Ozenoxacin - Generic Drug Details

What are the generic drug sources for ozenoxacin and what is the scope of freedom to operate?

Ozenoxacin is the generic ingredient in one branded drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ozenoxacin has thirty-seven patent family members in twenty-three countries.

There is one drug master file entry for ozenoxacin.

Summary for ozenoxacin

International Patents:	37
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	321
What excipients (inactive ingredients) are in ozenoxacin?	ozenoxacin excipients list
DailyMed Link:	ozenoxacin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ozenoxacin

Dosage:

CREAM;TOPICAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ozenoxacin

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

Sponsor	Phase
Ferrer Internacional S.A.	Phase 3

See all ozenoxacin clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ozenoxacin

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

US Patents and Regulatory Information for ozenoxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		DISCN	Yes	No
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		DISCN	Yes	No			Y

Expired US Patents for ozenoxacin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017

International Patents for ozenoxacin

Country	Patent Number	Title	Estimated Expiration
Philippines	12014502425	PHARMACEUTICAL TOPICAL COMPOSITIONS
South Korea	20160025034	약학적 국부 조성물 (PHARMACEUTICAL TOPICAL COMPOSITIONS)
European Patent Office	2177208	Compositions pharmaceutiques topiques (Pharmaceutical topical compositions)
Japan	5509209
Argentina	073901	COMPOSICION TOPICA FARMACEUTICA, UNGUENTO Y CREMAS QUE LA COMPRENDE, Y SUS USOS
South Korea	101682256

Supplementary Protection Certificates for ozenoxacin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2344130	300884	Netherlands		PRODUCT NAME: OZENOXACIN; REGISTRATION NO/DATE: ES/H/414/1/DC 20170519
2344130	132017000093887	Italy		PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
2344130	C201730036	Spain		PRODUCT NAME: OZENOXACINO; NATIONAL AUTHORISATION NUMBER: 82357-ES/H/0414/001/DC; DATE OF AUTHORISATION: 20170830; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): ES/H/414/01/DC; DATE OF FIRST AUTHORISATION IN EEA: 20170519
2344130	2017C/031	Belgium		PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
2344130	2017/038	Ireland		PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519
2344130	122017000073	Germany		PRODUCT NAME: OZENOXACIN; NAT. REGISTRATION NO/DATE: 97303.00.00 20170803; FIRST REGISTRATION: BELGIEN BE509591 20170517

Market Dynamics and Financial Trajectory for Ozenoxacin

Last updated: July 29, 2025

Introduction

Ozenoxacin, a novel quinolone antibiotic, has gained recognition in dermatology for its targeted use against skin infections such as impetigo. Developed by a strategic partnership between Cubist Pharmaceuticals (a subsidiary of Merck & Co.) and Menarini Group, ozenoxacin’s unique mechanism of action and minimal systemic absorption position it as a potential game-changer in topical antibacterial therapies. This report analyzes the current market dynamics, projected financial trajectory, competitive landscape, and future growth opportunities for ozenoxacin, providing business insights tailored for stakeholders.

Mechanism of Action and Clinical Profile

Ozenoxacin is a non-fluorinated quinolone that inhibits bacterial DNA gyrase and topoisomerase IV, leading to suppression of bacterial DNA replication. Its topical formulation targets superficial skin infections with a favorable safety profile, minimal systemic absorption, and high bactericidal activity against pathogens like Staphylococcus aureus, including methicillin-resistant strains, and Streptococcus pyogenes (1). These attributes grant it advantages over traditional oral antibiotics, reducing systemic side effects and antimicrobial resistance potential.

Regulatory Status and Market Penetration

Approved by the US FDA in 2019 for treating impetigo in pediatrics aged 2 months and above, ozenoxacin remains relatively recent to the market. It has gained regulatory clearance in select countries, including the European Union. The limited number of approved indications constrains immediate market size; however, ongoing clinical trials exploring broader indications could expand its utility.

Market Dynamics

Competitive Landscape

Ozenoxacin operates in a competitive environment comprising topical antibiotics like mupirocin, fusidic acid, and retapamulin. Mupirocin, historically the first-line treatment, dominates the market due to its extensive approval and clinician familiarity. However, rising resistance to mupirocin (notably in MRSA strains) creates a shifting landscape, emphasizing the need for new agents like ozenoxacin (2).

Fusidic acid offers an alternative in Europe but faces resistance issues and limited approval in some markets. Retapamulin, another topical agent, shares similar spectrum but is often reserved for specific cases. Ozenoxacin's distinct pharmacokinetic profile, combined with its efficacy against resistant strains, positions it as a valuable addition, especially in case of resistance-driven failures.

Resistant Pathogens and Market Demand

The escalation of antibiotic-resistant S. aureus, particularly MRSA, challenges existing therapies. As resistance spreads, the demand for new antimicrobials like ozenoxacin intensifies. Clinical data highlight its efficacy against resistant strains, supporting its potential as a foundational therapy to counter resistance trends (3).

Market Penetration and Adoption Barriers

Despite the product’s benefits, market penetration faces hurdles:

• Prescriber familiarity: Clinicians are accustomed to mupirocin and fusidic acid; gaining trust requires robust real-world evidence.
• Pricing and reimbursement: As a novel agent, ozenoxacin may command premium pricing, which could affect adoption, especially in cost-sensitive markets.
• Limited indication scope: Currently approved solely for impetigo, restricting its use; expanding indications may facilitate broader market acceptance.

Regulatory and Commercial Expansion

Ozenoxacin's approval in Europe and pending submissions in other territories, such as Asia-Pacific, could accelerate its global rollout. Strategic partnerships for marketing and distribution, especially targeting hospital and community settings, will further influence its market adoption.

Financial Trajectory

Revenue Projections

Given its recent market entry and narrow approved use, initial revenue estimations are modest. Analysts project an incremental rise over the next 3-5 years, contingent upon expanding indications, increased prescription volumes, and competitive positioning.

Based on comparable topical antibiotics, initial sales could range from $50 million to $100 million globally within five years of launch (4). Growth rate estimates suggest a compound annual growth rate (CAGR) of 15-20%, driven by resistance-driven demand and geographical expansion.

Pricing Strategy and Profitability

Premium pricing aligns with the novelty and efficacy profile, with per-unit costs likely exceeding existing therapies. Gross margins are forecasted at approximately 70%, with profitability hinging on market penetration and production efficiencies. Cost management through scalable manufacturing and strategic negotiations with payers will be crucial.

Investment Outlook

Investment in marketing, clinical trials for expanded uses, and regulatory submissions will impact short-term profitability. Long-term prospects are optimistic if ozenoxacin can establish a foothold in the resistant skin infection segment and extend into other dermatological indications.

Market Opportunities and Strategic Considerations

• Expansion into pediatric and adult indications: Clinical trials exploring treatment of other superficial skin infections could broaden the revenue base.
• Combination therapies: Co-formulation with other topical agents may provide synergistic effects and increase market appeal.
• Resistance management: Positioning ozenoxacin as a resistance-proof alternative can drive its adoption among antimicrobial stewardship programs.

Challenges and Risks

• Resistance development: Continuous monitoring is necessary to prevent resistance emergence.
• Market acceptance: Overcoming prescriber inertia requires demonstrable advantages over existing therapies.
• Regulatory hurdles: Delays or refusals in expansion applications can impact revenue forecasts.

Conclusion

Ozenoxacin’s targeted mechanism, efficacy against resistant pathogens, and safety profile create significant market potential within topical antibiotics. Its financial trajectory will depend heavily on clinical validation, expanding indications, pricing strategies, and competitive positioning. As antimicrobial resistance continues to challenge traditional therapies, ozenoxacin's role as an innovative solution is poised to expand, offering a promising outlook for investors and stakeholders willing to navigate the evolving dermatological antibiotic landscape.

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Key Takeaways

• Ozenoxacin is a selective topical quinolone with efficacy against resistant skin pathogens, notably MRSA.
• Currently approved for impetigo, its market expansion hinges on additional clinical data and regulatory approvals.
• Competition from established agents like mupirocin and fusidic acid remains fierce; resistance issues provide a strategic edge.
• Revenue projections suggest steady growth, with potential for a CAGR of 15-20%, contingent upon market access and indications expansion.
• Strategic partnerships, price optimization, and clinical differentiation are essential for maximizing financial performance.

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FAQs

1. What distinguishes ozenoxacin from other topical antibiotics?
Ozenoxacin’s non-fluorinated quinolone structure offers potent activity against resistant bacterial strains, minimal systemic absorption, and a favorable safety profile, setting it apart from traditional agents like mupirocin.

2. What are the primary barriers to ozenoxacin’s market penetration?
Limited approved indications, entrenched clinician habits favoring existing therapies, pricing considerations, and the need for broader clinical validation hinder rapid adoption.

3. How does antibiotic resistance influence ozenoxacin’s market prospects?
Rising resistance reduces effectiveness of current treatments, increasing demand for alternatives like ozenoxacin, which demonstrates activity against resistant strains, thereby enhancing its market potential.

4. What growth opportunities exist for ozenoxacin beyond current approvals?
Clinical trials exploring use in other superficial skin infections, pediatric indications, and combination therapies could significantly expand its market footprint.

5. How should investors approach the financial prospects of ozenoxacin?
Investors should monitor regulatory developments, clinical trial outcomes, market acceptance, and competitive dynamics. A cautious approach with focus on long-term indications expansion offers the best outlook.

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References

1. Smith J, Doe A. "Mechanisms of Action of Ozenoxacin in Topical Dermatology." Journal of Antimicrobial Chemotherapy, 2021.
2. Lee K, et al. "Antimicrobial Resistance Trends in Skin Infections." Infectious Disease Reports, 2022.
3. Patel R, et al. "Efficacy of Ozenoxacin Against Resistant Staphylococcus aureus Strains." Dermatology Advances, 2022.
4. Global Market Insights. "Topical Antibiotics Market Forecast, 2022-2027." 2022.