FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile

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

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

The generic ingredient in FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER 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% In Plastic Container

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

Summary for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Recent Clinical Trials for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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% IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for FLOXIN 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
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% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-004	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992	4,382,892

International Patents for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

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

Country	Patent Number	Title	Estimated Expiration
Israel	63613	DIHYDROHALO OXO-PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE CARBOXYLIC ACID DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Croatia	P930087
Hong Kong	82186	BENZOXAZINE DERIVATIVES
South Africa	8105604
Greece	74637

Supplementary Protection Certificates for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
0206283	SPC/GB97/085	United Kingdom		PRODUCT NAME: LEVOFLOXACIN, OPTIONALLY IN THE FORM OF A HEMIHYDRATE; REGISTERED: UK 13402/0011 19970606; UK 13402/0012 19970606; UK 13402/0013 19970606
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
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

Market Dynamics and Financial Trajectory for FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: July 27, 2025

Introduction

FLOXIN (ciprofloxacin) in dextrose 5% infusion, packaged in plastic containers, serves a vital role in antimicrobial therapy, especially in hospital and outpatient settings. Its unique formulation—intravenous ciprofloxacin in dextrose—addresses specific clinical needs, such as infections requiring IV administration. Understanding its market dynamics and financial trajectory entails analyzing factors like clinical demand, regulatory environment, manufacturing costs, competitive landscape, and evolving healthcare policies.

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Market Overview

Clinical and Therapeutic Demand

FLOXIN in dextrose 5% primarily targets bacterial infections requiring parenteral antibiotic therapy. Its broad-spectrum efficacy against gram-negative and gram-positive bacteria increases its clinical utility, especially in severe infections like pneumonia, urinary tract infections, and intra-abdominal infections[^1].

The rising prevalence of multi-drug resistant infections bolsters demand for advanced antibiotics, including ciprofloxacin formulations. Additionally, the increasing adoption of outpatient parenteral antimicrobial therapy (OPAT) protocols expands usage outside traditional inpatient settings, potentially boosting sales volumes[^2].

Market Size and Penetration

Globally, the intravenous antibiotic market is projected to reach USD 22 billion by 2027, with ciprofloxacin occupying a significant share due to its established efficacy and safety profile[^3]. The inclusion of FLOXIN in dextrose 5% addresses specific needs where rapid infusion and stability in dextrose solutions are preferred.

In emerging markets, especially in Asia-Pacific and Latin America, the expansion of healthcare infrastructure and antimicrobial stewardship efforts amplify demand. Developed regions continue to see growth driven by hospital-acquired infections and aging populations.

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Market Drivers

Clinical Efficacy and Adoption

The proven efficacy, especially against resistant bacterial strains, positions ciprofloxacin as a preferred choice. Its stability in dextrose solutions facilitates ease of administration, encouraging broader adoption[^4].

Healthcare Infrastructure and Capacity Expansion

Increasing hospital admissions, investments in healthcare infrastructure, and expanding outpatient services contribute to higher demand for IV antibiotics like FLOXIN.

Regulatory Approvals and Guidelines

Post-approval labeling, inclusion in clinical guidelines, and marked endorsements support market penetration. Regulatory agencies' fast-track approvals and streamlined manufacturing processes further facilitate market access[^5].

Growing Prevalence of Healthcare-Associated Infections (HAIs)

Rising HAIs necessitate effective antimicrobial therapy. Antibiotics compatible with existing infusion protocols in hospital settings drive market growth.

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Market Challenges and Restraints

Antimicrobial Stewardship and Resistance

Global efforts to curb antibiotic misuse and resistance threaten market volume. Stringent guidelines limit overuse, potentially constraining growth[^6].

Pricing Pressures and Reimbursement Policies

Healthcare payers and government agencies increasingly negotiate prices, especially in markets with strict formulary controls. This impacts revenue potential for high-cost formulations.

Competition from Oral and Alternative Therapies

The availability of oral formulations and newer antibiotics with broader spectra or improved safety profiles challenge the demand for IV ciprofloxacin. The shift towards oral therapy when feasible reduces reliance on parenteral forms[^7].

Manufacturing and Supply Chain Risks

Supply chain disruptions, especially for starting materials and packaging components, could impact availability and costs.

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Competitive Landscape

Key Players

Major pharmaceutical companies, including Bayer, generic manufacturers, and regional players, produce ciprofloxacin formulations. Brand dominance often correlates with existing hospital contracts and formulary preferences.

Innovations and Differentiation

Technological advancements, such as ready-to-administer formulations, improved stability, and packaging innovations (e.g., tamper-evident plastic containers), provide competitive edges.

Regulatory and Patent Expiry Impacts

Patent expirations allow generic manufacturers to produce cost-effective alternatives, intensifying price competition and pressuring margins for branded versions like FLOXIN.

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Financial Trajectory and Revenue Outlook

Revenue Trends

Historically, CIPROFLOXACIN’s revenue has experienced moderate growth, aligned with infection rates and resistance trends[^8]. The formulation in dextrose 5% in plastic containers, commonly prescribed in hospital settings, aligns with steady institutional procurement.

Pricing Dynamics

Price erosion driven by generic competition and negotiation pressures results in declining per-unit revenues in mature markets. On the other hand, premium formulations or stability improvements may command higher prices, influencing margins.

Emerging Markets Growth Potential

Increased healthcare access, government investment, and rising infection burdens forecast a compound annual growth rate (CAGR) of approximately 4%–6% over the next five years in emerging markets[^9].

Impact of Regulatory and Policy Changes

Stringent antimicrobial stewardship programs, particularly in developed economies, could dampen volume growth but incentivize innovation and formulation improvements that command premium pricing.

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Regulatory and Legal Factors

Approval Pathways

Strict adherence to FDA, EMA, and other regional regulatory standards ensures market access but entails significant costs and timelines. Recent approvals or expanded indications influence revenue streams directly.

Intellectual Property and Patent Landscape

Patent expirations in key markets open opportunities for generics but challenge existing revenue models. Enforcement of patents and legal actions impact competition.

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Future Outlook and Strategic Considerations

• Innovation in Formulation and Delivery: Development of ready-to-use, stability-enhanced formulations in plastic containers can capture niche markets and command premium pricing.

• Expansion in Antimicrobial Stewardship-Compatible Products: Aligning with policies to mitigate resistance while maintaining profitability is crucial.

• Strategic Partnerships and Contracts: Leveraging hospital procurement agreements, especially in emerging markets, sustains steady revenue streams.

• Digital and Supply Chain Optimization: Enhancing production efficiencies and leveraging data analytics can improve margins amidst competitive pressures.

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Key Takeaways

• Demand for intravenous ciprofloxacin formulations remains steady, supported by clinical efficacy and hospital adoption, but faces headwinds from antimicrobial stewardship policies.

• Market growth is particularly promising in emerging markets, driven by increasing healthcare infrastructure and infection prevalence.

• Price competition and generic proliferation exert downward pressure on revenues, necessitating differentiation through formulation innovations.

• Regulatory environments continue to shape market access, with patent expiries favoring generics but also prompting patent challenges.

• Strategic focus on innovation, supply chain resilience, and alignment with healthcare policies will determine financial success over the coming years.

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FAQs

1. What factors influence the demand for FLOXIN in dextrose 5% in plastic containers?
Demand is primarily driven by infection prevalence, clinical guidelines endorsing ciprofloxacin, hospital procurement practices, and compatibility with infusion protocols. Resistance patterns and antimicrobial stewardship policies also influence prescribing behaviors.

2. How does antimicrobial resistance impact the market trajectory of FLOXIN?
Rising resistance diminishes efficacy, potentially reducing demand for ciprofloxacin in resistant infections. Conversely, ciprofloxacin’s role in managing susceptible infections sustains some level of ongoing demand, especially when resistance is limited.

3. What role do regulatory agencies play in shaping the sales of this formulation?
Regulatory approvals enable market access, while stringent standards and licensing requirements can delay or limit uptake. Policy shifts, such as restrictions on antibiotic use, directly influence sales volumes.

4. How does competition from generics affect the financial outlook?
Patent expirations and the proliferation of generic ciprofloxacin formulations intensify price competition, reducing margins and impacting revenue growth for branded products like FLOXIN.

5. What strategies could manufacturers use to sustain growth amid market challenges?
Innovation in formulation and packaging, engaging in regional partnerships, aligning with antimicrobial stewardship initiatives, and diversifying indications or formulations will be key strategies.

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References

1. [1] World Health Organization. Antimicrobial resistance fact sheet. 2021.
2. [2] MarketResearch.com. Global IV Antibiotics Market Analysis. 2022.
3. [3] Fortune Business Insights. Intravenous Antibiotics Market Size & Industry Analysis. 2022.
4. [4] Journal of Antimicrobial Chemotherapy. Ciprofloxacin Stability in Infusion Solutions. 2020.
5. [5] U.S. Food and Drug Administration. Regulatory Guidance for Antibiotic Approvals. 2021.
6. [6] CDC. Antimicrobial Stewardship Program Antibiotic Use. 2022.
7. [7] Medicines Management. Oral vs. IV Antibiotics: Trends and Data. 2021.
8. [8] IQVIA. Ciprofloxacin Market Performance Report. 2022.
9. [9] McKinsey & Company. Emerging Market Healthcare Growth Dynamics. 2021.