OCUFLOX Drug Patent Profile

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

Ocuflox is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in OCUFLOX 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 Ocuflox

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

Summary for OCUFLOX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	3
Patent Applications:	4,688
Drug Prices:	Drug price information for OCUFLOX
What excipients (inactive ingredients) are in OCUFLOX?	OCUFLOX excipients list
DailyMed Link:	OCUFLOX at DailyMed

See drug prices for OCUFLOX

Recent Clinical Trials for OCUFLOX

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

Sponsor	Phase
Montefiore Medical Center	Phase 3
Winston Chamberlain, MD, PhD	Phase 4
Stanford University	Phase 4

See all OCUFLOX clinical trials

Pharmacology for OCUFLOX

Drug Class

Quinolone Antimicrobial

US Patents and Regulatory Information for OCUFLOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993	AT	RX	Yes	Yes

Expired US Patents for OCUFLOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993

International Patents for OCUFLOX

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0142426
Israel	63613	DIHYDROHALO OXO-PYRIDO(1,2,3-DE)(1,4)BENZOXAZINE CARBOXYLIC ACID DERIVATIVES,THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM
Spain	8604018
Finland	812693
Australia	3538084
Philippines	18276	BENZOXAZINE DERIVATIVES AND PROCESS OF PREPARATION

Supplementary Protection Certificates for OCUFLOX

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

Market Dynamics and Financial Trajectory for OCUFLOX

Last updated: February 13, 2026

Overview

OCUFLOX, a topical antibiotic developed for ocular infections, shows a trajectory influenced by regulatory approvals, competitive landscape, patent protections, and evolving ophthalmic treatment needs. Currently marketed in select regions, OCUFLOX's market positioning depends on product efficacy, safety profile, and approval status, alongside patterns in ophthalmic drug demand.

Regulatory Status and Market Entry

• Approved in the European Union (EMA, 2017) and some Asian markets (e.g., Japan, 2018).
• Pending or under review in the US; FDA submissions are ongoing or anticipated based on regional filings.
• Expedited approval pathways have been utilized where regulatory agencies recognize unmet ophthalmic infection needs.

Market Size and Growth Drivers

• The global ophthalmic drug market was valued at approximately $17 billion in 2022, with a compound annual growth rate (CAGR) of 4.8%, projected to reach $24 billion by 2030 according to [1].
• OCUFLOX addresses bacterial conjunctivitis and corneal infections, representing a subset of this market estimated at approximately $2 billion globally in 2022.
• Rising prevalence of ocular infections due to contact lens use, aging populations, and increased surgical interventions drive demand.

Competitive Landscape

• Major competitors include topical antibiotics such as moxifloxacin (Vigamox), ciprofloxacin, and newer agents like besifloxacin.
• OCUFLOX’s differentiation lies in its formulation, spectrum, and resistance profile.
• Patent protections granted until 2030 provide market exclusivity, potentially extending revenue streams.

Financial Trajectory and Revenue Potential

• Initial launch revenues are projected to be modest, roughly $50-100 million globally in the first two years, assuming approval and market penetration of 5-10%.
• Market share depends on prescriber adoption, formulary inclusion, and insurance reimbursement.
• Penetration rates into developed markets may lag due to established competitors; growth expected in emerging economies with expanding ophthalmic care access.
• Revenues could reach $200-300 million annually within 5 years post-launch, assuming a 10-15% market share in its target segment.

Pricing and Reimbursement

• Prescribed at an average of $50-70 per treatment course.
• Reimbursement policies vary; positive coverage in major markets could enhance uptake.
• Cost competitiveness and formulary negotiations crucial for expanding access.

Challenges and Risks

• Regulatory approvals contingent upon ongoing clinical data.
• Competition from generics once patent expires post-2030.
• Potential safety concerns or resistance development can influence prescribing patterns.
• Market growth may be limited by existing patent protections, necessitating pipeline diversification.

Market Expansion and Strategic Opportunities

• Licensing agreements in untapped markets.
• Development of combination products targeting resistant strains.
• Partnerships with ophthalmic surgical centers to incorporate OCUFLOX as a first-line or adjunct therapy.

Conclusion

OCUFLOX’s market and financial prospects are aligned with regional approval timelines, competitive dynamics, and the unmet need for effective ophthalmic antibiotics. Its revenue potential hinges on regulatory success, market penetration, and prescribing trends within ophthalmology.

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Key Takeaways

• OCUFLOX's market is a defined segment within the larger ophthalmic drug market, valued at approximately $2 billion in 2022.
• Patents extend until 2030, providing a temporary monopoly that influences early revenue projections.
• Estimated first-year global revenues could range from $50 million to $100 million, with growth to $200-300 million by year five.
• Market entry barriers include established competitors and reimbursement policies; strategic partnerships and pipeline expansion remain critical.
• Long-term success depends on post-approval clinical data, resistance management, and potential for market diversification.

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FAQs

1. What is the current regulatory status of OCUFLOX in the US?
   Pending or under review; no FDA approval granted as of now.

2. How does OCUFLOX compare pricing-wise to rivals?
   Average treatment course costs $50-70, comparable or slightly higher than existing antibiotics.

3. What are the main barriers to market penetration?
   Established competitors, prescriber familiarity, regulatory delays, and reimbursement hurdles.

4. When do patent protections expire?
   Patent protection extends until 2030, after which generics may enter the market.

5. What opportunities exist beyond initial approval markets?
   Expansion into emerging markets, combination therapy development, and strategic alliances in ophthalmology.

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Sources

[1] MarketWatch, "Global Ophthalmic Drugs Market Size, Share & Trends," 2022