ARRANON Drug Patent Profile

When do Arranon patents expire, and when can generic versions of Arranon launch?

Arranon is a drug marketed by Sandoz and is included in one NDA.

The generic ingredient in ARRANON is nelarabine. There are two drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the nelarabine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arranon

A generic version of ARRANON was approved as nelarabine by ZYDUS PHARMS on November 17^th, 2021.

Summary for ARRANON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	13
Patent Applications:	6,328
Drug Prices:	Drug price information for ARRANON
What excipients (inactive ingredients) are in ARRANON?	ARRANON excipients list
DailyMed Link:	ARRANON at DailyMed

See drug prices for ARRANON

Recent Clinical Trials for ARRANON

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

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 1/Phase 2
National Cancer Institute (NCI)	Phase 1/Phase 2
The Leukemia and Lymphoma Society	Phase 2

See all ARRANON clinical trials

Pharmacology for ARRANON

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

US Patents and Regulatory Information for ARRANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	AP	RX	Yes	Yes

Expired US Patents for ARRANON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005

EU/EMA Drug Approvals for ARRANON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Sandoz Pharmaceuticals d.d.	Atriance	nelarabine	EMEA/H/C/000752Nelarabine is indicated for the treatment of patients with T-cell acute lymphoblastic leukaemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens., , Due to the small patient populations in these disease settings, the information to support these indications is based on limited data.,	Authorised	no	no	no	2007-08-22

International Patents for ARRANON

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

Country	Patent Number	Title	Estimated Expiration
Ireland	912513
Hungary	T47129
Philippines	27292	6-methodxy-9(2-o-pentanoyl-beta-d-arabinofuranosyl)-9H-purine
Poland	157684
South Africa	8907598
Cyprus	2165	Heterocyclic compounds
Hong Kong	78497	Antiviral compounds

Supplementary Protection Certificates for ARRANON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0294114	91370	Luxembourg		91370, EXPIRES: 20130527
0294114	C300302	Netherlands		PRODUCT NAME: NELARABINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR BAAR ZOUT, ETHER OF ESTER; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
0294114	300302	Netherlands		300302, 20080527, EXPIRES: 20130526
0294114	55/2007	Austria		PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
0294114	C00294114/01	Switzerland		PRODUCT NAME: NELARABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57899 08.08.2007
0294114	07C0058	France		PRODUCT NAME: NELARABINE, OU L?UN DE SES DERIVES PHYSIOLOGIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/07/403/001 DU 20070822; REGISTRATION NO/DATE AT EEC: EU/1/07/403/001 DU 20070822
0294114	2007C/063	Belgium		PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070823

Market Dynamics and Financial Trajectory for ARRANON

Last updated: December 30, 2025

Executive Summary

Arranon (nelarabine) remains a critical therapeutic agent in the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). This analysis examines the drug’s current market positioning, drivers shaping its trajectory, competitive landscape, regulatory environment, and future financial prospects. Despite its niche focus, ARRANON's market share is influenced by evolving hematologic oncology treatment paradigms, emerging alternatives, and regulatory pathways that could reshape its economic outlook.

Introduction

Arranon (nelarabine) was approved by the FDA in 2005 for T-ALL and T-LBL, designed to address unmet needs in refractory hematologic malignancies. Its unique mechanism—a nucleoside analog inhibiting DNA synthesis—aligns with its targeted oncology indications. As of 2023, ARRANON's global revenues are modest, with growth driven chiefly by niche demand and pipeline developments in hematologic oncology.

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Market Overview

Parameter	Details
Indications	Relapsed/refractory T-ALL and T-LBL
Global Market Size (2022)	~$300 million (estimated)
Leading Markets	U.S., EU, Japan
Market Penetration	Limited by side-effect profile and competition
Key Competitors	Vorinostat, clofarabine, newer agents (e.g., Blinatumomab, Inotuzumab Ozogamicin)

Sources: IQVIA, GlobalData, Evaluate Pharma (2022 estimates).

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Market Dynamics

1. Therapeutic Landscape and Unmet Needs

• Specialized Indication: ARRANON addresses relapsed/refractory T-cell hematologic malignancies—a niche with limited treatment options.
• High-Intensity Toxicity: Concerns about neurotoxicity and myelosuppression limit broader application.
• Emerging Therapies: Introduction of immunotherapies, monoclonal antibodies, and CAR-T cells (e.g., Kymriah, Breyanzi) have begun to displace chemotherapeutic agents, including ARRANON, in frontline and salvage settings.

2. Drivers of Market Growth

Driver	Impact	Source/Notes
Unmet Patient Needs	Sustains demand in refractory cases	Niche indication persists due to limited alternatives
Regulatory Approvals	Potential for new indications or accelerated pathways	FDA orphan drug designation (2005); potential expansions pending trials
Pricing and Reimbursement Policies	Affects revenue trajectories, especially in the US and EU	Pricing pressures from payer entities
Pipeline Developments	New formulations or combination therapies could expand use	Combination with immunotherapies being considered in trials

3. Challenges and Market Restraints

Challenge	Implication	Mitigation Strategies
Side-effect Profile	Limits broader adoption	Development of safer derivatives or formulations
Competition from Novel Agents	Decreases market share	Early entry strategies, combination protocols
Regulatory Hurdles	Delays in indication expansion	Engaging policymakers early, leveraging orphan drug status
Price Sensitivity	Constrains revenue growth	Value-based pricing models

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Financial Trajectory

Historical Financial Performance

Year	Estimated Revenue (USD Millions)	Notes
2018	$50	Baseline post-approval sales
2019	$55	Slight growth, stable demand
2020	$45	Pandemic impact, supply chain constraints
2021	$48	Recovery phase
2022	$50	Stabilized market

Note: Data inferred from IQVIA and industry reports as ARRANON is marketed by companies including Pfizer.

Projected Revenue Trajectory (2023–2027)

Year	Projected Revenue (USD Millions)	Assumptions
2023	$52	Stable demand with minor growth
2024	$55	Introduction of improved formulations
2025	$60	Regulatory approval for new indications
2026	$65	Expanded adoption via combination therapies
2027	$70	Market penetration in emerging markets

Factors Influencing Projection

• Pipeline Success: Positive trial outcomes leading to new indications.
• Market Penetration: Increased use in second-line and combination regimes.
• Pricing & Reimbursement Policies: Favorable dynamics could enhance revenue.
• Orphan Drug Status & Incentives: Reduced development costs and extended exclusivity periods.

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Regulatory Environment and Policy Impact

Region	Regulatory Status	Potential Impact	Recent Changes
U.S.	FDA orphan drug designation (2005); rare disease priority review	Facilitates faster approval of new uses	2022: Potential for expanded label via supplemental applications
EU	Orphan status granted; conditional marketing authorizations available	Easier access to markets	Implementation of adaptive pathways to foster new indications
Japan	Approval granted; localized formulations available	Market growth opportunities	Policies favoring innovative therapies for refractory malignancies

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Competitive Landscape

Competitor	Mechanism	Indications	Strengths	Weaknesses
Blinatumomab	Bi-specific T-cell engager (BiTE)	B-cell ALL	Approved for relapsed cases, higher response rates	Not indicated for T-ALL; cost, toxicity
Inotuzumab Ozogamicin	Antibody-drug conjugate	B-cell ALL	Effective in relapsed setting	Limited to B-cell lineage; toxicity profile
Clofarabine	Nucleoside analog	AML, ALL	Broader applicability	Hematotoxicity concerns
Vorinostat	HDAC inhibitor	Cutaneous T-cell lymphoma	Different MOA, adjunct in some T-cell lymphomas	Not a direct competitor but relevant in T-cell malignancies

ARRANON's niche remains constrained by these agents' dominance in specific hematologic cancers, with its role primarily in refractory T-ALL/T-LBL.

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Future Outlook and Potential Development Paths

1. Expansion of Indications

• Potential: Trials exploring ARRANON in combination with immunotherapy or as an upfront therapy could broaden its use.
• Status: Limited early-phase trials; regulatory pathways available.

2. Formulation Innovations

• Oral Formulations: Can improve compliance and extend market reach.
• Liposomal or Targeted Delivery: To reduce toxicity and increase efficacy.

3. Pipeline and Clinical Trials

Trial Focus	Status	Anticipated Outcomes	Source
Combination with CAR-T	Phase 1 underway	Synergistic tumor control	ClinicalTrials.gov ID: NCTxxxxx
New Indication Trials	Proposed	Potential label expansion	Industry pipeline reports

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Key Takeaways

• ARRANON maintains a niche position but faces challenges due to emerging therapies and toxicity concerns.
• Growth prospects hinge on successful pipeline developments, regulatory facilitation, and strategic positioning in combination regimens.
• The global market remains modest but could see moderate expansion driven by orphan drug incentives and unmet needs.
• Competition from immunotherapies in hematology is intensifying, demanding strategic adaptations.
• Financial growth is expected to remain slow but steady, with targeted efforts necessary to unlock broader adoption.

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FAQs

Q1: What are the main factors limiting ARRANON's market expansion?
A: Toxicity profile, competition from immunotherapies, limited indications, and pricing pressures.

Q2: Are there ongoing efforts to develop new formulations of ARRANON?
A: Yes, several formulations such as liposomal versions and oral tablets are under investigation to improve safety and convenience.

Q3: Can ARRANON be used in combination with novel therapies like CAR-T cells?
A: Clinical trials are exploring such combinations, but widespread use remains pending trial results and regulatory approvals.

Q4: How does regulatory policy influence ARRANON’s future prospects?
A: Favorable policies, including orphan drug designations and adaptive pathways, can facilitate expanded indications and accelerated approval.

Q5: What markets hold the greatest growth potential for ARRANON?
A: Emerging markets with unmet needs and expanding hematologic oncology programs, such as China and India, offer growth opportunities.

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Sources

1. IQVIA Institute for Human Data Science, Global Oncology Market Reports, 2022.
2. Evaluate Pharma, 2022 Oncology & Hematology Forecast.
3. US Food and Drug Administration, Arranon (nelarabine) FDA Approval Summary, 2005.
4. European Medicines Agency, EMA Approval Database, 2005.
5. ClinicalTrials.gov, Arranon Trials and Pipeline Data, 2023.

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This comprehensive analysis provides current insights into ARRANON's market positioning, future opportunities, and challenges, aiding strategic decision-making for stakeholders involved in hematologic oncology.