ARIKAYCE KIT Drug Patent Profile

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

Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has two hundred and eight patent family members in twenty-nine countries.

The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Arikayce Kit

A generic version of ARIKAYCE KIT was approved as amikacin sulfate by MEITHEAL on September 28^th, 1993.

Summary for ARIKAYCE KIT

International Patents:	208
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	ARIKAYCE KIT at DailyMed

Recent Clinical Trials for ARIKAYCE KIT

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Insmed Incorporated	Phase 3
Insmed Incorporated	Phase 2

See all ARIKAYCE KIT clinical trials

Pharmacology for ARIKAYCE KIT

Drug Class

Aminoglycoside Antibacterial

US Patents and Regulatory Information for ARIKAYCE KIT

ARIKAYCE KIT is protected by thirteen US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	8,802,137		Y
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	10,251,900
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	9,566,234		Y
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018		RX	Yes	Yes	8,226,975		Y

Expired US Patents for ARIKAYCE KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	8,802,137
Insmed Inc	ARIKAYCE KIT	amikacin sulfate	SUSPENSION, LIPOSOMAL;INHALATION	207356-001	Sep 28, 2018	9,827,317

International Patents for ARIKAYCE KIT

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

Country	Patent Number	Title	Estimated Expiration
South Korea	20080027888	SUSTAINED RELEASE OF ANTIINFECTIVES
Poland	2852391
Israel	216401	תכשיר אנטי-זיהומי המכיל אמיקצין ותערובת שומנים ושיטה להכנתו (Antiinfective formulation comprising amikacin and a lipid mixture and method of its preparation)
Japan	5684343

ARIKAYCE KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ARIKAYCE KIT

Introduction

ARIKAYCE (amikacin liposome inhalation suspension) is a critical drug developed by Insmed, Inc., primarily used for the treatment of Mycobacterium avium complex (MAC) lung infection. Here, we delve into the market dynamics and financial trajectory of ARIKAYCE, highlighting its growth, revenue, and future prospects.

Market Growth and Revenue

Global Revenue

In the third quarter of 2024, ARIKAYCE achieved total revenue of $93.4 million, reflecting an 18% growth compared to the third quarter of 2023. This growth is consistent across various regions, with the U.S., Japan, and Europe and the rest of the world showing year-over-year growth of 13%, 31%, and 45%, respectively[2][5].

Regional Performance

• U.S.: ARIKAYCE net sales in the U.S. were $66.9 million in the third quarter of 2024, with a 13% year-over-year growth.
• Japan: Sales in Japan reached $21.0 million, with a 31% year-over-year growth.
• Europe and Rest of World: This region saw significant growth, with sales of $5.6 million, a 45% increase from the previous year[2].

Full-Year Projections

Insmed has reiterated its sales guidance for full-year 2024 global ARIKAYCE revenues, expecting a range of $340 million to $360 million. This represents a 15% year-over-year growth at the midpoint compared to 2023[2][3].

Clinical and Commercial Initiatives

Clinical Trials and Expansion

Insmed is actively engaged in several clinical trials to expand the label for ARIKAYCE. The ENCORE study, which targets patients with newly diagnosed or recurrent MAC lung infection, has closed screening for new patients and is expected to exceed its target enrollment of 400 patients. The company is also scheduled to meet with the FDA in the fourth quarter of 2024 to discuss the possibility of an accelerated approval based on the positive Phase 3 ARISE trial data[2].

Sales Force Expansion

Insmed has fully deployed an expanded U.S. sales force, focusing on bronchiectasis disease-state awareness and supporting the growth of ARIKAYCE. This strategic move is aimed at preparing the market for the anticipated launch of brensocatib in mid-2025[2].

Financial Health and Investments

Cash and Marketable Securities

As of September 30, 2024, Insmed had approximately $1.5 billion in cash, cash equivalents, and marketable securities. This robust financial position is bolstered by a renegotiated term loan with Pharmakon, resulting in a lower cost of capital and an additional $150 million in proceeds expected in the fourth quarter of 2024[2].

Operating Expenses

Insmed's operating expenses include significant investments in research and development, selling, general, and administrative activities. For the third quarter of 2024, research and development expenses were $150.8 million, while selling, general, and administrative expenses were $118.9 million. The company continues to allocate over 80% of its total expenditures to mid- to late-stage and commercial programs, with less than 20% dedicated to early-stage research[2].

Market Dynamics and Competitive Landscape

Disease-State Awareness

Insmed's efforts to increase disease-state awareness for bronchiectasis and MAC lung infection are crucial in expanding the market for ARIKAYCE. The company's expanded sales force and clinical initiatives are designed to educate healthcare providers and patients about the benefits of ARIKAYCE, thereby driving market growth[2].

Regulatory Environment

The regulatory environment remains favorable for ARIKAYCE, with ongoing discussions with the FDA for potential label expansions. The positive Phase 3 ARISE trial data and the progress in the ENCORE study are key factors in Insmed's regulatory strategy[2].

Future Prospects

Brensocatib Launch

The NDA submission for brensocatib in bronchiectasis is on track for the fourth quarter of 2024, with a potential U.S. launch expected in mid-2025. This upcoming launch is anticipated to further strengthen Insmed's market position and contribute to the company's revenue growth[2].

Global Expansion

Insmed continues to expand its global footprint, with ARIKAYCE approved in several countries. The company's strategy includes increasing access to ARIKAYCE through compassionate use programs, such as the one initiated in France for the treatment of adult patients with Mycobacterium abscessus lung infection[4].

Key Takeaways

• Revenue Growth: ARIKAYCE has demonstrated consistent revenue growth, with an 18% increase in the third quarter of 2024 compared to the same period in 2023.
• Clinical Initiatives: Insmed is advancing several clinical trials to expand the label for ARIKAYCE and is on track for an NDA submission for brensocatib.
• Financial Strength: The company has a robust financial position with over $1.5 billion in cash, cash equivalents, and marketable securities.
• Market Expansion: Efforts to increase disease-state awareness and expand global access are driving market growth for ARIKAYCE.
• Future Prospects: The anticipated launch of brensocatib and potential label expansions for ARIKAYCE position Insmed for continued growth and market dominance.

FAQs

Q: What is the current revenue growth trend for ARIKAYCE?

A: ARIKAYCE has shown an 18% revenue growth in the third quarter of 2024 compared to the same period in 2023, with double-digit growth in the U.S., Japan, and Europe[2].

Q: What are the key clinical initiatives for ARIKAYCE?

A: Insmed is conducting the ENCORE study and is scheduled to meet with the FDA to discuss an accelerated approval based on the positive Phase 3 ARISE trial data[2].

Q: How is Insmed's financial health?

A: As of September 30, 2024, Insmed had approximately $1.5 billion in cash, cash equivalents, and marketable securities, and has renegotiated a term loan to lower its cost of capital[2].

Q: What is the expected timeline for the launch of brensocatib?

A: The NDA submission for brensocatib is on track for the fourth quarter of 2024, with a potential U.S. launch expected in mid-2025[2].

Q: How is Insmed expanding global access to ARIKAYCE?

A: Insmed is increasing global access through compassionate use programs, such as the one in France for the treatment of adult patients with Mycobacterium abscessus lung infection[4].

Sources

1. Insmed Reports Third-Quarter 2024 Financial Results and Provides Business Update - PR Newswire
2. Insmed Reports Third-Quarter 2024 Financial Results and Provides Business Update - Insmed Investor Relations
3. Insmed Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides Business Update - Insmed Investor Relations
4. Insmed Reports First-Quarter 2024 Financial Results and Provides Business Update - Insmed Investor Relations
5. Insmed Reports Second-Quarter 2024 Financial Results and Provides Business Update - Insmed Investor Relations