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Last Updated: December 22, 2024

CIPROFLOXACIN IN DEXTROSE 5% Drug Patent Profile


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Which patents cover Ciprofloxacin In Dextrose 5%, and what generic alternatives are available?

Ciprofloxacin In Dextrose 5% is a drug marketed by Hikma Farmaceutica, Baxter Hlthcare, Baxter Hlthcare Corp, Bedford, Hospira, Inforlife, and Teva Pharms. and is included in eight NDAs.

The generic ingredient in CIPROFLOXACIN IN DEXTROSE 5% is ciprofloxacin. There are thirty-four drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ciprofloxacin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ciprofloxacin In Dextrose 5%

A generic version of CIPROFLOXACIN IN DEXTROSE 5% was approved as ciprofloxacin by BAXTER HLTHCARE CORP on April 29th, 2008.

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Summary for CIPROFLOXACIN IN DEXTROSE 5%
Drug patent expirations by year for CIPROFLOXACIN IN DEXTROSE 5%
Recent Clinical Trials for CIPROFLOXACIN IN DEXTROSE 5%

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SponsorPhase
Institute of Cancer Research, United KingdomPhase 1/Phase 2
Prostate Cancer FoundationPhase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, ChinaPhase 4

See all CIPROFLOXACIN IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for CIPROFLOXACIN IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Farmaceutica CIPROFLOXACIN IN DEXTROSE 5% ciprofloxacin INJECTABLE;INJECTION 076757-001 Apr 21, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bedford CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078114-002 Mar 18, 2008 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare Corp CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078024-001 Mar 18, 2008 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Inforlife CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER ciprofloxacin INJECTABLE;INJECTION 078252-002 Mar 18, 2008 AP RX No 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

CIPROFLOXACIN IN DEXTROSE 5% Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciprofloxacin in 5% Dextrose

Introduction to Ciprofloxacin

Ciprofloxacin, a fluoroquinolone antibacterial, has been a significant player in the pharmaceutical market since its initial U.S. approval in 1990. It is widely used for treating various infections, including skin and skin structure infections, bone and joint infections, and other serious bacterial infections[4].

Market Demand and Usage

Clinical Indications

Ciprofloxacin in 5% Dextrose is indicated for adults and, in some cases, pediatric patients with specific infections caused by susceptible bacteria. The drug's broad-spectrum efficacy against a range of pathogens, including Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa, contributes to its high demand in clinical settings[4].

Patient Population

The drug is particularly valuable in treating patients with severe infections who require intravenous therapy. This includes patients with skin and skin structure infections, bone and joint infections, and those who cannot be treated with oral antibiotics due to the severity of their condition or other health complications[4].

Economic Impact

Cost Reduction

The use of ciprofloxacin, especially in its oral form, has significant economic benefits. It reduces the costs associated with parenteral therapy, such as labor, supplies, and equipment. Additionally, oral administration can lead to shorter hospital stays and reduced need for expensive parenteral drugs, thereby lowering overall healthcare costs[3].

Hospital Budgets

For hospitals, the fiscal impact of using ciprofloxacin can be substantial. By reducing the need for prolonged intravenous therapy and associated costs, hospitals can allocate resources more efficiently. This is particularly important under diagnostic-related group (DRG) or prospective payment systems, where there is pressure to control costs while maintaining care quality[3].

Stability and Compatibility

Storage and Administration

Ciprofloxacin solutions in 5% dextrose and normal saline are stable for at least 3 months when stored at room or refrigerator temperatures. This stability ensures that the drug can be safely stored and administered without significant degradation, which is crucial for both inpatient and outpatient therapy[1][2].

Compatibility Issues

While ciprofloxacin is compatible with 0.9% Sodium Chloride (NS) and Dextrose 5% in Water (D5W), it is incompatible with many other drugs. This requires careful management and monitoring by healthcare professionals to avoid adverse interactions[2].

Adverse Reactions and Safety Considerations

Serious Adverse Reactions

Ciprofloxacin is associated with several serious adverse reactions, including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis. These risks necessitate careful patient selection and monitoring, which can impact its market dynamics by limiting its use to patients with no alternative treatment options[4].

Monitoring and Management

Healthcare providers must closely monitor patients for signs of adverse reactions, such as phlebitis, central nervous system stimulation, psychiatric effects, and liver dysfunction. This intensive monitoring can influence the drug's usage patterns and overall market acceptance[2][4].

Market Competition

Generic and Branded Versions

The availability of both generic and branded versions of ciprofloxacin affects market dynamics. Generic versions can reduce costs for patients and healthcare systems, potentially increasing the drug's market share. However, branded versions may retain market presence due to brand loyalty and perceived quality differences[4].

Alternative Antibiotics

The market for ciprofloxacin is also influenced by the availability of other antibiotics. The rise of antibiotic resistance and the development of new antimicrobial agents can shift market preferences and impact the demand for ciprofloxacin[4].

Regulatory Environment

FDA Guidelines and Warnings

The FDA has issued warnings and guidelines for the use of ciprofloxacin, highlighting its potential for serious adverse reactions. These regulatory actions can affect prescribing practices and patient safety, thereby influencing the drug's market trajectory[4].

Financial Trajectory

Revenue Trends

The revenue generated by ciprofloxacin is influenced by its widespread use in clinical settings, the availability of generic versions, and the overall demand for effective antibacterial treatments. Despite the presence of generic versions, the branded market for ciprofloxacin remains significant due to its established reputation and clinical efficacy[4].

Cost-Benefit Analysis

The financial trajectory of ciprofloxacin is also shaped by its cost-benefit profile. While the drug offers significant clinical benefits, its use must be balanced against the potential for adverse reactions and the costs associated with monitoring and managing these risks. This balance is crucial for healthcare providers and payers when making treatment decisions[3][4].

Future Outlook

Antibiotic Resistance

The future market for ciprofloxacin will be influenced by the ongoing challenge of antibiotic resistance. As bacteria develop resistance to fluoroquinolones, the effectiveness and demand for ciprofloxacin may decline, prompting the development and use of new antimicrobial agents[4].

Innovations in Delivery

Advancements in drug delivery systems and the development of new formulations could enhance the stability, compatibility, and safety profile of ciprofloxacin, potentially boosting its market position. However, these innovations must be balanced against the economic and regulatory factors that influence drug development and approval[1][2].

Key Takeaways

  • Clinical Efficacy: Ciprofloxacin in 5% Dextrose is a highly effective treatment for various bacterial infections.
  • Economic Benefits: The drug offers significant cost reductions by minimizing the need for prolonged intravenous therapy and associated costs.
  • Stability and Compatibility: The solution is stable for at least 3 months under appropriate storage conditions but has compatibility issues with many other drugs.
  • Adverse Reactions: The drug is associated with serious adverse reactions, necessitating careful patient selection and monitoring.
  • Market Competition: The market is influenced by the availability of generic and branded versions, as well as alternative antibiotics.
  • Regulatory Environment: FDA guidelines and warnings impact prescribing practices and patient safety.

FAQs

  1. What are the common indications for ciprofloxacin in 5% Dextrose?

    • Ciprofloxacin in 5% Dextrose is indicated for skin and skin structure infections, bone and joint infections, and other serious bacterial infections caused by susceptible bacteria[4].
  2. How stable is ciprofloxacin in 5% Dextrose?

    • Ciprofloxacin solutions in 5% Dextrose are stable for at least 3 months when stored at room or refrigerator temperatures[1].
  3. What are the potential serious adverse reactions associated with ciprofloxacin?

    • Serious adverse reactions include tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and exacerbation of myasthenia gravis[4].
  4. How does ciprofloxacin impact hospital budgets?

    • Ciprofloxacin can reduce hospital costs by minimizing the need for prolonged intravenous therapy, associated labor, supplies, and equipment[3].
  5. What are the compatibility issues with ciprofloxacin in 5% Dextrose?

    • Ciprofloxacin is incompatible with many drugs and requires careful management to avoid adverse interactions[2].

Sources

  1. Stability of ciprofloxacin in 5% dextrose and normal saline injections - PubMed[1]
  2. Ciprofloxacin - ISMP Canada - ISMP Canada[2]
  3. Economic impact of oral ciprofloxacin. A pharmacist's perspective - PubMed[3]
  4. Ciprofloxacin in 5% Dextrose: Package Insert / Prescribing Info - Drugs.com[4]
  5. Ciprofloxacin Monograph - Paediatric - Perth Children's Hospital[5]

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