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
Oregon Health and Science University	Phase 4
University of California, San Francisco	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
Finland	812693
Philippines	18276	BENZOXAZINE DERIVATIVES AND PROCESS OF PREPARATION
Yugoslavia	42422
Slovenia	8112109	PROCESS FOR PREPARING THE COMPOUNDS 9-HALO-7-OXO-2, 3-DIHYDRO-7H-PYRIDO (1,2,3-DE) (1,4) BENZOXAZINE-6-CARBOXYLIC-ACID

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

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1429780	132013902137451	Italy		PRODUCT NAME: CIPROFLOXACINA E DESAMETASONE(CILODEX); AUTHORISATION NUMBER(S) AND DATE(S): 48976, 20120810;041182015/M, 20121106
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
0413455	98C0040	Belgium		PRODUCT NAME: ALATROFLOXACIN; NAT. REGISTRATION NO/DATE: EU/1/98/060/001 19980327; FIRST REGISTRATION: CH 54484 19980327
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	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

FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER Market Analysis and Financial Projection

Last updated: February 10, 2026

What Is the Current Market Position of FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER?

FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER primarily functions as a fluoroquinolone antibiotic administered typically for bacterial infections in intravenous form. It is marketed by pharmaceutical companies for hospital and clinical use. The product's mode of delivery—intravenous infusion—limits its application exclusively to inpatient and emergency care settings.

This formulation is a branded or generic version of ciprofloxacin solutions, with the combination of fluoroquinolone activity and a dextrose carrier designed for parenteral therapy. As of 2023, it competes within the broader IV antibiotic market, valued globally at approximately $8 billion and projected to grow at a compounded annual growth rate (CAGR) of 4-6% through 2028 [1].

What Are the Market Drivers and Constraints?

Drivers

• Hospital Infections: Rising prevalence of hospital-acquired infections increases demand for IV antibiotics like FLOXIN.
• Antibiotic Resistance Management: Ciprofloxacin’s efficacy against a broad spectrum of bacteria makes it a preferred choice in susceptible cases.
• Regulatory Approvals: ANVISA (Brazil), FDA (US), and EMA (Europe) approvals secure access to large markets.
• Increased Use of IV Therapies: Shift towards parenteral treatments in infections, especially for severe cases.

Constraints

• Antibiotic Stewardship Programs: Focus on limiting use of broad-spectrum antibiotics to avoid resistance diminishes market growth.
• Competition from Generics: Numerous generic ciprofloxacin IV formulations are available, pressuring pricing.
• Limitations in Outpatient Use: IV formulations restrict use to inpatient settings, curbing market expansion.

How Has the Sales Trajectory Evolved?

Global sales of IV ciprofloxacin solutions like FLOXIN are estimated at $450-$600 million annually, with regional contributions:

Region	Market Share	Estimated Sales (2022)	CAGR (2022–2027)
North America	45%	$202.5 million	3%
Europe	30%	$135 million	3-4%
Asia-Pacific	20%	$90 million	6%
Others	5%	$22.5 million	5%

Sales growth has been steady but not exceptional, reflecting market maturity. Revenues plateau when generic competition and stewardship programs suppress volume.

What Are the Financial Outlooks and Investment Opportunities?

Revenue Streams

• Direct Sales: Primarily to hospitals and healthcare providers.
• Contract Manufacturing: Outsourcing production to optimize margins.
• Regulatory Approvals: Potential revenue from line extensions or indications.

Profitability Considerations

• Pricing: Competitive pressures reduce gross margins; IV formulations achieve roughly 15-20% profit margins.
• Market Share: Limited growth in developed markets due to stewardship; expanding in emerging markets remains challenging.
• Patent Status: Likely off-patent; generic competition intensifies pricing erosion.

Future Trends

• Emergence of Resistance: Raises the need for new antibiotics, potentially shrinking the market.
• Innovation: Fixed-dose combinations or new delivery systems could create niche markets.
• Regulatory Shifts: Moves toward narrower antibiotic use could impact volume.

How Do Competitive Products Stack Up?

Product	Delivery Format	Sales (2022)	Key Attributes
Ciprofloxacin IV (generic)	Intravenous	$350 million	Cost-effective, widespread use
Levofloxacin IV (brand & generic)	Intravenous	$200 million	Broader spectrum, newer formulation
Other fluoroquinolones	Oral & IV	Varies	Substitutes and complements

The market structure favors generics with aggressive pricing strategies, constraining the profitability of branded products like FLOXIN.

How Are Regulatory Policies Affecting Market Dynamics?

• Antibiotic Stewardship: Policies promote judicious use, especially of broad-spectrum agents.
• Approval in Emerging Markets: Offers growth avenues but involves compliance costs.
• Environmental Regulations: Stringent controls on antibiotic residues can affect manufacturing and disposal policies.

Key Takeaways

• The IV ciprofloxacin market is sizable, mature, and consolidating.
• Fluoroquinolone resistance and stewardship policies moderate growth.
• Generic competition exerts significant pressure on pricing and margins.
• Expansion into emerging markets and niche indications may offer growth potential.
• New formulations or combination therapies could rejuvenate interest but face regulatory hurdles.

FAQs

1. What is the primary competitive advantage of FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER?
Its established efficacy, regulatory approvals, and hospital familiarity offer advantages, but price competitiveness with generics diminishes its market share.

2. How does resistance impact the future of the IV ciprofloxacin market?
Resistance development reduces clinical efficacy, leading to decreased demand and a shift toward newer agents or combination therapies.

3. Are there opportunities for patent extension or line extensions for FLOXIN?
Limited; off-patent status of ciprofloxacin restricts patent protections. Line extensions may involve new formulations or delivery systems.

4. What regions hold the most promise for growth?
Emerging markets in Asia and Latin America; regulatory approvals there can expand patient access despite economic and logistical challenges.

5. How might new regulations influence the use of IV antibiotics like FLOXIN?
Policies aiming to reduce unnecessary antibiotic use could limit hospital prescribing, affecting sales volumes.

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References

[1] IQVIA. "Global Antibiotics Market Report," 2023.