AZTREONAM - Generic Drug Details

What are the generic sources for aztreonam and what is the scope of freedom to operate?

Aztreonam is the generic ingredient in four branded drugs marketed by Gilead, Bristol Myers Squibb, Fresenius Kabi Usa, Hikma, and Hospira, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for aztreonam. Four suppliers are listed for this compound.

Summary for AZTREONAM

US Patents:	0
Tradenames:	4
Applicants:	5
NDAs:	6
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	111
Clinical Trials:	62
Patent Applications:	7,444
Drug Prices:	Drug price trends for AZTREONAM
What excipients (inactive ingredients) are in AZTREONAM?	AZTREONAM excipients list
DailyMed Link:	AZTREONAM at DailyMed

See drug prices for AZTREONAM

Recent Clinical Trials for AZTREONAM

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

Sponsor	Phase
Meiji Seika Pharma Co., Ltd.	Phase 3
National Cancer Institute (NCI)	Phase 1
Qianfoshan Hospital	N/A

See all AZTREONAM clinical trials

Pharmacology for AZTREONAM

Drug Class

Monobactam Antibacterial

Medical Subject Heading (MeSH) Categories for AZTREONAM

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for AZTREONAM

J01DF	Monobactams
J01D	OTHER BETA-LACTAM ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for AZTREONAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	AZTREONAM	aztreonam	INJECTABLE;INJECTION	206517-002	Nov 8, 2021	AP	RX	No	No
Bristol Myers Squibb	AZACTAM	aztreonam	INJECTABLE;INJECTION	050580-001	Dec 31, 1986		DISCN	No	No
Hospira	AZTREONAM	aztreonam	INJECTABLE;INJECTION	206517-001	Nov 8, 2021	AP	RX	No	No
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-003	May 24, 1989		DISCN	No	No
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010		RX	Yes	Yes

Expired US Patents for AZTREONAM

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 AZTREONAM

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

AZTREONAM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Aztreonam

Market Size and Growth Projections

The aztreonam market is poised for significant growth, driven by several key factors. As of 2023, the market size was valued at USD 1.5 billion and is projected to reach USD 2.42 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6% from 2024 to 2031[1][4].

Key Drivers of Market Growth

Increasing Incidence of Gram-Negative Bacterial Infections

The rising incidence of gram-negative bacterial infections, particularly those resistant to multiple antibiotics, is a major driver of the aztreonam market. Aztreonam's efficacy against these pathogens, including Pseudomonas aeruginosa and Enterobacteriaceae, makes it a critical treatment option[1][4].

Antibiotic Resistance and Healthcare Infrastructure

The growing problem of antibiotic resistance and the expansion of healthcare infrastructure globally are fueling the demand for effective antibiotics like aztreonam. This is especially true in hospital settings where aztreonam is increasingly used to treat serious and multidrug-resistant infections[1][4].

Research and Development

Continuous research and development efforts aimed at exploring new formulations and combination therapies involving aztreonam are also driving market growth. For example, the combination of aztreonam with avibactam (ATM-AVI) has shown promising results in treating infections caused by metallo-β-lactamase (MBL)-producing multidrug-resistant pathogens[2][5].

Geographical Market Dynamics

North America

North America dominates the aztreonam market due to advanced healthcare facilities, a high prevalence of antibiotic-resistant infections, and robust regulatory oversight facilitating drug approvals and market access[4].

Europe

Europe follows closely, driven by stringent infection control measures in healthcare settings and increasing incidences of multidrug-resistant infections. The European Medicines Agency's approval of aztreonam-avibactam in April further supports this market[4][5].

Asia-Pacific and Latin America

The Asia-Pacific region and Latin America are emerging as significant markets due to rapid urbanization, improving healthcare infrastructure, and rising healthcare expenditure. Countries like China and India are witnessing increased adoption of aztreonam in both hospital and community settings[4].

Middle East & Africa

In the Middle East and Africa, market growth is influenced by efforts to combat infectious diseases and improve healthcare outcomes, supported by healthcare infrastructure development and increasing awareness among healthcare providers[4].

Financial Trajectory and Cost Considerations

Revenue and Cost Per Patient

The revenue cost per patient for aztreonam can vary significantly based on the treatment regimen. For instance, the cost per patient for continuous aztreonam treatment can range from £13,092 to £26,184 per year, depending on whether alternative antibiotics are used in off-cycle months[3].

Market Restraints: Patent Expirations and Generics

The financial trajectory of aztreonam is also influenced by market restraints such as patent expirations and the availability of generic versions. While the patent for aztreonam lysine is not due to expire until after the considered time period, the eventual entry of generics could lead to price erosion and reduced profitability for branded formulations[4].

Combination Therapies and Future Outlook

Aztreonam-Avibactam Combination

The aztreonam-avibactam combination has shown promising results in clinical trials, offering a new therapeutic option for patients with serious gram-negative bacterial infections. This combination restores aztreonam's activity against bacteria that carry metallo-β-lactamase and beta-lactamase enzymes, which confer resistance to nearly all currently available antibiotics[2][5].

Future Market Opportunities

The future outlook for the aztreonam market is positive, driven by ongoing research and development, increasing healthcare investments, and the persistent challenge of antibiotic-resistant infections globally. Key trends include the expansion in emerging markets, the development of new combination therapies, and a focus on hospital-acquired infections (HAIs)[4].

Competitive Analysis

The aztreonam market is competitive, with both branded pharmaceutical companies and generic manufacturers playing significant roles. Branded companies like Pfizer focus on innovation through new formulations and combination therapies to maintain market leadership, while generic manufacturers intensify competition post-patent expiry, leading to price competition and market consolidation[4].

Regulatory and Safety Considerations

Regulatory Approvals and Safety Profile

Aztreonam-avibactam has received regulatory approvals based on positive phase 3 clinical trial results. The safety profile of this combination is generally well-tolerated, with adverse event patterns consistent with those of aztreonam alone. However, stringent regulatory requirements and the need for extensive clinical trials can prolong time-to-market and increase development costs[2][5].

Key Takeaways

• Growing Demand: Aztreonam's market is driven by the increasing incidence of gram-negative bacterial infections and the need for effective antibiotics.
• Geographical Expansion: The market is expanding in North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.
• Combination Therapies: The aztreonam-avibactam combination is a significant development in treating multidrug-resistant infections.
• Financial Considerations: The market is influenced by patent expirations, generic competition, and varying cost per patient based on treatment regimens.
• Future Outlook: The market is expected to grow positively, driven by ongoing R&D and increasing healthcare investments.

FAQs

1. What is the current market size of aztreonam and its projected growth?

   • The aztreonam market was valued at USD 1.5 billion in 2023 and is expected to reach USD 2.42 billion by 2031, growing at a 6% CAGR from 2024 to 2031[1].

2. What are the primary drivers of the aztreonam market?

   • The primary drivers include the increasing incidence of gram-negative bacterial infections, antibiotic resistance, and the expansion of healthcare infrastructure[1][4].

3. What is the significance of the aztreonam-avibactam combination?

   • The aztreonam-avibactam combination restores aztreonam's activity against bacteria that carry metallo-β-lactamase and beta-lactamase enzymes, offering a new therapeutic option for multidrug-resistant infections[2][5].

4. How does the geographical distribution affect the aztreonam market?

   • The market is dominated by North America and Europe, with significant growth opportunities in the Asia-Pacific, Latin America, and Middle East & Africa regions[4].

5. What are the potential restraints on the aztreonam market?

   • Market restraints include competition from generics, continued emergence of antibiotic-resistant strains, stringent regulatory requirements, and safety concerns[4].

Cited Sources

1. Market Research Intellect - Aztreonam Market Size, Growth, Share | Analysis by 2031
2. Pfizer - Phase 3 Studies of Pfizer's Novel Antibiotic Combination Offer New ...
3. NHS England - DRAFT FOR PUBLIC CONSULTATION ONLY
4. Data Horizon Research - Aztreonam Market Size, Growth and Analysis Report - 2033
5. CIDRAP - Phase 3 data support use of combination antibiotic for multidrug-resistant