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Last Updated: December 22, 2024

CEFAZOLIN IN DEXTROSE Drug Patent Profile


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Which patents cover Cefazolin In Dextrose, and what generic alternatives are available?

Cefazolin In Dextrose is a drug marketed by Baxter Hlthcare Corp and is included in one NDA.

The generic ingredient in CEFAZOLIN IN DEXTROSE 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 Cefazolin In Dextrose

A generic version of CEFAZOLIN IN DEXTROSE was approved as cefazolin sodium by SANDOZ on December 9th, 1988.

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Recent Clinical Trials for CEFAZOLIN IN DEXTROSE

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SponsorPhase
St. Louis UniversityPhase 4
Federico II UniversityN/A
Abdul El-RabbanyPhase 4

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Pharmacology for CEFAZOLIN IN DEXTROSE

US Patents and Regulatory Information for CEFAZOLIN IN DEXTROSE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare Corp CEFAZOLIN IN DEXTROSE cefazolin sodium SOLUTION;INTRAVENOUS 207131-002 Feb 1, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare Corp CEFAZOLIN IN DEXTROSE cefazolin sodium SOLUTION;INTRAVENOUS 207131-001 Aug 7, 2015 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare Corp CEFAZOLIN IN DEXTROSE cefazolin sodium SOLUTION;INTRAVENOUS 207131-003 May 31, 2024 RX Yes Yes ⤷  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

CEFAZOLIN IN DEXTROSE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Cefazolin in Dextrose

Introduction to Cefazolin in Dextrose

Cefazolin in Dextrose is a cephalosporin antibacterial drug used to treat a variety of bacterial infections and for preoperative prophylaxis. It is administered intravenously and is effective against a range of microorganisms, including Streptococcus pneumoniae, Staphylococcus aureus, and Escherichia coli[2][4][5].

Indications and Usage

Cefazolin in Dextrose is indicated for the treatment of several types of infections, including respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, and septicemia. It is also used for perioperative prophylaxis to reduce the incidence of postoperative infections in high-risk surgical patients[2][4][5].

Market Demand and Supply

The demand for Cefazolin in Dextrose is driven by its efficacy in treating serious bacterial infections and its role in surgical prophylaxis. However, the market has faced challenges due to drug shortages. For instance, Cefazolin injection was on the FDA’s drug shortage list for over a year due to high demand, highlighting the need for reliable supply chains[1].

Manufacturing and Distribution

Baxter, a leading healthcare company, has been instrumental in addressing the supply issues through innovative manufacturing and distribution strategies. The introduction of Cefazolin 2 gram frozen premix in the GALAXY container has improved pharmacy efficiency and provided additional supply options. This development is part of Baxter’s partnership with Celerity Pharmaceuticals, LLC, aimed at accelerating the development of critical care medications[1].

Financial Trajectory

Development Costs

The development of pharmaceuticals like Cefazolin in Dextrose involves significant costs. The estimated cost for developing a new chemical entity (NCE) can be as high as $1.2 billion, with a substantial portion attributed to the costs of failures and the elimination of unsuccessful compounds. The pivotal phase III clinical trials, which involve thousands of patients, are particularly expensive[3].

Revenue Potential

Despite the high development costs, successful pharmaceutical products can generate substantial revenue. "Blockbuster" drugs, which achieve sales of over $1 billion per year, can provide significant profits that help pharmaceutical companies reinvest in research and fund their product development pipelines[3].

Market Competition and Timing

The financial success of a drug like Cefazolin in Dextrose is also influenced by market competition and the timing of its launch. A delay in market entry can result in a loss of potential profit, as competitor products may capture market share and dictate market prices. For example, a product that is six months late to market can miss out on one-third of its potential profit over its lifetime[3].

Pricing and Reimbursement

The pricing of Cefazolin in Dextrose is influenced by various factors, including production costs, market demand, and reimbursement policies. Pharmaceutical companies must balance the need to recoup development costs with the need to maintain competitive pricing. Reimbursement policies by healthcare providers and insurance companies also play a crucial role in determining the financial viability of the drug[3].

Regulatory Environment

The regulatory environment is another critical factor in the financial trajectory of Cefazolin in Dextrose. Compliance with FDA regulations and guidelines is essential for maintaining market approval and avoiding costly recalls or legal issues. The drug's inclusion on the FDA’s drug shortage list highlights the importance of regulatory oversight in ensuring consistent supply and quality[1][2].

Usage in Clinical Settings

Cefazolin in Dextrose is widely used in clinical settings due to its broad spectrum of activity and its suitability for various patient populations, including adults and pediatric patients. Its use in perioperative prophylaxis is particularly significant, as it helps reduce the incidence of postoperative infections, which can have substantial economic and health implications[2][4][5].

Dosage and Administration

The drug's dosage and administration guidelines are critical for its effective use. Cefazolin in Dextrose is administered intravenously, and the recommended dosages vary based on the type and severity of the infection, as well as the patient's renal function. Adherence to these guidelines is essential for optimizing therapeutic outcomes and minimizing the risk of adverse effects[2][4].

Limitations and Alternatives

While Cefazolin in Dextrose is effective for many infections, there are limitations to its use. For example, it is not recommended for patients with a history of allergic reactions to cephalosporins. Additionally, alternative formulations may be necessary for doses that do not equal 1 gram, 2 grams, or 3 grams[2][4].

Future Outlook

The future outlook for Cefazolin in Dextrose is promising, given its established efficacy and the ongoing efforts to improve supply chain reliability. As healthcare needs continue to evolve, the demand for effective antibacterial agents like Cefazolin in Dextrose is likely to remain strong. Innovations in manufacturing and distribution, along with strategic partnerships, will be key to maintaining market competitiveness and ensuring consistent availability of this critical medication.

Key Takeaways

  • Broad Spectrum of Activity: Cefazolin in Dextrose is effective against a wide range of bacterial infections.
  • Preoperative Prophylaxis: It is used to reduce postoperative infections in high-risk surgical patients.
  • Supply Chain Challenges: The drug has faced shortages, but innovative manufacturing solutions are addressing these issues.
  • High Development Costs: The development of pharmaceuticals like Cefazolin in Dextrose involves significant costs.
  • Revenue Potential: Successful drugs can generate substantial revenue to reinvest in research and development.
  • Regulatory Compliance: Adherence to FDA regulations is crucial for maintaining market approval.

FAQs

What is Cefazolin in Dextrose used for?

Cefazolin in Dextrose is used to treat various bacterial infections, including respiratory tract infections, urinary tract infections, and skin and skin structure infections. It is also used for preoperative prophylaxis to prevent postoperative infections[2][4][5].

Why has Cefazolin injection been on the FDA’s drug shortage list?

Cefazolin injection has been on the FDA’s drug shortage list due to high demand and supply chain issues, but companies like Baxter are working to address these shortages through innovative manufacturing and distribution strategies[1].

How is Cefazolin in Dextrose administered?

Cefazolin in Dextrose is administered intravenously, with dosages varying based on the type and severity of the infection, as well as the patient's renal function[2][4].

What are the potential side effects of Cefazolin in Dextrose?

While Cefazolin in Dextrose is generally well-tolerated, potential side effects include allergic reactions, particularly in patients with a history of cephalosporin allergy. Other side effects may include gastrointestinal disturbances and local reactions at the injection site[2][4].

Can Cefazolin in Dextrose be used in pediatric patients?

Yes, Cefazolin in Dextrose can be used in pediatric patients aged 10 to 17 years for perioperative prophylaxis and for treating various infections, with dosages adjusted according to the patient's weight and renal function[2][4].

Cited Sources

  1. Baxter. "FOR IMMEDIATE RELEASE - Baxter."
  2. DailyMed. "CEFAZOLIN- cefazolin sodium injection, solution - DailyMed."
  3. Informa Healthcare. "SECOND EDITION - Pharmaceutical Preformulation and Formulation."
  4. Drugs.com. "Cefazolin and Dextrose: Package Insert / Prescribing Info - Drugs.com."
  5. St. Luke's Health. "Cefazolin/dextrose premix (By injection) | Drug Notes."

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