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Last Updated: December 22, 2024

CIPROFLOXACIN EXTENDED RELEASE Drug Patent Profile


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When do Ciprofloxacin Extended Release patents expire, and what generic alternatives are available?

Ciprofloxacin Extended Release is a drug marketed by Ani Pharms, Dr Reddys Labs Ltd, Endo Operations, Fosun Pharma, and Rising. and is included in five NDAs.

The generic ingredient in CIPROFLOXACIN EXTENDED RELEASE is ciprofloxacin; ciprofloxacin hydrochloride. There are thirty-four drug master file entries for this compound. Additional details are available on the ciprofloxacin; ciprofloxacin hydrochloride profile page.

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Summary for CIPROFLOXACIN EXTENDED RELEASE
Drug patent expirations by year for CIPROFLOXACIN EXTENDED RELEASE
Recent Clinical Trials for CIPROFLOXACIN EXTENDED RELEASE

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

SponsorPhase
British University In EgyptEarly Phase 1
Future University in EgyptPhase 1
Cairo UniversityN/A

See all CIPROFLOXACIN EXTENDED RELEASE clinical trials

US Patents and Regulatory Information for CIPROFLOXACIN EXTENDED RELEASE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077809-002 Nov 30, 2010 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fosun Pharma CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 078712-001 Dec 11, 2007 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd CIPROFLOXACIN EXTENDED RELEASE ciprofloxacin; ciprofloxacin hydrochloride TABLET, EXTENDED RELEASE;ORAL 077701-001 Mar 26, 2007 RX No 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

CIPROFLOXACIN EXTENDED RELEASE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ciprofloxacin Extended Release

Introduction

Ciprofloxacin Extended Release (XR) is a formulation of the fluoroquinolone antibiotic ciprofloxacin, designed for once-daily administration. This article delves into the market dynamics and financial trajectory of Ciprofloxacin XR, highlighting its pharmacokinetics, market performance, and future outlook.

Pharmacokinetics of Ciprofloxacin XR

Ciprofloxacin XR is formulated as a bilayer tablet, consisting of an immediate-release layer and a controlled-release layer. This design allows for higher maximum plasma concentrations (Cmax) compared to the immediate-release formulation, while maintaining equivalent area under the curve (AUC) values over 24 hours[4][5].

Clinical Efficacy

Ciprofloxacin XR has demonstrated efficacy in treating uncomplicated and complicated urinary tract infections (UTIs), as well as acute uncomplicated pyelonephritis. The bacteriological eradication rates and clinical cure rates for Ciprofloxacin XR are similar to those of the immediate-release formulation[1][4].

Market Size and Growth

The extended-release drugs market, which includes Ciprofloxacin XR, has been growing rapidly. In 2023, the global extended-release drugs market was valued at $57.11 billion and is expected to grow to $63.82 billion in 2024, with a compound annual growth rate (CAGR) of 11.7%. By 2028, the market is projected to reach $99.77 billion, driven by factors such as improved patient compliance, the prevalence of chronic diseases, and advancements in drug delivery systems[3].

Market Drivers

Several factors are driving the growth of the extended-release drugs market, including:

Patient Compliance

Extended-release formulations like Ciprofloxacin XR improve patient compliance by reducing the frequency of administration, which is particularly beneficial for chronic conditions[3].

Chronic Disease Prevalence

The increasing incidence of chronic diseases such as heart disease, cancer, obesity, and diabetes is driving the demand for extended-release medications. By 2050, the number of individuals aged 50 and older with at least one chronic illness is expected to surge by 99.5%[3].

Pharmaceutical Industry Demand

The pharmaceutical industry's focus on discovery, development, and marketing of drugs contributes significantly to the growth of the extended-release market. Extended-release drugs enhance therapeutic outcomes, reduce side effects, and provide a better overall pharmaceutical experience[3].

Market Segmentation

The extended-release drugs market is segmented by type (sustained release and controlled release), mode (over-the-counter and prescription), and distribution channel (hospital pharmacies, retail pharmacies, mail order pharmacies, and drug stores). Ciprofloxacin XR falls under the prescription and controlled release categories[3].

Financial Trajectory

The financial performance of companies involved in the development and marketing of extended-release drugs, including Ciprofloxacin XR, is influenced by several factors:

Research and Development Expenses

Companies like NeuroSense, although not directly involved in Ciprofloxacin XR, illustrate the trend in research and development expenses. These expenses can fluctuate based on the phase of clinical trials and the complexity of drug development. For instance, NeuroSense saw a decrease in research and development expenses by 14% in the nine months ended September 30, 2024, due to reduced subcontractor and consultant expenses[2].

Market Competition

The extended-release market is competitive, with multiple players offering various formulations. The success of Ciprofloxacin XR is partly due to its efficacy and the convenience of once-daily dosing, which differentiates it from immediate-release formulations.

Regulatory Compliance

Regulatory approvals and compliance are crucial for the financial trajectory of any drug. Ciprofloxacin XR has received necessary approvals and is subject to postmarketing study commitments to ensure ongoing efficacy and safety[4].

Future Outlook

The future outlook for Ciprofloxacin XR is positive, driven by the growing demand for extended-release medications. Here are some key points:

Advancements in Drug Delivery Systems

Advancements in drug delivery systems, including nanotechnology and 3D printing, are expected to further enhance the efficacy and patient compliance of extended-release drugs like Ciprofloxacin XR[3].

Personalized Medicine

The trend towards personalized medicine is likely to increase the demand for tailored extended-release formulations, potentially benefiting Ciprofloxacin XR[3].

Global Access

The increasing global access to extended-release therapies will expand the market reach of Ciprofloxacin XR, particularly in regions with high prevalence of chronic diseases[3].

Key Takeaways

  • Pharmacokinetics: Ciprofloxacin XR offers higher Cmax and equivalent AUC compared to immediate-release formulations.
  • Clinical Efficacy: Similar bacteriological eradication and clinical cure rates to immediate-release ciprofloxacin.
  • Market Growth: Part of a rapidly growing extended-release drugs market, driven by patient compliance and chronic disease prevalence.
  • Financial Trajectory: Influenced by research and development expenses, market competition, and regulatory compliance.
  • Future Outlook: Positive, driven by advancements in drug delivery systems, personalized medicine, and global access.

FAQs

What is the primary advantage of Ciprofloxacin XR over immediate-release ciprofloxacin?

The primary advantage is the convenience of once-daily administration, which improves patient compliance.

How does Ciprofloxacin XR compare in terms of efficacy to immediate-release ciprofloxacin?

Ciprofloxacin XR has similar bacteriological eradication and clinical cure rates to immediate-release ciprofloxacin[1].

What are the key drivers of the extended-release drugs market?

Key drivers include improved patient compliance, the prevalence of chronic diseases, and advancements in drug delivery systems[3].

How is the financial performance of companies involved in extended-release drugs affected?

Financial performance is influenced by research and development expenses, market competition, and regulatory compliance[2].

What are the future trends expected to impact Ciprofloxacin XR?

Future trends include advancements in drug delivery systems, personalized medicine, and increased global access to extended-release therapies[3].

Sources

  1. Ciprofloxacin extended release: in the treatment of urinary ... - PubMed
  2. NeuroSense Provides Business Update and Third Quarter 2024 ... - PR Newswire
  3. Global Extended Release Drugs Market Report 2024 - The Business Research Company
  4. CIPRO XR (ciprofloxacin extended-release) Tablets (1 gram) - FDA
  5. CIPRO XR - accessdata.fda.gov

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