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
Patent Applications:	4,234
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

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/001252 Bronchitol 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
Australia	PM411494
Japan	2013049708	METHOD AND APPARATUS FOR PROVOCATION OF AIRWAY NARROWING AND/OR INDUCTION OF SPUTUM
New Zealand	281522	TESTING FOR ASTHMA SUSCEPTABILITY COMPRISING INHALATION OF POWDER WHICH CAN CHANGE AIRWAY SIZE AND MEASURING CHANGE IN AIRFLOW

Supplementary Protection Certificates for ARIDOL KIT

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

ARIDOL KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Aridol Kit

Introduction

The Aridol® Bronchial Challenge Test Kit, developed by Pharmaxis Ltd, is a diagnostic tool designed to assess airway hyperresponsiveness, particularly in patients suspected of having asthma or exercise-induced bronchoconstriction (EIB). Here, we delve into the market dynamics and financial trajectory of the Aridol Kit.

Development and Regulatory Milestones

The journey of Aridol began with research initiatives in the early 1990s, supported by the National Health and Medical Research Council (NHMRC) of Australia. Pharmaxis Ltd acquired the patent for mannitol-based products in 2001 and subsequently conducted extensive clinical trials[5].

• Key Regulatory Approvals:
  • 2006: Aridol received its first marketing approval from the Australian Therapeutic Goods Administration (TGA)[2][5].
  • 2009: Approved by the European Medicines Agency (EMA)[5].
  • 2010: Approved by the US Food and Drug Administration (FDA)[5].

Market Launch and Sales Performance

Initial Launch and Sales

The commercial launch of Aridol marked a significant milestone for Pharmaxis Ltd. In the financial year ending 2006, the company reported the first commercial sales of Aridol, including sales to the US market[2].

• Early Sales Figures:
  • By the end of 2006, over 2,600 Aridol kits had been manufactured and shipped[2].

Regional Sales Performance

Aridol sales have been tracked across various regions, providing insights into its market penetration.

• Australia and Europe:
  • Sales in Australia and Europe have been consistent, though they have faced fluctuations. For instance, in the half-year ended December 2022, Aridol sales in Australia were $184,000, and in Europe, they were $189,000[3].
• USA and Canada:
  • Sales in the US and Canada have been less robust, partly due to market disruptions and competition. In the same half-year period, no significant sales were reported in these regions[3].
• South Korea:
  • Sales in South Korea have shown some stability, with $180,000 in sales for the half-year ended December 2022[3].

Financial Trajectory

Revenue Trends

The revenue generated from Aridol sales has experienced ups and downs over the years.

• Recent Decline:
  • For the half-year ended December 2022, Aridol sales were $0.5 million, down from $0.9 million in the corresponding period of 2021[3].
• Impact of COVID-19:
  • The COVID-19 pandemic has significantly impacted the sales of Aridol, along with other pharmaceutical products. Supply chain disruptions and changes in distributor arrangements have contributed to this decline[3].

Cost Management and Investment

Pharmaxis Ltd has been diligent in managing its costs and investing in its product pipeline.

• Drug Development Expenses:
  • The company has reduced its drug development expenses, from $1.3 million in the half-year ended December 2021 to $0.9 million in the half-year ended December 2022[3].
• Sales and Marketing Expenses:
  • Sales and marketing expenses have also been reduced, reflecting cost-cutting measures. These expenses were $0.1 million in the half-year ended December 2022, down from $0.4 million in the previous period[3].

Market Dynamics and Challenges

Competitive Landscape

The diagnostic market for respiratory conditions is competitive, with various tests and treatments available.

• Bronchial Challenge Tests:
  • Aridol competes with other bronchial challenge tests, including exercise testing and methacholine challenge tests. However, its convenience and standardized kit format have been key selling points[1].

Regulatory and Reimbursement Challenges

Navigating regulatory and reimbursement landscapes is crucial for the success of pharmaceutical products.

• Regulatory Approvals:
  • While Aridol has secured approvals in major markets, maintaining compliance with regulatory requirements is ongoing. The company has faced delays and disruptions due to regulatory processes and reimbursement approvals[3].
• Reimbursement Issues:
  • Changes in reimbursement policies, especially in the US, have impacted sales. For example, the recent reimbursement approval for a new therapy has disrupted Aridol sales in some regions[3].

Future Outlook

Growth Prospects

Despite current challenges, there are opportunities for growth.

• Expanding Distribution:
  • Pharmaxis is working to expand its distribution network and resolve supply chain issues. For instance, packaging supply constraints in Europe have been resolved, and product shipments have resumed[3].
• New Markets:
  • The company is exploring new markets and partnering arrangements to boost sales. The acquisition of the Orbital inhaler technology by Aptar Pharma could also open new avenues for delivering high-payload dry powder formulations[3].

Financial Sustainability

The company's financial sustainability is dependent on several factors.

• Sales Targets:
  • Achieving sales targets for approved products, particularly Aridol and Bronchitol, is critical. Additional funding through new partnering arrangements, R&D tax incentives, and equity share capital is also being pursued[3].
• Cost Management:
  • Effective cost management and investment in the drug development pipeline are essential for maintaining a strong financial position[3].

Key Takeaways

• Regulatory Milestones: Aridol has secured approvals in Australia, Europe, and the US, marking significant milestones in its commercial journey.
• Sales Performance: Sales have been affected by the COVID-19 pandemic, regulatory issues, and changes in distributor arrangements.
• Financial Management: The company is focusing on cost reduction and seeking additional funding to support its operations.
• Market Dynamics: The competitive landscape and regulatory challenges require continuous adaptation and innovation.

FAQs

What is the Aridol Bronchial Challenge Test Kit used for?

The Aridol Kit is used to assess patients with respiratory symptoms suspected of having asthma or exercise-induced bronchoconstriction (EIB) by testing airway hyperresponsiveness[1].

Who developed the Aridol Kit?

The Aridol Kit was developed by Pharmaxis Ltd, an Australian pharmaceutical company, through a licensing agreement with the Sydney South West Area Health Service[2].

What are the key regulatory approvals for Aridol?

Aridol has been approved by the Australian TGA, European Medicines Agency (EMA), and the US FDA[2][5].

How has the COVID-19 pandemic impacted Aridol sales?

The pandemic has caused supply chain disruptions, changes in distributor arrangements, and overall market challenges, leading to a decline in sales[3].

What are the future growth prospects for Aridol?

Pharmaxis is working to expand distribution, resolve supply chain issues, and explore new markets and partnering arrangements to boost sales[3].

Sources

1. Methapharm Respiratory, Aridol® Bronchial Challenge Test Kit, https://methapharmrespiratory.com/aridol-bronchial-challenge-test-kit/
2. Annual Reports, Annual Report 2006 Quality of life through innovative medicine, https://www.annualreports.com/HostedData/AnnualReportArchive/p/ASX_PXS_2006.pdf
3. Pharmaxis Ltd, Directors’ Report For the half-year ended 31 December 2022, https://cdn-api.markitdigital.com/apiman-gateway/ASX/asx-research/1.0/file/2924-02630176-2A1430130?access_token=83ff96335c2d45a094df02a206a39ff4
4. ScienceDirect, Asthma control in patients on fixed dose combination evaluated with mannitol challenge test, https://www.sciencedirect.com/science/article/pii/S0954611113004915
5. NHMRC, Aridol® and Bronchitol®, https://www.nhmrc.gov.au/about-us/resources/impact-case-studies/aridolr-and-bronchitolr