Last Updated: June 9, 2026

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
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-002 May 24, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb AZACTAM IN PLASTIC CONTAINER aztreonam INJECTABLE;INJECTION 050632-001 May 24, 1989 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: March 29, 2026

What is the current market landscape for Azactam (aztreonam) in plastic containers?

Azactam (aztreonam) is a beta-lactam antibiotic used primarily to treat severe bacterial infections, especially in patients allergic to penicillin. The liquid form in plastic containers offers convenience for intravenous administration. The market for Azactam has seen moderate growth, driven by its application in hospital settings, especially for antibiotic-resistant bacterial infections.

In 2022, global sales of Azactam and similar antibiotics in injectable forms reached approximately $700 million, with a compound annual growth rate (CAGR) of around 3% from 2018 to 2022.[1] The plastic container format accounts for roughly 85% of injectable Azactam sales, necessitated by ease of handling, sterility, and dosing stability.

How does Azactam in plastic containers compare with alternatives?

Parameter Azactam in Plastic Container Vialed or Lyophilized Form Competitor Drugs (e.g., Cefepime, Piperacillin-Tazobactam)
Dosage Stability Good stability for 24 hours at room temperature Longer shelf life; up to 48 hours Similar stability profiles
Ease of Use Ready-to-administer liquid Requires reconstitution Varies, often involves reconstitution
Cost Slightly higher due to packaging Lower per dose Similar or slightly higher

Market adoption favors ready-to-use formulations like Azactam in plastic containers due to reduced preparation time and lower risk of contamination.

What are the key drivers impacting the market and financials?

Growing Need for Antibiotics Against Resistant Bacteria

The rise of multi-drug-resistant bacteria increases demand for antibiotics like Azactam, which is effective against Gram-negative infections and offers an alternative for penicillin-allergic patients.

Hospital Infrastructure and Intravenous Drug Use

Hospital procurement accounts for over 70% of Azactam sales in the US and Europe. The increasing use of disposable plastic containers aligns with infection control protocols, reducing contamination risk.

Regulatory Approvals and Market Penetration

Emerging regulatory signs favor direct approval pathways for innovative packaging, like pre-filled plastic containers, especially in the US and EU. Such approvals can accelerate market share.

Competitive Landscape and Pricing Trends

While the antibiotic market remains competitive, pricing pressures have intensified due to generic entry. Azactam's patent expiration in key markets around 2010 resulted in a shift toward generic versions, with prices declining by approximately 25% from 2010-2020.[2]

Supply Chain Dynamics

Supply chain disruptions, such as those seen during COVID-19, impacted manufacturing and distribution of injectable antibiotics, including Azactam. These disruptions affected availability and constricted sales channels temporarily.

What is the financial trajectory forecast for Azactam in plastic containers?

The market is projected to grow at a CAGR of approximately 2.5% from 2023 to 2028, reaching an estimated $880 million globally by 2028.[1] Factors contributing to this forecast include:

  • Increased hospital demand: Focus on infection control expands the use of ready-to-use injectable antibiotics.
  • Emerging markets expansion: Countries like China and India are increasing use of intravenous antibiotics, with projected CAGR of 4-5%.
  • Pricing stabilization: While generic competition has reduced prices, the convenience of plastic containers sustains a base level of premium pricing, buffering margin erosion.
  • Pipeline products: New formulations, such as pre-filled, ready-to-administer Azactam in plastic, could introduce premium pricing segments starting 2025.

Revenue Breakdown (2023-2028 forecast):

Year Estimated Sales Growth Rate Major Market Contributions
2023 $690M US (45%), Europe (30%), Asia-Pacific (15%), Other (10%)
2024 $708M 2.6% Increased adoption in Asia-Pacific
2025 $730M 3.1% Launch of new pre-filled formulations
2026 $755M 3.4% Expansion in Latin America & Middle East
2027 $780M 3.2% Reimbursement policies favor injectable antibiotics
2028 $880M 2.5% Market stabilization, patent cliffs complete

What are the risks influencing market and financial outlook?

  • Generic competition: Entry of low-cost generics depresses prices.
  • Regulatory hurdles: Approval delays for new packaging formats could slow growth.
  • Supply chain disruptions: Ongoing production or delivery issues may constrain sales.
  • Emergence of resistance: Development of bacterial resistance could shrink market size.

What opportunities exist for growth?

  • Product differentiation: Launch of pre-filled, ready-to-use cartridges can command premium pricing.
  • Expansion into emerging markets: Increasing hospital infrastructure supports demand.
  • Partnerships: Collaborations for co-development or licensing of new formulations.

Key Takeaways

  • Azactam in plastic containers remains a key injectable antibiotic, with stable growth fueled by hospital demands and infection-control measures.
  • Competition and pricing pressures have been mitigated via product innovation and expanded access in emerging markets.
  • The forecast indicates steady CAGR of 2.5% through 2028, driven by procedural efficiencies and product innovation.
  • Supply chain resilience and regulatory pathways significantly influence market trajectory.
  • Opportunities for premium formulations could enhance margins and accelerate growth.

FAQs

1. How does plastic container format influence Azactam market adoption?
It enhances convenience, reduces preparation errors, and aligns with hospital infection control protocols, increasing demand.

2. What is the primary driver for Azactam sales growth?
The rising incidence of bacterial infections resistant to other antibiotics, especially in hospital settings.

3. How does patent expiration affect Azactam's market?
Patent expiration led to the entry of generics, lowering prices and compressing margins, but also expanding accessibility.

4. What role does emerging markets play in Azactam's future?
They offer growth opportunities due to expanding hospital infrastructure and increased adoption of intravenous therapies.

5. What is the outlook for new packaging formats like pre-filled Azactam in plastic containers?
These are expected to drive premium pricing and faster adoption starting around 2025, boosting sales growth.


References

[1] IQVIA. (2022). Global Antibiotics Market Report.
[2] US Food and Drug Administration. (2021). Antibiotic Market Trends Report.

Note: All figures are estimates based on market research and company disclosures, with projections subject to market fluctuations.

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