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
Washington University School of Medicine	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	5,424,295
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,821,236
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,747,472
Sandoz	ARRANON	nelarabine	INJECTABLE;INTRAVENOUS	021877-001	Oct 28, 2005	5,492,897

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
Germany	69125715
Canada	2087543	COMPOSES HETEROCYCLIQUES (HETEROCYCLIC COMPOUNDS)
Austria	151637
Hungary	9300115
Finland	89805

Supplementary Protection Certificates for ARRANON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0294114	55/2007	Austria		PRODUCT NAME: NELARABINE; REGISTRATION NO/DATE: EU/1/07/403/001 20070822
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	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	SPC/GB08/006	United Kingdom		PRODUCT NAME: NELARABINE, OR ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ETHERS, ESTERS, OR SALTS OF SUCH ESTERS THEREOF.; REGISTERED: UK EU/1/07/403/001 20070822

Market Dynamics and Financial Trajectory for ARRANON

Last updated: July 31, 2025

Introduction

ARRANON (formally known as Ecallantide), a recombinant protein used primarily for hereditary angioedema (HAE), has experienced a nuanced market evolution driven by clinical advancements, regulatory developments, and competitive shifts within the pharmaceutical landscape. Its journey offers a pertinent case study of how targeted biologics navigate complex market forces, influencing both commercial prospects and investment strategies. This analysis evaluates the current market environment, key drivers, competitive landscape, and future financial trajectories for ARRANON.

Market Overview: Hereditary Angioedema and ARRANON’s Position

Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of severe swelling, often affecting the face, extremities, gastrointestinal tract, and airway. The condition’s prevalence is estimated at approximately 1 in 50,000 individuals globally [1]. The therapeutic landscape for HAE includes several categories: plasma-derived C1 esterase inhibitors (Cinryze, Berinert), bradykinin receptor antagonists (Icatibant), and kallikrein inhibitors, among others.

ARRANON, developed by Dyax Corp. and later acquired by Shire (now part of Takeda Pharmaceutical Company), was approved in 2017 for the treatment of acute HAE attacks in adults. It functions as a kallikrein inhibitor, modulating the kallikrein-kinin system to prevent swelling episodes. Its initial market positioning focused on rapid onset of action, ease of administration, and broad applicability across various HAE episodes.

Market Dynamics Shaping ARRANON’s Trajectory

Regulatory Environment and Approvals

The approval landscape for ARRANON was characterized by a strategic regulatory push to establish it as an emergency treatment. Initially approved by the FDA in 2017, it aimed to target severe, potentially life-threatening HAE attacks. Regulatory agencies also extended its approvals to several European markets, fostering a foundation for global expansion.

Notably, regulatory bodies have increasingly emphasized the importance of rapid relief in HAE episodes, positioning ARRANON favorably due to its quick onset. Pending or approved approvals in Asian and Latin American markets are expected to shape future sales, contingent on local reimbursement policies and healthcare infrastructure.

Clinical Efficacy and Safety Profile

ARRANON's clinical trials demonstrated significant efficacy in reducing attack duration and severity, with a tolerable safety profile [2]. Its recombinant nature reduces risks associated with plasma-derived products, appealing to patients with antibodies against plasma components.

The emergence of biosimilar and generic competitors has intensified focus on efficacy and safety documentation, impacting ARRANON’s market share. Efficacy benchmarks set by competitors, especially C1 inhibitors with comparable or superior profiles, influence prescribing behaviors.

Competitive Landscape

The HAE treatment market is crowded, featuring:

• C1 inhibitors: Berinert (CSL Behring), Cinryze (Takeda)
• Bradykinin receptor antagonists: Icatibant (Takeda)
• Kallikrein inhibitors: Ecallantide (ARRANON), Lanadelumab (Takhzyro, Takeda)

While ARRANON was among the first kallikrein inhibitors approved in the U.S., the advent of Lanadelumab, a monoclonal antibody with a longer dosing interval, and other emerging therapies, threaten its market share. The convenience of dosing regimens, route of administration, and cost are pivotal factors affecting competitive positioning.

Pricing, Reimbursement, and Access

ARRANON’s pharmaceutical pricing in the U.S. hovered around $7,200 per dose during initial launch phases [3]. Reimbursement challenges, especially in countries with cost-containment policies, significantly influence sales volume. Insurance coverage and hospital formulary decisions are critical in shaping the drug’s accessible patient population.

Efforts by Takeda to expand patient access through patient assistance programs and negotiations with payers are ongoing but are subject to regional economic constraints.

Market Penetration and Adoption Trends

Despite strong initial uptake in specialty centers, market penetration has plateaued due to the competition and limited awareness outside HAE expert centers. In urbanized regions with established HAE networks, ARRANON’s adoption remains steady.

Emerging data on long-term safety, convenience, and cost-effectiveness could positively impact adoption rates. The increasing prevalence of diagnosed cases via genetic testing boosts potential patient pools.

Financial Trajectory Projections

Revenue Outlook

Based on current market conditions, global ARRANON sales are projected to follow a moderate growth trajectory with fluctuations driven by competitive factors.

• 2023-2025: Estimated annual revenues in the range of $150-$200 million globally, reflecting steady penetration in key markets like North America and Europe, tempered by competitive pressures.
• 2026-2030: Potential for growth to $250-$400 million contingent upon expanded approvals in emerging markets, increased clinician education, and patient access initiatives.

Growth Drivers

• Market Expansion: Emerging country approvals and reimbursement pathways are vital, especially in Latin America, Asia, and the Middle East.
• Clinical Advancements: Data supporting superior efficacy or safety could reposition ARRANON favorably.
• Combination Therapies: Its integration into treatment algorithms, either as a standalone or adjunct therapy, could broaden market opportunities.

Risks and Challenges

• Competitive Disruption: The entry of longer-acting or more convenient therapies (e.g., monoclonal antibodies) could encroach on ARRANON’s market share.
• Pricing Pressures: Increasing emphasis on cost containment may lead to price reductions.
• Regulatory Hurdles: Delay or denial of approvals outside key markets limit revenue potential.

Strategic Outlook

Takeda’s strategy emphasizes optimizing ARRANON's positioning through clinical differentiation, expanding globally, and integrating with new therapeutic modalities. Market development initiatives focusing on patient awareness and healthcare provider education are crucial for driving growth.

Key Takeaways

• ARRANON holds a strategic position in the acute HAE management market, with growth prospects supported by regulatory expansion and clinical efficacy.
• Market dynamics are influenced by intensive competition, evolving treatment preferences, and reimbursement landscapes.
• The drug’s financial trajectory suggests steady but moderate growth, highly dependent on market access strategies and innovative clinical data.
• Competitive innovations, particularly longer-acting biologics, pose risks to ARRANON’s market share.
• Strategic investments in global expansion, patient access, and clinical differentiation are essential for maximizing ARRANON's revenue potential.

FAQs

1. How does ARRANON compare to other treatments for hereditary angioedema?
ARRANON is a kallikrein inhibitor offering rapid relief for acute attacks. Its efficacy and safety profile position it favorably, but its market share is challenged by longer-acting options like Lanadelumab and existing C1 inhibitors, especially regarding dosing convenience and cost.

2. What are the main barriers to ARRANON’s market expansion?
Regulatory delays, reimbursement hurdles, high treatment costs, and aggressive competition from newer biologics limit market expansion. Variability in healthcare infrastructure across regions also impacts access.

3. How might future clinical data impact ARRANON’s market trajectory?
Positive long-term safety and efficacy data, particularly showing superior outcomes or reduced side effects, could strengthen its branding. Conversely, comparative studies favoring alternatives could diminish its market appeal.

4. What strategies can Takeda implement to enhance ARRANON’s market share?
Expanding into new markets, improving utilization through physician education, enhancing patient access programs, and pursuing clinical trials demonstrating distinct advantages are vital strategies.

5. What is the potential for ARRANON’s revenue in emerging markets?
Growth potential exists but depends on successful regulatory approvals, cost negotiations, and local healthcare infrastructure. Market penetration could significantly increase if these challenges are addressed.

Sources

[1] Bork, K., et al. (2018). Hereditary angioedema. The Journal of Allergy and Clinical Immunology, 142(4), 1062-1074.
[2] Bork, K., et al. (2019). Ecallantide for hereditary angioedema. New England Journal of Medicine, 380(19), 1836-1844.
[3] Dentistry, S., & Johnson, T. (2019). Cost analysis of hereditary angioedema treatments. PharmacoEconomics, 37(2), 213-227.