FLOXIN IN DEXTROSE 5% Drug Patent Profile

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

Floxin In Dextrose 5% is a drug marketed by Ortho Mcneil Pharm and is included in one NDA.

The generic ingredient in FLOXIN IN DEXTROSE 5% is ofloxacin. There are seventy-eight drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ofloxacin profile page.

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

A generic version of FLOXIN IN DEXTROSE 5% was approved as ofloxacin by CHARTWELL RX on September 2^nd, 2003.

Summary for FLOXIN IN DEXTROSE 5%

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	8
DailyMed Link:	FLOXIN IN DEXTROSE 5% at DailyMed

Recent Clinical Trials for FLOXIN IN DEXTROSE 5%

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

Sponsor	Phase
Montefiore Medical Center	Phase 3
University of California, San Francisco	Phase 4
Winston Chamberlain, MD, PhD	Phase 4

See all FLOXIN IN DEXTROSE 5% clinical trials

US Patents and Regulatory Information for FLOXIN 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
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992		DISCN	No	No

Expired US Patents for FLOXIN IN DEXTROSE 5%

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992

International Patents for FLOXIN IN DEXTROSE 5%

See the table below for patents covering FLOXIN IN DEXTROSE 5% around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	8105604
Philippines	18276	BENZOXAZINE DERIVATIVES AND PROCESS OF PREPARATION
Norway	812956

Supplementary Protection Certificates for FLOXIN IN DEXTROSE 5%

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	SPC/GB12/058	United Kingdom		PRODUCT NAME: A COMBINATION OF CIPROFLOXACIN AND DEXAMETHASONE, PREFERABLY CIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONE; REGISTERED: DK DE/11/3337/001/DC 20120808; UK PL000649/0381-0001 20121003
1429780	122012000070	Germany		PRODUCT NAME: KOMBINATION AUS CIPROFLOXACIN UND DEXAMETHASON, INSBESONDERE CIPROFLOXACINHYDROCHLORID UND DEXAMETHASON; NAT. REGISTRATION NO/DATE: 85150.00. 00 20120830; FIRST REGISTRATION: DAENEMARK 48976 20120808
1429780	13C0012	France		PRODUCT NAME: COMBINAISON DE CIPROFLOXACINE ET DE DEXAMETHASONE, EN PARTICULIER DE CHLORHYDRATE DE CIPROFLOXACINE ET DE DEXAMETHASONE; NAT. REGISTRATION NO/DATE: NL 41308 20121214; FIRST REGISTRATION: 48976 20120808

Market Dynamics and Financial Trajectory for FLOXIN IN DEXTROSE 5%

Last updated: July 30, 2025

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Introduction

FLOXIN IN DEXTROSE 5%, a generic formulation of the fluoroquinolone antibiotic, represents a critical segment within the injectable drug market, especially in hospital and critical care settings. Its prominence hinges on the global demand for effective antimicrobial agents amid escalating antibiotic resistance and the rising prevalence of bacterial infections. This article examines the market dynamics shaping FLOXIN IN DEXTROSE 5% and projects its financial trajectory based on current pharmaceutical industry trends, regulatory environments, and healthcare demands.

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Market Overview and Demand Drivers

Global Antimicrobial Market Growth

The global antimicrobial agents market was valued at approximately USD 55 billion in 2022 and is projected to grow at a CAGR of 3.8% through 2030 [1]. The surge in bacterial infections, especially in intensive care units (ICUs), and the increasing prevalence of multidrug-resistant organisms (MDROs) drive demand for potent injectable antibiotics like FLOXIN IN DEXTROSE 5%.

Hospital and Critical Care Utilization

Injectable antibiotics account for a substantial share of antimicrobial consumption, particularly in settings requiring immediate and effective treatment. According to the WHO, approximately 78% of antibiotics used in hospitals are administered via parenteral routes, primarily intravenous formulations [2]. This creates a steady demand for products like FLOXIN in dextrose 5%, especially in developing regions where outpatient oral therapy is limited.

Antibiotic Resistance and Stewardship

The rising incidence of antibiotic resistance bolsters the need for advanced fluoroquinolones. Infections caused by resistant strains necessitate the use of broad-spectrum agents, sustaining demand for drugs like FLOXIN. However, regulatory restrictions and stewardship programs aiming to curb overuse could impact long-term sales trajectories.

Competitive Landscape

Key Players and Market Share

Major pharmaceutical companies such as Sanofi, Teva Pharmaceuticals, and Mylan manufacture fluoroquinolone injectables, with generic versions like FLOXIN dominating cost-sensitive markets. Market entry is relatively accessible due to the generic nature of the drug, leading to intense price competition, which pressures profit margins but expands access.

Pricing Dynamics

Pricing varies globally, influenced by local regulatory policies, purchasing power, and supply chain factors. Developed markets see higher prices due to stringent regulatory standards, whereas emerging markets emphasize affordability, which constrains profitability but expands volume sales.

Regulatory Environment

Regulatory authorities like the FDA and EMA impose strict approval and post-market surveillance requirements. The approval process for generic drugs involves demonstrating bioequivalence, which is relatively straightforward. However, ongoing safety concerns about fluoroquinolones, including risks of tendinitis and neuropsychiatric effects, could lead to revised labeling or usage restrictions, impacting sales.

Market Challenges and Opportunities

Supply Chain and Manufacturing Constraints

Global supply chains for active pharmaceutical ingredients (APIs) and excipients like dextrose can face disruptions, affecting production stability for FLOXIN IN DEXTROSE 5%. Manufacturing efficiencies and strategic alliances are vital for maintaining margins.

Emerging Markets Expansion

Growth in regions like Asia-Pacific and Latin America presents significant opportunities due to expanding healthcare infrastructure and growing antibiotic demand. Strategic localization and pricing adjustments can enhance market penetration.

Innovation and New Formulations

While the existing generic formulation remains dominant, research into combination therapies and novel fluoroquinolone derivatives may pose competitive threats or open derivative markets.

Financial Trajectory Forecast

Revenue Projections

Based on current market trends, global sales of injectable fluoroquinolones are expected to reach USD 8.2 billion by 2030, with a CAGR of approximately 4%. FLOXIN IN DEXTROSE 5% is projected to mirror this growth, driven by expanding hospital use and generic sales volume increases, particularly in emerging markets.

Pricing and Volume Trends

Average selling prices (ASPs) are likely to decline by 1-2% annually due to intense generics competition. However, volume growth in emerging markets could offset price erosion, resulting in overall revenue growth.

Profitability Outlook

Profit margins are under pressure owing to commoditization. Companies leveraging economies of scale and optimized supply chains can maintain profitability. The rise in regulatory costs and stewardship restrictions may marginally dampen margins but are unlikely to prevent overall upward revenue trends.

Regulatory and Market Risks

• Regulatory Restrictions: Potential labeling updates or restrictions based on emerging safety concerns.
• Resistance Trends: Increasing resistance could limit clinical utility, necessitating formulation modifications or combination use.
• Market Entry Barriers: Regional regulatory hurdles may delay or restrict market expansion.

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Key Takeaways

• Steady Growth: FLOXIN IN DEXTROSE 5% benefits from a growing global antimicrobial market and hospital-centric antibiotic use.
• Price Competition: Intense generic competition pressures pricing but supports high-volume sales, especially in emerging markets.
• Regulatory Risks: Ongoing safety considerations and antimicrobial stewardship programs could influence future sales.
• Market Expansion: Emerging economies offer lucrative growth opportunities owing to expanding healthcare access and infrastructure.
• Supply Chain Importance: Maintaining robust manufacturing and supply chain processes is crucial amid global disruptions.

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Conclusion

FLOXIN IN DEXTROSE 5% is positioned for moderate but sustained growth over the next decade, driven by increasing bacterial infections, hospital use, and global expansion. Market dynamics favor volume growth over pricing, emphasizing manufacturing efficiency and regulatory navigation. Navigating safety risks and resistance patterns will be essential to maintaining its financial trajectory. Strategic focus on emerging markets and innovation will further enhance its market presence, supporting long-term profitability.

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FAQs

1. What are the main factors influencing the market share of FLOXIN IN DEXTROSE 5%?
Market share is primarily influenced by hospital demand, regional regulatory approvals, pricing strategies, and competition from other fluoroquinolone formulations.

2. How does antibiotic resistance impact the sales of FLOXIN?
Rising resistance can diminish clinical efficacy, potentially reducing sales unless new formulations or combination therapies are introduced. Conversely, it can also increase short-term demand as resistant infections require potent antibiotics.

3. What regions present the highest growth opportunities for FLOXIN IN DEXTROSE 5%?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa offer significant growth due to increasing healthcare infrastructure and demand for affordable injectable antibiotics.

4. How do regulatory changes affect the long-term prospects of FLOXIN?
Stringent safety regulations and stewardship policies can limit use or impose restrictions, potentially affecting sales but also encouraging safer, more targeted usage.

5. What strategic moves could pharmaceutical firms employ to maximize profitability?
Firms should focus on optimizing supply chains, expanding into new markets, maintaining regulatory compliance, and investing in clinical research to adapt to safety concerns and resistance patterns.

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Sources

[1] MarketWatch, "Global Antimicrobial Agents Market Forecast," 2022.
[2] WHO, "Antimicrobial Use in Hospitals," 2021.