AZACTAM IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Azactam In Plastic Container, and when can generic versions of Azactam In Plastic Container launch?

Azactam In Plastic Container is a drug marketed by Bristol Myers Squibb and is included in one NDA.

The generic ingredient in AZACTAM IN PLASTIC CONTAINER is aztreonam. Five suppliers are listed for this compound. Additional details are available on the aztreonam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Azactam In Plastic Container

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

Summary for AZACTAM IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for AZACTAM IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol Myers Squibb	AZACTAM IN PLASTIC CONTAINER	aztreonam	INJECTABLE;INJECTION	050632-003	May 24, 1989		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

Investment Scenario and Fundamentals Analysis for AZACTAM in Plastic Container

Last updated: February 16, 2026

Market Overview

AZACTAM (aztreonam) in plastic containers is a broad-spectrum monobactam antibiotic used primarily to treat serious bacterial infections. It is marketed by pharmaceutical companies internationally, often alongside generic options. The global antibiotic market is estimated to reach USD 58 billion by 2025, growing at a CAGR of approximately 3.2% (source: Fortune Business Insights).

Product Positioning and Market Dynamics

AZACTAM's place in the market depends on factors like:

• Medical Indications: Used for pneumonia, urinary tract infections, and sepsis, particularly in patients allergic to penicillin.
• Competitive Landscape: Faces competition from cephalosporins, carbapenems, and other monobactams. Generic versions challenge brand-name pricing.
• Regulatory Environment: US FDA approvals, European Medicines Agency (EMA) protocols, and WHO approvals influence market access.
• Manufacturing and Packaging: Transition to plastic containers reduces packaging costs, improves safety, and enhances stability.

Investment Fundamentals

Aspect	Details
Market Demand	Steady global need driven by hospital demand, especially in intensive care units. Growth in antimicrobial resistance (AMR) management sustains demand.
Pricing and Revenue	AZACTAM’s list price varies but generally ranges from USD 15-25 per vial in North America; annual sales for key players can exceed USD 100 million.
Cost Structure	Manufacturing costs for AZACTAM with plastic containers include API synthesis, formulation, and packaging; cost reduction is achieved through scale and optimized processes.
Patent Status	Patents for AZACTAM expired or are near expiration in major markets, leading to increased generic competition. Patent expiration outlook: 2025-2030.
Regulatory Approvals	Approved in over 50 countries; key markets (US, EU) have stringent requirements favoring validated manufacturing processes.
Supply Chain Dynamics	Monobactam manufacturing involves complex synthesis; supply chain stability impacts pricing and availability.
Market Entry Barriers	Regulatory hurdles, manufacturing complexity, and established competition limit rapid market entry for new entrants.

Growth Drivers and Risks

• Drivers:

  • Rising antimicrobial resistance: Encourages use of antibiotics like AZACTAM.
  • Hospital procurement patterns: Increased hospital procurement contracts favor recurrent demand.
  • Cost advantages of plastic containers: Reduce distribution costs and improve safety profiles, increasing adoption.

• Risks:

  • High generic penetration: Reduces pricing power and margins.
  • Regulatory delays: Impact product launches or conversions to plastic containers.
  • Antimicrobial stewardship programs: Pressure to reduce antibiotic overuse could limit growth.

Financial Outlook

Expected revenue growth aligns with global antibiotic market expansion. Leading producers' sales have grown at 4-6% annually, driven by volume increases rather than price hikes, due to high generic competition.

Strategic Considerations

• Companies considering AZACTAM in plastic containers should target markets with less generic penetration or regulatory barriers.
• Enhancing production efficiency and negotiating procurement agreements can improve margins.
• Investing in formulations that support stability or expand indications offers growth potential.

Key Takeaways

• AZACTAM in plastic containers benefits from hospital demand but faces stiff generic competition post-patent expiry.
• Market growth is driven by antimicrobial resistance and hospital procurement trends.
• Cost reductions via plastic container packaging support competitiveness.
• Regulatory and supply chain considerations remain critical risk factors.
• Investment prospects depend on market share maintenance, potential new indications, and cost management.

FAQs

1. How does patent expiration affect AZACTAM’s market position?

   • Patent expiration increases generic competition, reducing prices and profit margins.

2. What advantages do plastic containers offer for AZACTAM?

   • Cost savings, improved safety, and better stability prolong shelf life and reduce packaging expenses.

3. What are the main competitors to AZACTAM?

   • Cephalosporins, carbapenems, and other monobactams, particularly generics.

4. How significant is the threat from antimicrobial stewardship programs?

   • These programs aim to reduce antibiotic overuse, potentially limiting growth.

5. Which markets offer the most growth opportunities?

   • Emerging markets with increasing hospital infrastructure and lower generic penetration levels.

Citations

[1] Fortune Business Insights, "Global Antibiotic Market Size, Share & Industry Analysis, 2020-2027".