exist for CLOLAR?

Generic entry risks in an oncology injectable are driven by:

• ease of manufacturing and analytical comparability,
• whether formulation/process patents block approval,
• and whether the remaining patent estate leaves credible launch routes.

Without Orange Book data or patent expiration records, generic timing and risk levels cannot be quantified.

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How does CLOLAR compare with other pediatric ALL salvage oncology drugs on commercial dynamics?

Relative commercial dynamics typically differ across:

• targeted vs cytotoxic agents,
• inpatient vs outpatient administration,
• and payer authorization complexity.

However, without specifying comparator products, line-of-therapy targets, and the timing of patent events for each comparator, a precise side-by-side market share or revenue trajectory comparison cannot be produced from the information provided.

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What FDA regulatory pathway issues affect CLOLAR revenue?

Key revenue-relevant regulatory factors include:

• stability and manufacturing changes requiring supplemental applications,
• labeling specificity that can influence formulary decisions,
• and any post-approval safety label changes affecting utilization.

This prompt does not include the CLOLAR regulatory history, label milestones, or FDA supplement events.

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Commercial trajectory: what drives revenue volatility for CLOLAR?

Even for a stable hospital oncology drug, revenue tends to vary due to:

• Patient throughput and site adoption cycles: pediatric oncology centers may adjust treatment protocols.
• Budget cycles and tender timing: procurement can shift quarterly.
• Contracting and rebate changes: net pricing may move independent of list price.
• Supply continuity: allocation events can suppress demand.
• Competitive switching: new salvage options can reduce clofarabine use.

For the financial trajectory, these factors usually create:

• uneven quarterly sales,
• slower multi-year growth even if the product is clinically used,
• and faster declines when generic competition arrives or protocols shift.

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License and settlement outcomes: how do they affect CLOLAR financial outcomes?

Settlement agreements and licensing arrangements affect revenue by determining:

• whether a generic can launch immediately or is delayed,
• whether “authorized” supply replaces or coexists with incumbent products,
• and whether new entrants face market access barriers.

This prompt includes no litigation or settlement record for CLOLAR, so specific outcomes cannot be listed.

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Key metrics investors use to track CLOLAR performance

In the absence of product-specific financial statements in the prompt, the following are the primary KPIs used to monitor trajectory for niche oncology injectables:

• Unit volume (vials or mg equivalents) by quarter
• Net price trend after rebates, chargebacks, and contracting
• Purchaser mix (GPO contracts, large oncology centers, IDNs)
• Demand elasticity under payer edits and prior authorization rules
• Treatment intensity trends in pediatric ALL salvage
• Inventory channel behavior (on-hand supply at wholesalers and hospitals)
• Net sales vs gross margin trajectory (contract rate impacts)

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Key Takeaways

• CLOLAR’s market dynamics are driven by pediatric ALL salvage protocol selection, hospital procurement behavior, and competitive substitution rather than consumer switching.
• The primary long-horizon financial risk is generic entry once patent and exclusivity barriers decline, which typically causes step-down revenue.
• Revenue volatility is usually explained by tender cycles, contracting changes, and supply continuity more than by demand destruction within the clinical community.
• A precise exclusivity, Orange Book status, Paragraph IV landscape, and patent strength assessment cannot be completed from the information provided in this prompt.

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FAQs

1) Is CLOLAR a high-growth oncology drug or a niche stabilizer?

CLOLAR generally behaves like a niche hospital oncology product with limited patient population and course-based utilization rather than a high-growth platform.

2) What drives CLOLAR demand in pediatrics?

Demand is driven by pediatric ALL salvage selection, center protocol preferences, payer authorization outcomes, and treatment cycle timing.

3) What factors most affect CLOLAR net pricing versus list price?

Contracting terms, rebates, chargebacks, and formulary status drive net pricing movement.

4) How does generic competition typically impact CLOLAR revenue?

Generic entry usually causes rapid unit-share erosion and net price compression, especially if no remaining formulation or method-of-use patents block substitution.

5) What operational issues can create revenue swings for CLOLAR?

Supply continuity, allocation events, manufacturing disruptions, and inventory placement decisions can materially affect quarterly reported sales.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Consulted source not provided in prompt).
2. FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration. (Consulted source not provided in prompt).