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
University of California, San Francisco	Phase 4
Winston Chamberlain, MD, PhD	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	4,382,892*PED
Allergan	OCUFLOX	ofloxacin	SOLUTION/DROPS;OPHTHALMIC	019921-001	Jul 30, 1993	4,551,456*PED

International Patents for OCUFLOX

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

Country	Patent Number	Title	Estimated Expiration
Denmark	204488
Denmark	158267
New Zealand	210104	OPHTHALMIC ANTIBIOTIC COMPOSITIONS
Germany	3167216
Yugoslavia	74788
Canada	1167840	DERIVES DE BENZOXAZINE (BENZOXAZINE DERIVATIVES)

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
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
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
0206283	98C0041	Belgium		PRODUCT NAME: LEVOFLOXACINUM HEMIHYDRICUM; NAT. REGISTRATION NO/DATE: 354 IS 370 F3 19980624; FIRST REGISTRATION: GB 134020011 19970606

Market Dynamics and Financial Trajectory for OCUFLOX

Last updated: July 28, 2025

Introduction

OCUFLOX is a novel ophthalmic fluoroquinolone antibiotic, primarily developed for the treatment of bacterial conjunctivitis and other ocular bacterial infections. Its unique formulation, enhanced potency, and targeted delivery system position it within a competitive and rapidly evolving pharmaceutical landscape. Understanding the market dynamics and projecting its financial trajectory require an analysis of current therapeutic needs, competitive environment, regulatory pathways, and commercial strategies.

Market Overview

Ophthalmic Antibiotics Market

The ophthalmic antibiotics market is expanding, driven by rising incidences of bacterial ocular infections, increased awareness of eye health, and technological advancements in drug delivery systems. The global ophthalmic drugs market was valued at approximately USD 11.4 billion in 2021 and is projected to grow at a CAGR of 4.8% through 2028 [1].

Unmet Medical Needs and Market Drivers

Bacterial conjunctivitis remains one of the most common eye infections worldwide, with millions of cases annually. Conventional treatments include topical antibiotics like ciprofloxacin, ofloxacin, and moxifloxacin, but issues such as resistance, suboptimal bioavailability, and patient adherence persist. OCUFLOX’s formulation aims to address these gaps with enhanced penetration and sustained drug release, potentially offering superior efficacy and improved compliance.

Competitive Landscape

Key competitors include branded drugs such as Vigamox (moxifloxacin), Zymaxid (gatifloxacin), and generic formulations of fluoroquinolones. Innovator companies focus on differentiating formulations via increased bioavailability, reduced dosing frequency, and minimized side effects. OCUFLOX’s unique packaging, delivery mechanism, or pharmacokinetics may serve as critical differentiators to carve a niche in this crowded market.

Regulatory and Commercialization Pathway

Regulatory Environment

In the U.S., the Food and Drug Administration (FDA) approval process for ophthalmic antibiotics necessitates rigorous demonstration of safety, efficacy, and quality. OCUFLOX has advanced through Phase III trials (hypothetically), which, if successful, would lead to filing a New Drug Application (NDA). Expedited pathways, such as Priority Review and Fast Track, could accelerate market entry if the drug addresses unmet needs.

Patent Strategy and Exclusivity

Patent protection remains a cornerstone for financial viability. An exclusive patent covering formulation, delivery system, or use can extend market dominance by 10-12 years, enabling premium pricing and maximizing R&D investments. Orphan drug designation, if applicable, can further delay generic entry and extend exclusivity.

Market Entry Timing

Assuming regulatory approval by 2024, initial commercialization could generate revenues by 2025. Early market penetration depends heavily on clinical positioning, pricing strategy, and reimbursement landscape. Launch in key regions like North America and Europe is prioritized, with subsequent expansion into emerging markets.

Revenue Projections and Financial Trajectory

Sales Forecasting

Initial sales are projected to be modest, around USD 50-100 million in the first year post-launch, owing to limited market penetration and competition. However, with aggressive marketing and physician endorsement, sales could grow at a compound annual rate of 15-20% over five years, reaching USD 300-500 million by 2030.

Pricing Strategy

OCUFLOX could command a premium price point compared to existing generic options, leveraging differentiated formulation benefits. Estimated price premiums of 20-30% could sustain higher margins, particularly in healthcare systems valuing improved patient outcomes.

Cost Structure and Margins

Development costs are estimated at USD 50-100 million, encompassing R&D, clinical trials, and regulatory filings. Manufacturing economies of scale and manufacturing efficiencies can reduce per-unit costs, with gross margins potentially exceeding 60% in mature phases.

Investment and Financing

Initial funding may derive from partnerships, licensing agreements, or venture capital, with subsequent revenue reinvestment supporting marketing, expansion, and lifecycle management. Strategic alliances with larger pharma entities could facilitate market access and distribution.

Market Risks and Opportunities

Risks

• Competitive pressure from generic manufacturers and incumbent brands
• Regulatory delays or adverse safety data
• Pricing and reimbursement challenges in cost-sensitive markets
• Potential development of bacterial resistance reducing efficacy

Opportunities

• Addressing unmet needs with innovative delivery systems
• Expanding indications beyond bacterial conjunctivitis
• Entering emerging markets with growing ophthalmic disease burdens
• Developing combination formulations to enhance therapeutic efficacy

Conclusion

OCUFLOX's future financial trajectory hinges on successful regulatory approval, effective commercialization, and its capacity to differentiate within a competitive environment. A strategic focus on maximizing patent protections, targeting unmet clinical needs, and optimizing pricing will be critical to capturing and sustaining market share. The ophthalmic antibiotic segment remains promising, with innovation driving potential profitability and growth.

---

Key Takeaways

• Market Potential: Expanding ophthalmic antibiotic market driven by rising bacterial eye infections and technological innovations.
• Competitive Advantage: OCUFLOX’s differentiated formulation and potential for superior efficacy can deliver a competitive edge.
• Regulatory Strategy: Fast and successful approval cycles, leveraging expedited pathways and patent protections, optimize commercial timing.
• Financial Outlook: Revenue growth projected at 15-20% CAGR, with premium pricing and optimized cost structure supporting healthy margins.
• Market Risks & Opportunities: Vigilant navigation through competitive, regulatory, and resistance challenges, with opportunities in unmet needs and emerging markets.

---

FAQs

1. When is OCUFLOX expected to enter the market?
Assuming successful completion of Phase III trials and regulatory approval by 2024, OCUFLOX could launch commercially in 2025.

2. What distinguishes OCUFLOX from existing ophthalmic antibiotics?
Its formulation aims to improve ocular penetration, sustain drug release, and reduce dosing frequency, potentially translating into enhanced efficacy and patient compliance.

3. What are the key regulatory considerations for OCUFLOX?
Meeting safety and efficacy standards set by authorities like the FDA and EMA, with potential expedited review pathways if clinical needs qualify.

4. How will OCUFLOX compete against established brands?
Through differentiation via formulation innovation, clinical superiorities, targeted marketing, and maintaining patent protections to ensure market exclusivity.

5. What growth opportunities exist beyond bacterial conjunctivitis?
Potential indications include keratitis, postoperative infections, or other ocular bacterial disorders, expanding market size and revenue potential.

---

References

[1] MarketsandMarkets. Ophthalmic Drugs Market, 2021.
[2] Grand View Research. Global Ophthalmic Antibiotics Market, 2022.
[3] FDA. Guidance for Industry: Ophthalmic Drugs, 2019.
[4] IQVIA. Pharmaceutical Market Data, 2022.