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Last Updated: December 22, 2024

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Ancef In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Ancef In Dextrose 5% In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER is cefazolin sodium. There are twenty-seven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the cefazolin sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ancef In Dextrose 5% In Plastic Container

A generic version of ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER was approved as cefazolin sodium by SANDOZ on December 9th, 1988.

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Summary for ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for ANCEF IN DEXTROSE 5% 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 ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-003 Jun 8, 1983 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER cefazolin sodium INJECTABLE;INJECTION 050566-004 Jun 8, 1983 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ANCEF in Dextrose 5% in Plastic Container

Introduction to ANCEF

ANCEF, also known as cefazolin, is a first-generation cephalosporin antibiotic used to treat various bacterial infections. It is often administered in a solution with dextrose, particularly in a plastic container known as the DUPLEX® Container.

Market Overview

The antibiotic market, particularly for cephalosporins like ANCEF, is driven by several key factors:

Increasing Demand for Antibiotics

The global demand for antibiotics is rising due to the increasing incidence of bacterial infections and the growing need for effective treatments. ANCEF, being a widely used antibiotic, benefits from this trend[4].

Hospital and Surgical Settings

ANCEF is frequently used in hospital and surgical settings for perioperative prophylaxis, especially in procedures where infection risk is high, such as open-heart surgery and prosthetic arthroplasty. This consistent demand from healthcare institutions contributes to its market stability[2].

Regulatory Environment

Regulatory bodies like the FDA play a crucial role in ensuring the safety and efficacy of antibiotics. Compliance with FDA guidelines and maintaining good manufacturing practices are essential for the continued market presence of ANCEF[4].

Financial Trajectory

Revenue Growth

The revenue generated by ANCEF is influenced by its widespread use in clinical settings. The drug's effectiveness and the necessity of antibiotic prophylaxis in surgeries contribute to steady sales. For instance, the use of ANCEF in lengthy operative procedures and the need for additional doses during and post-surgery ensure a consistent revenue stream[2].

Pricing and Competition

The pricing of ANCEF is competitive within the antibiotic market. Generic versions of cefazolin are available, which can impact the pricing strategy of branded products like ANCEF. However, the convenience and reliability of the DUPLEX® Container system can justify premium pricing in some markets[4].

Cost of Production

The cost of producing ANCEF includes the expenses associated with the lyophilized form of cefazolin, the sterile iso-osmotic diluent, and the specialized DUPLEX® Container. These costs are balanced against the revenue generated to ensure profitability[4].

Market Segmentation

Hospital and Clinical Use

ANCEF is primarily used in hospital settings for treating and preventing infections. This segment is a significant contributor to its market share due to the high volume of surgical procedures requiring antibiotic prophylaxis[2].

Pediatric and Adult Patients

The drug is used in both pediatric and adult patients, with specific dosing recommendations for each group. For pediatric patients, the dosing is adjusted based on weight and renal function, ensuring a broad market reach[1].

Competitive Landscape

Generic Competition

The availability of generic cefazolin can pose a challenge to the market share of branded ANCEF. However, the unique packaging and delivery system of ANCEF can differentiate it from generic alternatives[4].

Other Cephalosporins

Other cephalosporins, such as ceftriaxone and cefotaxime, compete with ANCEF in the antibiotic market. Each has its own indications and advantages, but ANCEF's specific use in surgical prophylaxis maintains its market position[2].

Regulatory and Safety Considerations

FDA Guidelines

ANCEF must comply with FDA guidelines to ensure its continued approval and market presence. This includes adhering to dosage recommendations, monitoring for adverse effects, and maintaining quality control in manufacturing[4].

Adverse Effects and Safety

The drug is associated with potential adverse effects such as pseudomembranous colitis, toxic nephropathy, and hypersensitivity reactions. Monitoring and managing these risks are crucial for maintaining patient safety and market trust[2].

Market Trends and Future Outlook

Increasing Resistance to Antibiotics

The growing concern of antibiotic resistance impacts the long-term market dynamics of ANCEF. Efforts to use antibiotics judiciously and only when necessary are critical to maintaining their effectiveness[2].

Technological Advancements

Advancements in packaging and delivery systems, such as the DUPLEX® Container, can enhance the convenience and safety of ANCEF administration, potentially increasing its market appeal[4].

Global Health Initiatives

Global health initiatives aimed at reducing infections and improving surgical outcomes can increase the demand for antibiotics like ANCEF, particularly in regions with high infection rates[2].

Key Takeaways

  • Market Demand: Driven by the need for effective antibiotic treatments in hospital and surgical settings.
  • Financial Stability: Supported by consistent demand and the necessity of antibiotic prophylaxis in surgeries.
  • Competitive Edge: Differentiated by the unique DUPLEX® Container system and specific indications.
  • Regulatory Compliance: Critical for maintaining market presence and ensuring patient safety.
  • Future Outlook: Influenced by the need to address antibiotic resistance and technological advancements.

FAQs

Q: What is ANCEF used for?

A: ANCEF (cefazolin) is used to treat various bacterial infections, particularly in hospital and surgical settings for perioperative prophylaxis.

Q: How is ANCEF administered?

A: ANCEF is administered intravenously or intramuscularly, often in a solution with dextrose, using the DUPLEX® Container system.

Q: What are the potential side effects of ANCEF?

A: Potential side effects include pseudomembranous colitis, toxic nephropathy, and hypersensitivity reactions.

Q: How does the DUPLEX® Container system benefit ANCEF administration?

A: The DUPLEX® Container system provides a convenient and safe method for administering ANCEF, reducing the risk of air embolism and ensuring the solution is clear and free from particulate matter.

Q: What are the dosing recommendations for pediatric patients?

A: For pediatric patients, the dosing of ANCEF is adjusted based on weight and renal function, typically ranging from 25 to 100 mg/kg divided into 3 or 4 equal doses[1].

Sources

  1. Drugs.com: Cefazolin and Dextrose: Package Insert / Prescribing Info.
  2. GlobalRPH: Dilution Ancef® - cefazolin.
  3. FDA: ANCEF Label.
  4. FDA.report: Cefazolin Sodium Injection, Solution.
  5. DailyMed: Cefazolin Sodium Injection, Solution.

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