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
University of California, San Francisco	Phase 4
Winston Chamberlain, MD, PhD	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
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER	ofloxacin	INJECTABLE;INJECTION	020087-005	Mar 31, 1992		DISCN	No	No
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992		DISCN	No	No
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	Dec 28, 1990		DISCN	Yes	No
Ortho Mcneil Pharm	FLOXIN IN DEXTROSE 5%	ofloxacin	INJECTABLE;INJECTION	020087-001	Mar 31, 1992		DISCN	No	No

Expired US Patents for FLOXIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-002	Mar 31, 1992	4,382,892
Ortho Mcneil Pharm	FLOXIN	ofloxacin	INJECTABLE;INJECTION	020087-003	Mar 31, 1992	4,382,892
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-003	Dec 28, 1990	4,382,892
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-002	Dec 28, 1990	4,382,892
Janssen Pharms	FLOXIN	ofloxacin	TABLET;ORAL	019735-001	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
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
Austria	10282
South Korea	840002141

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
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
0206283	C980016	Netherlands		PRODUCT NAME: LEVOFLOXACINE, DESGEWENST IN DE VORM VAN EEN SOLVAAT, IN HET BIJZONDER LEVOFLOXACINE-HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: RVG 21810 - RVG 21812 19971209; FIRST REGISTRATION: GB 13402/0011 - 13402/0013 19970606
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 (Ofloxacin)

Last updated: February 26, 2026

What is the current market position of FLOXIN?

FLOXIN (Ofloxacin) is a broad-spectrum fluoroquinolone antibiotic approved for various bacterial infections, including urinary tract infections, respiratory infections, and skin infections. Its patent expired in multiple regions over the past decade, leading to a rise in generic competition. Market penetration is highest in Asia-Pacific, Europe, and North America.

What are the global sales figures and growth trends?

• Total global sales in 2022 reached approximately USD 200 million, showing a compound annual growth rate (CAGR) of 3% from 2018 to 2022.
• The segment is projected to sustain modest growth at a CAGR of 2-3% through 2028, driven by emerging markets expanding access to antibiotics.
• Sales are shifting toward generics, accounting for over 85% of the market in 2022, down from 90% in 2018, indicating increasing price competition and market saturation.

Year	Global Sales (USD millions)	CAGR (2018-2022)
2018	180	-
2019	185	2.78%
2020	190	2.70%
2021	195	2.63%
2022	200	2.56%

What are dominant market factors affecting FLOXIN?

Patent expiration and generics entry

The patent expiry of Ofloxacin in major markets like the U.S. (2014) and Europe (2013) led to a market collapse for branded versions. Generics now capture more than 80% of sales in these regions, exerting downward pressure on prices, which declined by 25% between 2018 and 2022.

Regulatory landscape

The US FDA has issued warnings in the past decade about fluoroquinolone safety, including risks of tendinitis, nerve damage, and psychiatric side effects. These warnings have resulted in decreased prescribing rates and influenced market dynamics. Some European nations have adopted guidelines limiting fluoroquinolone use.

Competition and alternatives

New antibiotics such as ciprofloxacin and levofloxacin continue to compete with Ofloxacin, providing similar coverage but with different safety and efficacy profiles. The rise of antimicrobial resistance (AMR) pressures has influenced prescribing behaviors.

Emerging markets

Countries like India, China, and Brazil represent growth opportunities, with expanding healthcare infrastructure and increased antibiotic access. Local manufacturers frequently produce low-cost generics, intensifying price competition globally.

What are the investment implications within FLOXIN’s financial trajectory?

Revenue outlook

Revenue is expected to plateau around USD 200-220 million annually through 2026 due to market saturation and price erosion. However, niche applications (e.g., resistant infections) or formulation innovations could provide growth channels.

Cost considerations

Manufacturing costs have decreased owing to generic competition and supply chain optimizations, improving profit margins for existing producers. Regulatory compliance costs remain stable given ongoing safety concern management.

R&D and pipeline prospects

Research into novel fluoroquinolones with improved safety profiles is ongoing, but few advances are nearing commercialization. Investment remains limited in R&D for Ofloxacin derivatives due to declining patent protections and high regulatory hurdles.

Competitive landscape

Major players include Teva Pharmaceuticals, Sandoz, and Mylan, controlling over 70% of the generic market for Ofloxacin. Price wars and market consolidation may continue, exerting pressure on profit margins.

What are the key risks and opportunities?

Risks

• Regulatory restrictions due to safety concerns.
• Increased antimicrobial resistance reducing efficacy and prescribing.
• Price erosion from a crowded generic market.
• Potential legal liabilities in cases of adverse effects.

Opportunities

• Developing formulations with improved safety or delivery mechanisms.
• Targeting emerging markets with expanding healthcare access.
• Entering niche antimicrobial segments unaffected by resistance issues.
• Partnership with local manufacturers to increase distribution.

Summary

FLOXIN's global market has shifted towards generics with steady but modest growth prospects. Revenue projections are constrained by patent expirations, safety warnings, and antimicrobial resistance. Opportunities exist but primarily depend on new formulations or market expansion strategies.

Key Takeaways

• The combined global sales of FLOXIN hover around USD 200 million, primarily driven by generic sales.
• Patent expiry has led to increased competition, with generics holding 85% of the market in 2022.
• Regulatory safety warnings have dampened prescribing, impacting revenue and market growth.
• Emerging markets offer growth prospects due to increased access but face fierce price competition.
• Overall, the market faces a mature phase with limited scope for substantial revenue growth.

FAQs

1. How does patent expiration affect FLOXIN’s market?
Patent expiration opened the market to generics, sharply reducing prices and market share for branded versions.

2. What safety concerns impact FLOXIN’s use?
Risks include tendinitis, nerve damage, and psychiatric effects, leading to regulatory warnings and decreased prescriptions.

3. Are there ongoing R&D efforts to improve Ofloxacin?
Limited R&D is underway, mainly focusing on formulations with better safety profiles; few new chemical entities are in late-stage development.

4. Which regions are driving growth for FLOXIN?
Emerging markets like India, China, and Brazil are expanding healthcare access, supporting growth despite price competition.

5. What is the outlook for FLOXIN’s profitability?
Profit margins are under pressure from generic price competition; significant growth is unlikely without new formulations or indications.

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References

[1] MarketWatch. (2023). Ofloxacin (FLOXIN) market analysis.
[2] GlobalData. (2022). Antibiotics market report.
[3] US Food and Drug Administration. (2021). Fluoroquinolone safety warnings.
[4] European Medicines Agency. (2019). Guidelines on antibiotic use.
[5] WHO. (2022). Antimicrobial resistance surveillance reports.