ARIDOL KIT Drug Patent Profile

When do Aridol Kit patents expire, and what generic alternatives are available?

Aridol Kit is a drug marketed by Pharmaxis Europe and is included in one NDA.

The generic ingredient in ARIDOL KIT is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

Summary for ARIDOL KIT

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	176
Clinical Trials:	7
DailyMed Link:	ARIDOL KIT at DailyMed

Recent Clinical Trials for ARIDOL KIT

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

Sponsor	Phase
AllerGen NCE Inc.	N/A
McMaster University	N/A
Pharmaxis	N/A

See all ARIDOL KIT clinical trials

US Patents and Regulatory Information for ARIDOL KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmaxis Europe	ARIDOL KIT	mannitol	POWDER;INHALATION	022368-001	Oct 5, 2010		RX	Yes	Yes

Expired US Patents for ARIDOL KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaxis Europe	ARIDOL KIT	mannitol	POWDER;INHALATION	022368-001	Oct 5, 2010	5,817,028

EU/EMA Drug Approvals for ARIDOL KIT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pharmaxis Europe Limited	Bronchitol	mannitol	EMEA/H/C/001252Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.	Authorised	no	no	no	2012-04-13

International Patents for ARIDOL KIT

See the table below for patents covering ARIDOL KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	3979660
Canada	2183471	PROCEDE ET DISPOSITIF PERMETTANT D'INDUIRE LE RETRECISSEMENT DES VOIES AERIENNES ET/OU LA PRODUCTION DE SALIVE (METHOD AND DEVICE FOR THE PROVOCATION OF AIR PASSAGE NARROWING AND/OR THE INDUCTION OF SPUTUM)
Germany	69536090
China	1075737
Japan	2007056039	METHOD AND DEVICE FOR PROVOCATION OF AIR PASSAGE NARROWING AND/OR INDUCTION OF SPUTUM
Japan	H10501790

Supplementary Protection Certificates for ARIDOL KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748228	SPC/GB11/004	United Kingdom		PRODUCT NAME: MANNITOL; REGISTERED: SE 22708 20061020; UK PL 27944/0001-0001 20071218
0748228	11C0002	France		PRODUCT NAME: MANNITOL; NAT. REGISTRATION NO/DATE: NL 34557 20080819; FIRST REGISTRATION: SE - 22708 20061020

Market Dynamics and Financial Trajectory for ARIDOL KIT

Last updated: July 29, 2025

Introduction

ARIDOL KIT, a diagnostic immunoassay device, primarily targets allergy detection by measuring specific IgE antibodies. Its market positioning hinges on expanding allergy diagnostics, driven by increasing allergy prevalence globally. Analyzing the intricate market forces, competitive landscape, regulatory environment, and revenue potential underscores ARIDOL KIT’s future financial trajectory.

Market Overview

Growing Allergy Prevalence

The global allergy diagnostics market is experiencing robust growth, with estimates projecting a compound annual growth rate (CAGR) of approximately 8–10% over the next five years (1). The rising incidence of allergies across age groups is attributable to urbanization, environmental pollution, and changing lifestyles, fueling demand for reliable diagnostic tools.

Diagnostic Market Segmentation

Allergy diagnostics comprise skin prick tests and in vitro assays like ELISA-based tests. Immunoassay kits such as ARIDOL KIT are favored for their minimally invasive approach, high sensitivity, and specificity. The increasing adoption of in vitro testing, especially amidst concerns over skin prick testing risks, enhances the market size.

Geographic Trends

North America and Europe currently dominate the allergy diagnostics market, driven by healthcare infrastructure, regulatory support, and awareness. However, emerging markets in Asia-Pacific exhibit high growth potential due to rising allergy prevalence and expanding healthcare access.

Competitive Landscape

Key Players

ARIDOL KIT competes with global and regional players, including Thermo Fisher Scientific, Phadia (part of Thermo Fisher), and Omega Diagnostics, among others. Differentiation strategies involve assay accuracy, ease of use, regulatory approvals, and cost-effectiveness.

Market Penetration Strategies

Maximizing market share depends on strategic partnerships with laboratories, effective distribution channels, and accreditation compliance. Entry into emerging markets necessitates navigating local regulatory landscapes and establishing educational initiatives.

Innovation and Product Differentiation

Advances in multiplex testing, automation, and digital integration are shaping the competitive arena. ARIDOL KIT’s success depends on its ability to incorporate these innovations and demonstrate superior clinical performance.

Regulatory and Reimbursement Environment

Regulatory Approvals

Regulatory clearance from bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) is pivotal. Breakthrough device designations, CE marking, and adherence to quality standards (ISO 13485) underpin market access.

Reimbursement Dynamics

Reimbursement policies significantly influence adoption rates. Payer acceptance hinges on demonstrated cost-effectiveness and clinical utility. Positive health economics evaluations bolster payer confidence and facilitate reimbursement.

Financial Trajectory and Revenue Potential

Revenue Streams

Primary revenue derives from direct sales of ARIDOL KITs to clinical labs, hospitals, and diagnostic centers. Ancillary income stems from ongoing reagents, service contracts, and potential licensing agreements.

Market Adoption and Sales Forecasts

Assuming ARIDOL KIT aligns with current market CAGR projections, its revenue growth trajectory can be modeled accordingly. For instance, if initial annual revenues are set at $10 million, a 10% CAGR forecasts revenues reaching ~$16.3 million over five years, assuming steady adoption and expanding market penetration.

Cost and Investment Considerations

Investment in clinical validation studies, regulatory submissions, marketing, and distribution infrastructure influences profitability. Economies of scale, coupled with streamlined manufacturing, can improve margins over time.

Risks and Mitigation

Market risks include regulatory delays, technological obsolescence, fierce competition, and reimbursement hurdles. Strategic investments in R&D, robust regulatory strategies, and early payer engagement mitigate these risks.

Market Entry and Expansion Strategies

Early Adoption and Strategic Partnerships

Engaging early with key opinion leaders and establishing partnerships with large diagnostic networks promote credibility and rapid uptake.

Localization and Market Adaptation

Tailoring product offerings to regional needs, including language, regulatory requirements, and cost sensitivity, enhances acceptance.

Digital and Data Integration

Leveraging digital health integrations opens avenues for remote diagnostics and data analytics, aligning with industry trends and adding value to ARIDOL KIT.

Conclusion

ARIDOL KIT is positioned within a rapidly expanding allergy diagnostics market characterized by increasing allergy prevalence and technological innovation. Its financial prospects hinge on successful regulatory approvals, effectively navigating competitive pressures, and capturing market share in both established and emerging markets. Strategic investments in innovation, market access, and payer engagement will underpin its financial trajectory.

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Key Takeaways

• The global allergy diagnostics market is projected to grow at a CAGR of 8–10%, favoring products like ARIDOL KIT.
• Regulatory approval and reimbursement frameworks are critical to achieving widespread adoption.
• Market entry strategies should focus on geographic expansion, partnerships, and technological differentiation.
• Cost efficiencies and early engagement with payers enhance long-term revenue potential.
• Innovation in multiplex testing and digital integration will be pivotal to maintaining a competitive edge.

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Frequently Asked Questions (FAQs)

1. What are the main factors driving the demand for allergy diagnostic kits like ARIDOL KIT?
Increased prevalence of allergies globally, a shift towards minimally invasive testing, and heightened awareness among healthcare providers drive demand.

2. How does regulatory approval influence ARIDOL KIT's market trajectory?
Regulatory clearance ensures market access, builds credibility, and enhances reimbursement prospects, all of which are essential for revenue growth.

3. What are the primary challenges faced by ARIDOL KIT in expanding its market share?
Intense competition, regulatory complexities, reimbursement hurdles, and technological obsolescence pose significant challenges.

4. Which regions present the most lucrative opportunities for ARIDOL KIT?
North America and Europe due to established healthcare infrastructure, with emerging markets in Asia-Pacific offering high growth potential.

5. How can ARIDOL KIT leverage technological innovations to improve profitability?
Incorporating multiplex testing, automation, and digital health integration can increase efficiency, reduce costs, and meet evolving clinical needs.

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Sources

[1] MarketResearch.com. "Allergy Diagnostics Market Size & Growth." 2022.