CAYSTON Drug Patent Profile

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

Cayston is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in CAYSTON is aztreonam. There are eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the aztreonam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cayston

A generic version of CAYSTON was approved as aztreonam by FRESENIUS KABI USA on June 18^th, 2010.

Summary for CAYSTON

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	6
Patent Applications:	7,878
Drug Prices:	Drug price information for CAYSTON
What excipients (inactive ingredients) are in CAYSTON?	CAYSTON excipients list
DailyMed Link:	CAYSTON at DailyMed

See drug prices for CAYSTON

Recent Clinical Trials for CAYSTON

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

Sponsor	Phase
University of Dundee	Phase 2
Gilead Sciences	Phase 2
Children's Hospital & Research Center Oakland	Phase 4

See all CAYSTON clinical trials

US Patents and Regulatory Information for CAYSTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010		RX	Yes	Yes

Expired US Patents for CAYSTON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010

EU/EMA Drug Approvals for CAYSTON

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Cayston	aztreonam	EMEA/H/C/000996 Cayston is indicated for the suppressive therapy of chronic pulmonary infections due to Pseudomonas aeruginosa in patients with cystic fibrosis (CF) aged 6 years and older.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2009-09-21

International Patents for CAYSTON

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

Country	Patent Number	Title	Estimated Expiration
Canada	2708703	AZTREONAM INHALABLE DESTINE AU TRAITEMENT ET A LA PREVENTION D'INFECTIONS BACTERIENNES PULMONAIRES (INHALABLE AZTREONAM FOR TREATMENT AND PREVENTION OF PULMONARY BACTERIAL INFECTIONS)
Israel	156596	INHALABLE AZTREONAM FOR USE IN THE TREATMENT OF PULMONARY INFECTIONS CAUSED BY GRAM NEGATIVE BACTERIA AND FORMULATIONS AND PRODUCTS COMPRISING THE SAME
Japan	2004516302
Poland	2158901

Supplementary Protection Certificates for CAYSTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1353647	300492	Netherlands		PRODUCT NAME: AZTREONAMLYSINE; REGISTRATION NO/DATE: EU/1/09/543/001 20090923
1353647	27/2011	Austria		PRODUCT NAME: AZTREONAMLYSIN; REGISTRATION NO/DATE: EU/1/09/543/001 20090921
1353647	CA 2011 00021	Denmark
1353647	91851	Luxembourg		91851, EXPIRES: 20240921

Market Dynamics and Financial Trajectory for CAYSTON

Last updated: December 16, 2024

Introduction to CAYSTON

CAYSTON (aztreonam for inhalation solution) is a prescription medication used to treat bacterial infections in the lungs of patients with cystic fibrosis. It is part of the broader cystic fibrosis drugs market, which includes various drug classes such as anti-infectives, CFTR modulators, mucolytic agents, and more.

Market Segmentation and Positioning

CAYSTON falls under the anti-infectives category within the cystic fibrosis drugs market. This segment includes other notable drugs like Tobi Podhaler (tobramycin inhalation powder) and Arikayce (amikacin liposome inhalation suspension)[1].

Competitive Landscape

In the competitive landscape, CAYSTON is often compared to other anti-infective drugs, particularly Tobramycin Inhalation Solution (TOBI). Studies have shown that CAYSTON can offer superior or non-inferior outcomes in terms of lung function improvement compared to TOBI. For instance, an active comparator study revealed that patients taking CAYSTON had a 2.70% higher average change in FEV1% predicted compared to those taking TOBI over three treatment cycles[4].

Financial Performance

Revenue Contribution

CAYSTON is one of the products within Gilead Sciences' diverse portfolio. While specific revenue figures for CAYSTON alone are not always detailed in Gilead's financial reports, it is included in the broader category of "Other product sales" which also includes other medications like AmBisome, Jyseleca, Letairis, Ranexa, and Zydelig.

In the second quarter of 2021, Gilead's "Other product sales" category, which includes CAYSTON, increased by 7% to $498 million compared to the same period in 2020. However, for the full year 2020, this category saw an 18% decline to $1.9 billion, primarily due to generic entries affecting other products in this segment[2].

Recent Trends

In recent quarters, Gilead's overall product sales have been influenced by various factors, including the impact of COVID-19 on different product lines. While Veklury (remdesivir) sales have been significant, other products like CAYSTON have contributed to the stability and growth in other therapeutic areas. For example, in the Q2 2024 report, Gilead noted growth across HIV, liver disease, and oncology, which indirectly supports the financial trajectory of products like CAYSTON[3].

Regulatory and Pipeline Overview

Regulatory Approvals

CAYSTON has received regulatory approvals from key health authorities, including the FDA. The drug's inclusion in various treatment guidelines for cystic fibrosis patients underscores its regulatory acceptance and market viability.

Pipeline Analysis

While CAYSTON itself is not in the pipeline phase, the broader cystic fibrosis drugs market is dynamic, with ongoing research and development in new treatments. Phase 1, 2, and 3 drugs in the pipeline could potentially impact the market share of existing drugs like CAYSTON. However, given its established position and clinical efficacy, CAYSTON is likely to remain a significant player in the anti-infectives segment[1].

Market Growth and Forecast

Global Market Size and Growth

The global cystic fibrosis drugs market is expected to grow, driven by advancements in treatment options and increasing awareness of cystic fibrosis. The market is forecasted to expand from 2024 to 2031, with CAYSTON contributing to this growth as part of the anti-infectives segment[1].

Geographic Segmentation

The market for cystic fibrosis drugs, including CAYSTON, is segmented geographically into North America, Europe, Asia Pacific, Latin America, and the Rest of the World. North America and Europe are significant markets due to higher prevalence rates and better healthcare infrastructure. However, emerging markets in Asia Pacific and Latin America are also expected to contribute to the growth of CAYSTON and other cystic fibrosis drugs[1].

Company Profiles and Strategies

Gilead Sciences Overview

Gilead Sciences, the manufacturer of CAYSTON, is a major pharmaceutical company with a diverse product portfolio. The company's financial performance is influenced by its entire range of products, but CAYSTON remains an important part of its respiratory and infectious disease segment.

Financial Snapshot

Gilead's financial reports highlight the company's overall performance, with total product sales excluding Veklury showing growth trends. For instance, in Q2 2024, product sales excluding Veklury increased by 6% year-over-year, reflecting growth across various therapeutic areas, including those where CAYSTON is positioned[3].

Business Strategies

Gilead's business strategies include continued investment in research and development, strategic acquisitions, and expansion into new markets. These strategies are likely to support the continued market presence and growth of CAYSTON.

Clinical Efficacy and Patient Outcomes

Active Comparator Study

The active comparator study comparing CAYSTON to TOBI demonstrated that CAYSTON can offer superior lung function improvements. This study showed that patients taking CAYSTON had a higher average change in FEV1% predicted compared to those taking TOBI, highlighting the clinical efficacy of CAYSTON[4].

Side Effects and Safety Profile

While CAYSTON has shown favorable outcomes, it also comes with potential side effects. Common side effects include cough and productive cough, with serious adverse events reported in a smaller percentage of patients[4].

Market Challenges and Opportunities

Competitive Challenges

The anti-infectives segment of the cystic fibrosis drugs market is competitive, with drugs like TOBI and Arikayce vying for market share. However, CAYSTON's clinical efficacy and patient satisfaction data position it strongly in this market.

Opportunities for Growth

The increasing awareness of cystic fibrosis and advancements in treatment options present opportunities for growth. Expanding into emerging markets and continuing to invest in research and development can further enhance CAYSTON's market position.

Key Takeaways

• Market Position: CAYSTON is a significant player in the anti-infectives segment of the cystic fibrosis drugs market.
• Financial Performance: Part of Gilead Sciences' broader product portfolio, CAYSTON contributes to the company's overall financial health.
• Clinical Efficacy: CAYSTON has demonstrated superior or non-inferior outcomes compared to other anti-infective drugs like TOBI.
• Market Growth: The global cystic fibrosis drugs market is expected to grow, with CAYSTON contributing to this expansion.
• Challenges and Opportunities: While facing competitive challenges, CAYSTON has opportunities for growth in emerging markets and through continued R&D investment.

FAQs

What is CAYSTON used for?

CAYSTON (aztreonam for inhalation solution) is used to treat bacterial infections in the lungs of patients with cystic fibrosis.

How does CAYSTON compare to TOBI?

CAYSTON has shown superior or non-inferior outcomes in lung function improvement compared to TOBI in clinical studies.

What are the common side effects of CAYSTON?

Common side effects include cough and productive cough, with serious adverse events reported in a smaller percentage of patients.

Who manufactures CAYSTON?

CAYSTON is manufactured by Gilead Sciences.

What is the forecasted growth for the cystic fibrosis drugs market?

The global cystic fibrosis drugs market is expected to grow from 2024 to 2031, driven by advancements in treatment options and increasing awareness of cystic fibrosis.

Sources

1. iHealthcareAnalyst: Cystic Fibrosis Drugs Market and Forecast 2024-2031
2. Gilead Sciences: Gilead Sciences Announces Fourth Quarter and Full Year 2020 Financial Results
3. Gilead Sciences: Q224 Yr/Yr Qtr/Qtr Management Commentary
4. CAYSTON: Active Comparator Study | CAYSTON® (aztreonam for inhalation solution)