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. Five 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:	5
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	67
Patent Applications:	7,419
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
Uppsala University	PHASE4
Uppsala Clinical Research Center, Sweden	PHASE4
The Swedish Research Council	PHASE4

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
Fresenius Kabi Usa	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065439-003	Jun 18, 2010	AP	RX	No	No
Hikma	AZTREONAM	aztreonam	INJECTABLE;INJECTION	065286-001	Mar 23, 2011		DISCN	No	No
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-002	May 24, 1989		DISCN	Yes	No
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-001	May 24, 1989		DISCN	Yes	No
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-003	May 24, 1989		DISCN	No	No

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	7,208,141
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010	8,399,496
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010	7,427,633
Gilead	CAYSTON	aztreonam	FOR SOLUTION;INHALATION	050814-001	Feb 22, 2010	7,214,364

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/000996Cayston 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Aztreonam

Last updated: September 4, 2025

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Introduction

Aztreonam is a monobactam antibiotic introduced in the pharmaceutical market primarily for managing severe bacterial infections caused by Gram-negative pathogens. Its unique mechanism, resistance profile, and clinical applications make it a pivotal player within the antibiotic segment. This analysis examines the evolving market landscape, key drivers, challenges, and the financial trajectory shaping aztreonam’s future prospects.

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Market Overview and Pharmacological Profile

Aztreonam, marketed predominantly under the brand names like Azactam (U.S.), is administered intravenously or intramuscularly to treat complicated urinary tract infections, lower respiratory tract infections, and sepsis. Its efficacy against multidrug-resistant Gram-negative bacteria, such as Pseudomonas aeruginosa, positions it as a crucial therapeutic in hospital settings.

Developed in the 1980s, aztreonam’s pharmacological profile is distinguished by its selective inhibition of bacterial cell wall synthesis, with minimal activity against Gram-positive bacteria or anaerobes. Its stability against many beta-lactamases, especially in the context of rising antibiotic resistance, enhances its clinical value.

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Market Dynamics

1. Growing Antibiotic Resistance and Unmet Medical Need

The escalation of multidrug-resistant Gram-negative bacteria has pushed healthcare providers to seek effective, targeted antimicrobial agents. According to the CDC, antimicrobial resistance in Gram-negative bacteria like Pseudomonas aeruginosa has increased steadily, limiting treatment options and fueling demand for drugs like aztreonam that can bridge this gap [1].

2. Clinical Adoption and Therapeutic Positioning

Aztreonam’s role is increasingly recognized in combination therapies, especially for patients with penicillin allergies, since it offers a beta-lactam alternative. Its primary utilization remains within hospital settings, especially intensive care units (ICUs), where resistant infections are prevalent. However, the advent of new antibiotics with broader spectrums and improved pharmacokinetics has posed some competitive challenges.

3. Pipeline Expansion and Formulation Innovations

Despite its proven track record, aztreonam has seen limited innovation in recent years. However, recent research has focused on developing inhaled formulations (e.g., aztreonam lysine for cystic fibrosis-related infections), expanding its scope into respiratory indications. The ongoing development of aztreonam composites and combination agents (e.g., aztreonam/avibactam) for resistant bacterial strains signifies a potential boost in market size [2].

4. Competitive Landscape

Aztreonam faces competition from other beta-lactams, carbapenems, cephalosporins, and novel agents like plazomicin and cefiderocol, which offer broader activity against resistant bacteria. Biosimilar versions, once approved, could further influence market prices and access, compelling incumbent players to innovate or differentiate.

5. Regulatory and Commercial Challenges

Regulatory pathways remain robust, with off-label use and expanding indications requiring careful maneuvering. The drug’s limited oral formulation restricts outpatient use, confining sales primarily to inpatient care. Price pressures, reimbursement policies, and antimicrobial stewardship programs also modulate market growth.

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Financial Trajectory

1. Revenue Trends and Market Penetration

Global sales of aztreonam had plateaued historically but have recently exhibited modest growth driven by increased resistance-driven prescriptions and formulation advancements. The drug’s peak revenues are primarily derived from developed markets like the U.S. and Europe, where hospital procurement dictates sales.

2. Impact of New Formulations and Combinations

Inhaled aztreonam formulations have contributed to revenue diversification, particularly for cystic fibrosis treatments. Moreover, the exploration of combination agents (e.g., aztreonam/avibactam), if successfully commercialized, could unlock new markets, including combating certain multidrug-resistant infections.

3. Patent Landscape and Generic Competition

While aztreonam was patented in the 1980s, generic versions entered the market in the subsequent decades. Patent expirations have led to pricing pressures but also increased accessibility, especially in lower-income regions. The introduction of newer formulations or combinations may be subject to patent litigations, affecting proprietary exclusivity.

4. R&D Investment and Future Outlook

Limited R&D activity in the aztreonam space is observed relative to other antibiotics, reflecting challenges in innovation due to scientific complexity and regulatory hurdles. Nonetheless, targeted investments in inhaled formulations and resistant-pathogen-specific combinations are anticipated to bolster revenue streams in the coming years.

5. Market Risks and Opportunities

Risks include emerging resistance reducing drug efficacy, competition from newer antibiotics, and regulatory hurdles. Conversely, the rising global burden of resistant infections and increasing clinical adoption of aztreonam–based therapies present lucrative opportunities to expand its financial footprint.

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Market Drivers and Barriers

Drivers:

• Increasing prevalence of multidrug-resistant Gram-negative bacteria.
• Limited treatment alternatives for specific resistant pathogens.
• Therapeutic niche for aztreonam combination therapies and inhaled formulations.
• Growing global focus on antibiotic stewardship and infection control.

Barriers:

• Competition from newer antibiotics with broader spectrum.
• Limited oral formulations restricting outpatient use.
• Price pressures and government healthcare policies.
• Scientific challenges in developing novel formulations or combination agents.

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Strategic Implications

For stakeholders—pharmaceutical companies, investors, and healthcare providers—understanding aztreonam’s market trajectory underscores the importance of innovation. Developing inhaled delivery systems, combination therapies, and rapid diagnostic tools to identify eligible patients could significantly enhance market penetration. Furthermore, forging strategic collaborations with biotech firms focusing on resistant bacteria could accelerate pipeline advancement and revenue growth.

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Key Takeaways

• Growing Resistance: The escalation of Gram-negative pathogen resistance drives sustained demand for aztreonam, especially in hospital settings.
• Innovation is Crucial: Formulation advancements, particularly inhaled versions and combination agents, are pivotal for expanding its therapeutic scope.
• Market Competition: The emergence of newer antibiotics and biosimilars poses competitive pressures, necessitating strategic differentiation.
• Revenue Growth Potential: Despite generic competition, targeted applications in resistant infections and niche indications support a positive financial trajectory.
• Regulatory Dynamics: Navigating approval pathways for new formulations and combination therapies can significantly influence market expansion.

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FAQs

Q1: What makes aztreonam effective against resistant bacterial strains?
A: Its unique monobactam structure confers stability against many beta-lactamases, making it effective against certain resistant Gram-negative bacteria like Pseudomonas aeruginosa.

Q2: Are there oral formulations of aztreonam?
A: Currently, aztreonam is available only as an intravenous or intramuscular injection, limiting outpatient and oral use.

Q3: How does aztreonam compare to other antibiotics for resistant infections?
A: Aztreonam offers a targeted option primarily against Gram-negative pathogens resistant to other beta-lactams, especially in patients allergic to penicillin.

Q4: What are recent pipeline developments for aztreonam?
A: Recent efforts focus on inhaled formulations for cystic fibrosis and combination agents like aztreonam/avibactam to combat multidrug-resistant bacteria.

Q5: What are the main factors influencing aztreonam sales globally?
A: Resistance prevalence, clinical adoption in hospitals, formulation innovations, regulatory approvals, and competitive dynamics are key factors.

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References

[1] Centers for Disease Control and Prevention (CDC). "Antimicrobial Resistance Threats in the United States, 2019."
[2] ClinicalTrials.gov. "Studies investigating aztreonam formulations and combinations."