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Last Updated: December 16, 2025

AZACTAM IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Azactam In Plastic Container, and what generic alternatives are available?

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. 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 Azactam In Plastic Container

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

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  • What is the 5 year forecast for AZACTAM IN PLASTIC CONTAINER?
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Summary for AZACTAM IN PLASTIC CONTAINER
Drug patent expirations by year for AZACTAM IN PLASTIC CONTAINER
Recent Clinical Trials for AZACTAM IN PLASTIC CONTAINER

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 1
Eastern Virginia Medical SchoolPhase 2
Virginia Commonwealth UniversityPhase 2

See all AZACTAM IN PLASTIC CONTAINER clinical trials

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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-002 May 24, 1989 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-001 May 24, 1989 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for AZACTAM IN PLASTIC CONTAINER

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Market Dynamics and Financial Trajectory for AZACTAM in Plastic Container

Last updated: August 1, 2025

Introduction

Azactam (aztreonam) represents a cornerstone antibiotic in the treatment of gram-negative bacterial infections, particularly for patients with severe penicillin allergies or resistant strains. The packaging of Azactam in plastic containers signifies modernization efforts, compliance with safety standards, and an expansion in market accessibility. This analysis explores the evolving market landscape, competitive forces, regulatory environment, and financial trajectory underpinning the sale of Azactam in plastic containers.

Market Overview

Global Antibiotics Market

The global antibiotics market was valued at approximately USD 49.2 billion in 2022 and is projected to grow at a CAGR of 3.8% through 2027, driven by rising antimicrobial resistance, increasing infection rates, and expanding healthcare infrastructure across emerging markets [1]. Aztreonam, as a monobactam, accounts for a modest but significant segment, especially given its specificity for gram-negative infections.

Innovation and Packaging Improvements

The shift from traditional glass bottles to plastic containers reflects key industry trends:

  • Enhanced Safety and Sterility: Plastic containers mitigate breakage risks, reducing contamination and safety hazards.
  • Cost-Effectiveness: Plastic packaging decreases manufacturing costs and simplifies logistics.
  • Regulatory Compliance: Modern packaging aligns with stringent safety standards set by agencies like the FDA and EMA.
  • Patient-Centric Delivery: Plastic containers facilitate ease of administration, especially in outpatient or home-care settings.

Market Drivers

  • Antimicrobial Resistance (AMR): Growing AMR drives demand for targeted antibiotics like Azactam, especially as resistance among other classes increases [2].
  • Hospital and Outpatient Pharmacy Demand: Hospitals and clinics prefer single-use, sterile, plastic containers for ease of storage and administration.
  • Expanding End-User Base: Increasing adoption in Asia-Pacific and Latin America due to expanding healthcare infrastructure.

Market Challenges

  • Pricing Pressures: Increasing competition and generic proliferation (once patents expire) pressure pricing.
  • Supply Chain Disruptions: Raw material shortages (e.g., plastics, active pharmaceutical ingredients) impact production stability.
  • Regulatory Complexities: Variations across regions complicate distribution and packaging modifications.

Competitive Landscape

Key Players

Manufacturers such as Pfizer (original developer), Sandoz, and local producers in emerging markets dominate the aztreonam market [3]. Packaging diversification, including the adoption of plastic containers, is part of strategic differentiation.

Packaging Innovations

Companies like Pfizer have introduced pre-filled, ready-to-use plastic syringes and vials, streamlining drug delivery [4]. The transition to plastic containers enhances compliance with safety standards and reduces preparation time.

Market Share and Revenue Trends

While precise sales figures for Azactam in plastic containers are proprietary, overall antibiotic segment revenues from sterile injectable formulations in plastic packaging are growing approximately 5-7% annually [5].

Regulatory Environment

  • FDA and EMA Guidelines: Focus on sterile manufacturing practices, packaging integrity, and safety.
  • Environmental Regulations: Increasing emphasis on sustainable packaging options influences industry choices.
  • Post-Market Surveillance: Ensures ongoing safety and efficacy, impacting packaging standards.

Financial Trajectory

Revenue Projections

The industry anticipates a compounded annual growth rate (CAGR) of 4%-6% in the injectable antibiotics sector through 2027, with Azactam's share likely expanding modestly due to its niche role in gram-negative infection management.

Pricing and Reimbursement Dynamics

Insurance coverage, government procurement strategies, and hospital budgets heavily influence pricing strategies. In mature markets, generic Azactam (in plastic containers) faces price erosion, whereas branded formulations retain premium pricing in emerging markets.

Cost Considerations

  • Manufacturing Costs: Plastic packaging reduces per-unit costs by approximately 10-15% compared to glass.
  • R&D and Regulatory Compliance: Significant investments for ensuring packaging safety and stability.
  • Distribution and Logistics: Plastic containers decrease transportation costs owing to reduced breakage and easier handling.

Market Penetration and Sales Growth

Enhanced packaging facilitates market penetration, especially in outpatient departments and home-care markets. Strategic partnerships with healthcare providers can accelerate sales growth.

Risk Factors

  • Supply chain uncertainties, raw material costs, and regulatory delays can hamper financial growth.
  • Competitive pressures from emerging generics and biosimilars may lead to pricing declines.

Future Outlook

The trajectory for Azactam in plastic containers remains positive, supported by industry trends emphasizing safety, cost-efficiency, and compliance. Innovations such as pre-filled syringes and single-dose units are expected to further boost adoption. Market resilience will rely on ongoing antimicrobial stewardship, regulatory alignment, and supply chain optimization.

Key Takeaways

  • The switch to plastic containers enhances Azactam’s marketability through safety improvements and logistical efficiencies.
  • Global antibiotic demand driven by rising AMR and expanding healthcare infrastructure underpins positive revenue momentum.
  • Competitive pressures and regulatory compliance remain pivotal, influencing pricing, packaging innovation, and distribution strategies.
  • Manufacturing and logistics cost benefits of plastic packaging bolster profit margins, although supply chain risks persist.
  • Strategic investments in packaging technology and regional market expansion could significantly enhance Azactam’s financial trajectory.

FAQs

Q1: How does packaging in plastic containers influence Azactam’s market competitiveness?
A1: Plastic containers improve safety, ease of use, and logistical efficiency, making Azactam more attractive to healthcare providers and patients, thus boosting market share.

Q2: What are the main drivers behind the growth of Azactam in plastic containers?
A2: The primary drivers include regulatory compliance, safety standards, cost-effectiveness, and rising demand for targeted antibiotics amidst growing antimicrobial resistance.

Q3: How does antimicrobial resistance impact the financial prospects of Azactam?
A3: Increased resistance elevates demand for effective agents like Azactam, potentially expanding sales and revenue, especially in hospital settings.

Q4: What risks could hamper the financial growth of Azactam packaged in plastic?
A4: Supply chain disruptions, pricing pressures from generics, and regulatory hurdles could negatively impact profitability and market expansion.

Q5: What strategic moves could maximize Azactam’s market potential?
A5: Investing in innovative packaging formats, expanding into emerging markets, and strengthening supply chain resilience are key strategies.


References

[1] MarketsandMarkets. "Antibiotics Market by Product, Application, and Region - Global Forecast to 2027".
[2] WHO. "Antimicrobial Resistance Global Report". 2022.
[3] IQVIA. "Global Pharmaceutical Market Analysis 2022".
[4] Pfizer Inc. "Product Packaging Innovation Reports". 2021.
[5] EvaluatePharma. "Sterile Injectable Antibiotics Market Trends". 2022.

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