FLOXIN Drug Patent Profile

Which patents cover Floxin, and when can generic versions of Floxin launch?

Floxin is a drug marketed by Ortho Mcneil Pharm, Janssen Pharms, and Daiichi. and is included in three NDAs.

The generic ingredient in FLOXIN 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

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

Summary for FLOXIN

US Patents:	0
Applicants:	3
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	149
Clinical Trials:	8
Patent Applications:	5,486
DailyMed Link:	FLOXIN at DailyMed

Recent Clinical Trials for FLOXIN

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 clinical trials

US Patents and Regulatory Information for FLOXIN

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	ofloxacin	INJECTABLE;INJECTION	020087-002	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
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990		DISCN	Yes	No

Expired US Patents for FLOXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990	4,382,892
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992	4,382,892
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990	4,382,892

International Patents for FLOXIN

See the table below for patents covering FLOXIN around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	204488
Denmark	158267
Germany	3167216

Supplementary Protection Certificates for FLOXIN

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
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	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

Market Dynamics and Financial Trajectory for FLOXIN

Last updated: July 29, 2025

Introduction

FLOXIN, a broad-spectrum quinolone antibiotic primarily containing ofloxacin, has long been entrenched in the treatment of bacterial infections such as urinary tract infections, respiratory tract infections, and skin infections. Although generic versions dominate the market due to its patent expiration in many regions, recent shifts in pharmaceutical regulations, resistance patterns, and competitive dynamics continue to influence FLOXIN’s market landscape and financial trajectory.

Current Market Landscape

Global Market Size and Trends

The global antibiotics market was valued at approximately USD 52 billion in 2022, with quinolone derivatives representing a significant segment [1]. While specific data on FLOXIN's standalone valuation remain proprietary, its sales are primarily driven by emerging markets where access to affordable generics remains pivotal. The widespread use of FLOXIN in countries such as India, China, and Brazil sustains its revenue base, despite stiff competition from newer antibiotics and alternative drug classes.

Patent and Regulatory Environment

FLOXIN’s original patent filings expired in the early 2000s, allowing multiple manufacturers to produce generic formulations. Regulatory authorities, including the FDA and EMA, now treat FLOXIN as a generic, which has led to price erosion and intensified competition [2]. Additionally, regulatory scrutiny over antibiotic stewardship has prompted restrictions on FLOXIN prescriptions in some regions, aiming to curb antimicrobial resistance (AMR).

Resistance and Clinical Efficacy Challenges

Growing antimicrobial resistance, particularly among Pseudomonas aeruginosa and Escherichia coli, has diminished FLOXIN’s clinical utility. Studies reveal increasing resistance rates—up to 20-30% in certain locales—prompting clinicians to substitute FLOXIN with newer or combination therapies [3]. Resistance not only dampens demand but also influences future investment in FLOXIN’s development pipelines.

Competitive Dynamics

FLOXIN faces intense competition from both first-generation quinolones such as ciprofloxacin and newer agents like moxifloxacin. Furthermore, the rise of alternative treatment options, including cephalosporins and macrolides, has affected its market share. Generic manufacturers have considerably driven down prices, eroding profit margins.

Financial Trajectory Analysis

Revenue Trends

The revenue for FLOXIN has shown a declining pattern over recent years. While global sales peaked in the early 2010s, the compounded annual growth rate (CAGR) has since fallen to approximately -3% between 2018 and 2022 [4]. This decline is attributable to patent expirations, rising resistance, and restrictive prescribing policies.

Profitability and Cost Structure

Generic manufacturers benefits from lower production costs, allowing margins to remain relatively healthy despite falling prices. However, manufacturers are increasingly investing in marketing efforts, overcoming regulatory hurdles, and updating formulations to maintain competitiveness. Companies report gross margins hovering around 45-50%, but net margins are compressed due to regulatory compliance costs and market saturation.

Future Financial Outlook

Analysts project continued decline in FLOXIN revenues over the next 5 years unless leveraged through strategic repositioning. Potential options include developing combination therapies, exploring new indications, or investing in formulation improvements that counter resistance issues.

Impact of Antimicrobial Stewardship Programs

Global initiatives aiming to curb antibiotic misuse are anticipated to further restrain FLOXIN’s growth prospects. Countries like the US and several European nations have implemented stricter prescribing guidelines, impacting sales channels [5].

Market Opportunities and Threats

Opportunities

• Emerging Markets Growth: Increased healthcare access and growing bacterial infection prevalence in emerging markets sustain demand.
• Development of Novel Formulations: Creating formulations with enhanced bioavailability or targeting resistant strains offers growth avenues.
• Strategic Alliances: Partnering with biotech firms to innovate or extend patent life can provide financial uplift.

Threats

• Rising Resistance Rates: Accelerating resistance diminishes clinical effectiveness and reduces demand.
• Regulatory Push for Antibiotic Stewardship: Stricter prescribing policies may constrain sales volumes.
• Market Saturation: An oversupply of generic quinolones intensifies price wars, reducing profitability.

Strategic Outlook

To stabilize or enhance its financial trajectory, FLOXIN manufacturers must focus on:

• Innovation: Developing formulations addressing resistance challenges.
• Geographic Diversification: Tapping into underserved markets with high infection rates.
• Regulatory Engagement: Collaborating with authorities to ensure continued clinical utility and compliance.
• Antimicrobial Stewardship: Implementing educational campaigns to optimize use and preserve drug efficacy.

Key Takeaways

• The FLOXIN market is characterized by declining revenues driven by patent expiration, resistance escalation, and regulatory restrictions.
• Its standing is challenged by newer antibiotics offering improved efficacy and safety profiles.
• Markets in emerging economies present growth opportunities, provided strategic adaptations are undertaken.
• Long-term profitability depends on innovation, diversification, and proactive regulatory engagement.
• The global focus on antimicrobial resistance necessitates prudent use, which will continue to influence FLOXIN’s market dynamics.

FAQs

1. How has antimicrobial resistance impacted FLOXIN’s market?
Rising resistance rates have reduced FLOXIN’s effectiveness against certain bacterial strains, leading to decreased prescribing, lower sales volumes, and the need for formulations targeting resistant pathogens.

2. Are there any new formulations of FLOXIN in development?
While some manufacturers are exploring combination therapies and formulations with improved pharmacokinetics, no recent significant innovation specific to FLOXIN has been publicly announced.

3. Which regions are most promising for FLOXIN sales?
Emerging markets, such as India, China, and Latin America, remain key regions due to high infection burdens, limited access to newer antibiotics, and ongoing reliance on generics.

4. Will regulatory restrictions diminish FLOXIN’s future prospects?
Yes. Tightening prescribing policies and stewardship programs will likely constrain its usage unless firms adapt through innovation or market differentiation.

5. What strategic actions should manufacturers consider for FLOXIN’s sustainability?
Investing in R&D for resistance-countering formulations, expanding into emerging markets, fostering regulatory collaborations, and promoting responsible use are vital strategies.

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References

[1] MarketsandMarkets, "Antibiotics Market," 2022.
[2] FDA Guidance on Generic Drug Approvals, 2021.
[3] WHO Antimicrobial Resistance Global Report, 2022.
[4] IQVIA, "Global Antibiotics Sales Data," 2022.
[5] CDC Antimicrobial Stewardship Program Reports, 2022.