CEFTAZIDIME SODIUM IN PLASTIC CONTAINER Drug Patent Profile

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

Ceftazidime Sodium In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in CEFTAZIDIME SODIUM IN PLASTIC CONTAINER is ceftazidime sodium. There are seventeen drug master file entries for this compound. Additional details are available on the ceftazidime sodium profile page.

Summary for CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	7
Patent Applications:	99
DailyMed Link:	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER at DailyMed

Recent Clinical Trials for CEFTAZIDIME SODIUM IN PLASTIC CONTAINER

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

Sponsor	Phase
Qilu Pharmaceutical Co., Ltd.	PHASE3
Ain Shams University	PHASE2
Arrevus Inc.	Phase 2

See all CEFTAZIDIME SODIUM IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for CEFTAZIDIME SODIUM 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
Baxter Hlthcare	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER	ceftazidime sodium	INJECTABLE;INJECTION	063221-001	Apr 29, 1993		DISCN	No	No
Baxter Hlthcare	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER	ceftazidime sodium	INJECTABLE;INJECTION	063221-002	Apr 29, 1993		DISCN	No	No
Baxter Hlthcare	CEFTAZIDIME SODIUM IN PLASTIC CONTAINER	ceftazidime sodium	INJECTABLE;INJECTION	063221-003	Apr 29, 1993		DISCN	No	No

CEFTAZIDIME SODIUM IN PLASTIC CONTAINER: MARKET DYNAMICS AND FINANCIAL TRAJECTORY

Last updated: February 19, 2026

Ceftazidime sodium, a third-generation cephalosporin antibiotic, is delivered in a plastic container system. This formulation targets a range of serious bacterial infections, primarily in hospital settings. The market for this product is influenced by antibiotic resistance trends, the availability of generic alternatives, and evolving healthcare procurement policies. Financial performance is tied to prescription volumes, pricing strategies, and manufacturing costs.

WHAT IS CEFTAZIDIME SODIUM AND ITS PRIMARY APPLICATIONS?

Ceftazidime sodium is an injectable antibiotic that combats a broad spectrum of gram-negative and gram-positive bacteria. Its efficacy extends to pathogens commonly found in healthcare-associated infections, including pneumonia, urinary tract infections, and skin and soft tissue infections [1]. The plastic container delivery system is designed for ease of use in clinical environments, offering a ready-to-use solution that minimizes preparation time and reduces the risk of contamination compared to traditional vial-and-syringe methods.

The mechanism of action for ceftazidime involves inhibiting bacterial cell wall synthesis by binding to penicillin-binding proteins. This disruption leads to bacterial lysis and death. Its pharmacokinetic profile allows for good tissue penetration and a favorable half-life, supporting once or twice-daily dosing regimens [2].

Key applications include:

• Nosocomial Pneumonia: Particularly effective against Pseudomonas aeruginosa, a common cause of hospital-acquired pneumonia.
• Complicated Urinary Tract Infections: Addresses infections caused by resistant gram-negative organisms.
• Skin and Soft Tissue Infections: Treats severe infections requiring systemic antibiotic therapy.
• Bone and Joint Infections: Used in combination with other agents for complex infections.
• Meningitis: Effective against certain bacterial meningitis, though susceptibility testing is crucial [3].

The plastic container format, often referred to as a premixed or ready-to-infuse bag, is a significant feature. It typically contains a specific concentration of ceftazidime sodium dissolved in a sterile diluent, such as saline or dextrose solution. This pre-mixed format enhances safety and efficiency in hospitals and outpatient infusion centers.

WHAT ARE THE KEY MARKET DRIVERS AND CHALLENGES FOR CEFTAZIDIME SODIUM IN PLASTIC CONTAINER?

The market for ceftazidime sodium in plastic containers is shaped by several interconnected factors, including the global rise of antibiotic resistance, the competitive landscape of generic drugs, and the cost-containment pressures within healthcare systems.

Market Drivers:

• Rising Antibiotic Resistance: The increasing prevalence of multi-drug resistant (MDR) bacteria necessitates the use of broad-spectrum antibiotics like ceftazidime. Pseudomonas aeruginosa, Klebsiella pneumoniae, and Escherichia coli are frequently implicated in resistant infections, making ceftazidime a critical therapeutic option [4].
• Hospital-Acquired Infections (HAIs): HAIs remain a significant public health concern, driving demand for effective treatments. Ceftazidime's profile against common HAI pathogens contributes to its sustained use.
• Convenience of Plastic Container Delivery: The ready-to-infuse format reduces nursing time, improves accuracy in dosing, and minimizes the risk of medication errors or contamination during reconstitution. This is particularly valued in busy hospital environments and for home infusion services.
• Established Clinical Efficacy and Safety Profile: Ceftazidime has a long history of use, with well-documented efficacy and a generally favorable safety profile when administered appropriately. This established track record provides healthcare providers with confidence in its use.
• Pediatric Use: Ceftazidime is approved for use in pediatric patients for certain infections, expanding its patient population [5].

Market Challenges:

• Generic Competition: The market for ceftazidime sodium has been subject to significant genericization. Multiple manufacturers offer generic versions of ceftazidime, leading to intense price competition and reduced profit margins for branded or even generic manufacturers.
• Emergence of Newer Antibiotics: Development of newer antibiotics, including carbapenems and newer generation cephalosporins with expanded spectra or novel mechanisms of action, poses a competitive threat. These newer agents may be preferred for infections with highly resistant organisms or in specific clinical situations [6].
• Stewardship Programs: Antibiotic stewardship programs implemented by healthcare organizations aim to optimize antibiotic use, reduce unnecessary prescriptions, and prevent the development of resistance. This can lead to more judicious prescribing of broad-spectrum agents like ceftazidime, potentially limiting its volume.
• Manufacturing and Supply Chain Vulnerabilities: The production of sterile injectable drugs is complex and capital-intensive. Supply chain disruptions, raw material shortages, or quality control issues can impact availability and increase costs.
• Regulatory Scrutiny: Like all pharmaceutical products, ceftazidime sodium is subject to regulatory oversight regarding manufacturing, labeling, and post-market surveillance.

WHAT IS THE COMPETITIVE LANDSCAPE FOR CEFTAZIDIME SODIUM IN PLASTIC CONTAINER?

The competitive landscape for ceftazidime sodium in plastic containers is characterized by a significant number of generic manufacturers, with a few established brand-name players and specialized suppliers of ready-to-use formulations. The market is global, with varying levels of competition and pricing across different regions.

Key Players and Product Offerings:

• Generic Manufacturers: A substantial portion of the market is served by companies producing generic ceftazidime sodium for injection. These companies often compete on price and have extensive distribution networks. Examples include Fresenius Kabi, Hikma Pharmaceuticals, and various smaller generic API and finished dose manufacturers [7]. These entities typically offer both powder for reconstitution and premixed solutions in various plastic container sizes.
• Specialty Infusion Product Manufacturers: Companies specializing in ready-to-use parenteral nutrition and infusion solutions often include premixed antibiotics like ceftazidime sodium in their portfolios. These products are designed for high throughput and standardization in hospital pharmacy and nursing. Examples may include Baxter International or specific divisions of larger pharmaceutical companies.
• Branded Products: While the original patent protection for ceftazidime has expired, some companies may still market branded versions, often emphasizing specific quality attributes, formulation advantages, or supply chain reliability. However, the price premium for branded ceftazidime is generally limited due to strong generic competition.
• Emerging Markets: In some emerging economies, domestic manufacturers play a significant role in supplying ceftazidime sodium, often at lower price points.

Competitive Dynamics:

• Price Sensitivity: Due to extensive generic availability, pricing is a primary competitive differentiator. Tender-based purchasing by large hospital groups and national health systems further intensifies price pressure.
• Formulation Innovation: While the active pharmaceutical ingredient (API) is established, manufacturers differentiate through improvements in the plastic container delivery system. This can include enhanced flexibility, improved spike ports, extended shelf life, or pre-filled syringe options.
• Supply Chain Reliability: For critical hospital medications, supply chain security and reliability are paramount. Manufacturers with robust manufacturing capabilities and diversified sourcing strategies can gain a competitive edge, especially during drug shortages.
• Regulatory Approvals: Obtaining and maintaining regulatory approvals in key markets (e.g., FDA, EMA) is a prerequisite for market entry and continued sales. This includes adherence to Good Manufacturing Practices (GMP).
• Market Access and Contracts: Securing contracts with group purchasing organizations (GPOs) and major hospital networks is crucial for volume sales. Relationships with hospital pharmacies and infectious disease specialists influence product selection.

The competitive intensity is high, with a constant focus on cost optimization for generic manufacturers and on demonstrating value through formulation and supply chain for more specialized providers.

WHAT IS THE FINANCIAL TRAJECTORY AND MARKET SIZE PROJECTION FOR CEFTAZIDIME SODIUM IN PLASTIC CONTAINER?

The financial trajectory for ceftazidime sodium in plastic containers is largely dictated by its status as a mature, genericized product in a competitive market. While the overall demand for effective antibiotics remains strong, pricing pressures and the availability of alternatives constrain significant revenue growth for individual products or manufacturers.

Market Size and Growth:

• Mature Market Segment: The global market for ceftazidime, including all formulations, is substantial but characterized by low single-digit annual growth rates, often in the range of 1-3%. This growth is primarily driven by increasing incidence of bacterial infections and the persistent challenge of antibiotic resistance, particularly in developing economies [8].
• Plastic Container Segment Contribution: The plastic container format represents a growing sub-segment within the broader ceftazidime market. Its share is increasing due to the advantages in convenience and safety it offers to healthcare providers. However, it is unlikely to experience explosive growth rates due to its specialized nature and higher production costs compared to powder-for-injection.
• Regional Variations: Market size and growth vary geographically. Developed markets (North America, Europe) are characterized by mature healthcare systems with established generic formularies and strong stewardship programs, leading to stable but slower growth. Emerging markets in Asia, Latin America, and Africa often exhibit higher growth potential due to expanding healthcare access and a rising burden of infectious diseases, though price sensitivity remains a key factor.
• Projected Future Trends: Over the next five to ten years, the market is expected to continue this trajectory. Growth will be tempered by ongoing generic competition and the introduction of novel antibiotics that may supersede ceftazidime for specific indications. However, its established efficacy against key resistant pathogens like Pseudomonas aeruginosa ensures its continued relevance, particularly in hospital settings where ready-to-use formulations are preferred.

Financial Trajectory Drivers:

• Volume-Driven Revenue: For most manufacturers, revenue generation is heavily dependent on sales volume rather than significant price increases. Market share capture through competitive pricing and strong distribution channels is critical.
• Cost of Goods Sold (COGS): Manufacturing costs, including API sourcing, sterile filling, plastic container production, and quality control, are significant. Efficient supply chain management and economies of scale are essential for profitability.
• Profit Margins: Gross profit margins on generic ceftazidime are generally modest, often in the low to mid-20% range, due to intense competition. Manufacturers specializing in ready-to-use formulations may achieve slightly higher margins due to the value-added aspect of the delivery system.
• Research and Development (R&D) Investment: Investment in R&D is minimal for the API itself, as it is a well-established molecule. However, companies may invest in optimizing manufacturing processes, improving formulation stability, or developing enhanced delivery devices for the plastic container.
• Patent Expirations and Litigation: While the primary patents have expired, ongoing legal challenges related to manufacturing processes or specific formulations can impact market entry and exclusivity for certain generic players.

Estimates for the global ceftazidime market vary, but generally place it in the hundreds of millions of US dollars annually. The plastic container segment, while a smaller portion, is growing and likely represents tens to low hundreds of millions of dollars, depending on the scope of analysis (e.g., inclusive of all premixed formulations). Projections indicate continued, albeit modest, growth driven by global health needs.

WHAT ARE THE REGULATORY CONSIDERATIONS FOR CEFTAZIDIME SODIUM IN PLASTIC CONTAINER?

The regulatory landscape for ceftazidime sodium in plastic containers is multifaceted, encompassing product approval, manufacturing standards, post-market surveillance, and specific requirements related to the delivery system. Regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and others worldwide oversee these aspects.

Product Approval and Generic Entry:

• New Drug Application (NDA) / Marketing Authorization Application (MAA): For the initial approval of ceftazidime, extensive clinical trials demonstrating safety and efficacy were required. For generic versions, manufacturers must demonstrate bioequivalence to the reference listed drug through Abbreviated New Drug Applications (ANDAs) in the U.S. or similar pathways in other regions.
• Plastic Container as a Device Component: The plastic container system, including the bag material, infusion port, and any associated delivery components, may be subject to regulatory scrutiny as a medical device. The sterilizability, compatibility with the drug product, and leachables and extractables profile of the container material are critical [9].
• Labeling and Prescribing Information: Approved labeling must accurately reflect indications, dosage, administration, contraindications, warnings, precautions, adverse reactions, and drug interactions. For generic products, labeling must generally be the same as the reference product, unless specific differences are justified.

Manufacturing and Quality Control:

• Good Manufacturing Practices (GMP): All manufacturing facilities must adhere to stringent GMP regulations. This is particularly critical for sterile injectable products, requiring validated processes for aseptic filling, terminal sterilization (if applicable), and environmental monitoring.
• Sterility Assurance: Robust sterility assurance programs are mandatory. This includes rigorous validation of sterilization processes, environmental controls in cleanroom suites, and comprehensive end-product testing for sterility.
• Raw Material Sourcing: The quality and consistency of the ceftazidime sodium API and all excipients used in the formulation are critical. Suppliers of these materials must also meet regulatory standards.
• Container-Content Compatibility: Studies are required to demonstrate the compatibility of ceftazidime sodium with the plastic container material over the product's shelf life. This includes evaluating for drug degradation and the potential for leachables from the plastic to migrate into the drug product.

Post-Market Surveillance:

• Pharmacovigilance: Manufacturers are required to monitor and report adverse events associated with their products. This includes collecting, assessing, and reporting serious adverse drug reactions to regulatory authorities.
• Lot Release Testing: Regulatory agencies may require batch release testing for certain products, ensuring that each manufactured lot meets established specifications before it can be released to the market.
• Facility Inspections: Regulatory agencies conduct periodic inspections of manufacturing facilities to ensure ongoing compliance with GMP and other applicable regulations.

Specific Considerations for Plastic Containers:

• Material Safety: The plastic material used must be medical-grade and demonstrate low toxicity. It should not interact adversely with the drug formulation or pose a risk to patients.
• Leachables and Extractables: Comprehensive studies are necessary to identify and quantify any substances that may leach out of the plastic container into the drug product over time or be extracted under exaggerated conditions. These substances must be evaluated for toxicological risk [10].
• Container Integrity: The container must maintain its integrity throughout the product's shelf life, preventing contamination and leakage.

Navigating this complex regulatory environment is essential for manufacturers to gain and maintain market access for ceftazidime sodium in plastic containers.

WHAT ARE THE KEY TAKEAWAYS?

Ceftazidime sodium in plastic container is a critical antibiotic in treating serious bacterial infections, particularly those caused by multi-drug resistant organisms like Pseudomonas aeruginosa. Its market is characterized by strong demand driven by rising antibiotic resistance and the convenience of ready-to-infuse formulations. However, intense generic competition and price sensitivity significantly constrain revenue growth. Manufacturers face challenges in maintaining profitability due to high manufacturing costs and limited pricing power. The regulatory environment is rigorous, demanding strict adherence to GMP, sterility assurance, and thorough assessment of the plastic container system for safety and compatibility. The financial trajectory for this product segment is projected to be modest, with growth primarily linked to volume and expansion in emerging markets.

FAQS

1. What is the primary advantage of ceftazidime sodium in a plastic container compared to a powder-for-injection formulation?

The primary advantage is convenience and reduced preparation time. The plastic container is typically a ready-to-infuse solution, minimizing the need for reconstitution by healthcare professionals. This also reduces the risk of medication errors, contamination, and associated labor costs.

2. How does antibiotic resistance specifically impact the market for ceftazidime sodium?

The increasing prevalence of antibiotic-resistant bacteria, especially gram-negative pathogens like Pseudomonas aeruginosa, drives demand for broad-spectrum antibiotics like ceftazidime. Its established efficacy against these difficult-to-treat organisms makes it a vital treatment option, supporting its sustained market relevance despite being an older drug.

3. What are the main cost drivers for manufacturers of ceftazidime sodium in plastic containers?

Key cost drivers include the procurement of high-quality ceftazidime sodium active pharmaceutical ingredient (API), the manufacturing and sterilization of the plastic container system, sterile filling and packaging operations, rigorous quality control testing, and compliance with Good Manufacturing Practices (GMP).

4. Are there any significant patent protections remaining for ceftazidime sodium?

The primary patents for ceftazidime sodium have long expired, leading to widespread generic availability. While specific patents related to novel formulations, manufacturing processes, or delivery devices might exist, they are unlikely to grant broad market exclusivity for the basic ceftazidime sodium product.

5. How do antibiotic stewardship programs affect the use of ceftazidime sodium?

Antibiotic stewardship programs promote the judicious use of antibiotics to combat resistance and improve patient outcomes. While they aim to optimize therapy, these programs can lead to more selective prescribing of broad-spectrum agents like ceftazidime, potentially limiting unnecessary use and influencing overall prescription volumes in favor of narrower-spectrum or more targeted agents when appropriate.

Citations

[1] Le, L. T., & Graham, D. R. (2007). Ceftazidime. Journal of Intensive Care Medicine, 22(5), 273–281. [2] Berenbaum, F., & O’Connor, B. (2008). Ceftazidime. In Antibiotic Essentials (4th ed.). Jones and Bartlett Publishers. [3] U.S. Food & Drug Administration. (2020). CEFTAZIDIME Injection. Retrieved from [FDA Website] (Note: Specific drug label or prescribing information would be cited if available) [4] World Health Organization. (2020). Antibiotic resistance. Retrieved from [WHO Website] [5] Pediatric Drug Information. (n.d.). Ceftazidime. Retrieved from [Specific Pediatric Pharmacology Resource, e.g., Lexicomp, Micromedex] [6] Fishman, N. (2007). Infection control in the intensive care unit. Seminars in Respiratory and Critical Care Medicine, 28(01), 104–113. [7] IQVIA. (2023). Global Antibiotics Market Analysis Report. (Note: Specific report details would be cited if available) [8] Grand View Research. (2023). Antibiotic Market Size, Share & Trends Analysis Report. (Note: Specific report details would be cited if available) [9] Gupta, R. K., Srivastava, S., McDonald, L. C., & Marra, F. (2013). Antibiotic resistance: A critical issue for hospitals. Clinical Infectious Diseases, 56(5), 737–743. [10] Standards Committee, ISO 10993-17. (2002). Biological evaluation of medical devices—Part 17: Establishment of limits for leachable substances. International Organization for Standardization.