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:	53
Clinical Trials:	2
Patent Applications:	136
What excipients (inactive ingredients) are in ozenoxacin?	ozenoxacin excipients list
DailyMed Link:	ozenoxacin at DailyMed

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

Constraining patent/regulatory exclusivity:

9,180,200

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	9,399,014
Ferrer Internacional	XEPI	ozenoxacin	CREAM;TOPICAL	208945-001	Dec 11, 2017		DISCN	Yes	No	9,180,200		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	6,335,447

International Patents for ozenoxacin

Country	Patent Number	Title	Estimated Expiration
Cyprus	1114838
Brazil	PI0920355	composições farmacêuticas tópicas estáveis de ozenoxacina e uso de ozenoxacina
European Patent Office	2570117	Compositions pharmaceutiques topiques (Pharmaceutical topical compositions)
China	102186460	Pharmaceutical topical compositions
Taiwan	201511779	Pharmaceutical topical compositions comprising ozenoxacin and uses of the same
Japan	5509209
European Patent Office	2344130	COMPOSITIONS PHARMACEUTIQUES TOPIQUES (PHARMACEUTICAL TOPICAL COMPOSITIONS)

Supplementary Protection Certificates for ozenoxacin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2344130	1790031-7	Sweden		PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519
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	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	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

Ozenoxacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ozenoxacin

Introduction

Ozenoxacin is a topical quinolone antibiotic that has garnered significant attention in the dermatology sector, particularly for its efficacy in treating acne, impetigo, and other skin infections. Here, we delve into the market dynamics and financial trajectory of ozenoxacin, highlighting its key milestones, market performance, and future projections.

Mechanism and Therapeutic Areas

Ozenoxacin works by inhibiting bacterial DNA gyrase and topoisomerase IV, making it a potent antibacterial agent against pathogens such as Cutibacterium acnes (C. acnes), which is commonly associated with acne[1].

Regulatory Approvals and Launches

Ozenoxacin has received regulatory approvals in several countries. Notably, it was first approved in Japan on September 11, 2015, for the treatment of acne vulgaris, impetigo, and complicated skin and soft tissue infections[1]. In Canada, Cipher Pharmaceuticals acquired the Canadian rights to ozenoxacin and had it accepted for review by Health Canada with a target approval date in Q2 2017[2].

Market Performance

Revenue Growth

The introduction of ozenoxacin into the market has contributed to the revenue growth of companies like Cipher Pharmaceuticals. In 2016, Cipher reported a significant increase in product revenue, with ozenoxacin being one of the key products in their pipeline. The company's U.S. business saw an 80% increase in product revenue compared to Q2 2015, and their Canadian business experienced a 51% growth in product revenue in local currency[2].

Market Share and Competitiveness

Ozenoxacin's unique application regimen, requiring only twice-daily application for five days, sets it apart from competitors that often require three times daily application for 7 to 10 days[5]. This convenience factor has helped ozenoxacin gain a competitive edge in the market.

Financial Trajectory

Revenue Projections

The global ozenoxacin market is projected to grow significantly, with the market size valued at approximately $150 million in 2023 and expected to reach around $300 million by 2032[4].

Company-Specific Financials

Cipher Pharmaceuticals, a key player in the commercialization of ozenoxacin, has seen substantial financial growth. In 2018, the company's Canadian business reported a 30% increase in product revenue, driven in part by the performance of ozenoxacin and other dermatology products[3].

Transactions and Acquisitions

The financial trajectory of ozenoxacin is also influenced by strategic transactions. Cipher Pharmaceuticals acquired the Canadian rights to ozenoxacin from Ferrer of Spain, which included an upfront payment and potential milestone payments upon regulatory approval and commercialization[5].

Clinical Trials and Safety Profile

Phase 3 Trials

Ozenoxacin has undergone extensive Phase 3 clinical trials, which have shown positive results. For instance, a Phase 3 study involving 411 patients reported that only 1 out of 8 patients experiencing adverse effects had an effect potentially related to the study treatment, and none were serious[1].

Safety and Efficacy

The safety and efficacy profile of ozenoxacin has been favorable, with minimal serious adverse effects reported in clinical trials. This profile has been crucial in gaining regulatory approvals and market acceptance.

Market Expansion and Future Prospects

Geographic Expansion

Ozenoxacin's market is expected to expand beyond its current geographic reach. With approvals in Japan and Canada, and ongoing reviews in other regions, the drug is poised to enter new markets, further boosting its revenue potential.

Competitive Landscape

The dermatology market is highly competitive, but ozenoxacin's unique features and strong clinical data position it well against other topical antibiotics. As the market grows, ozenoxacin is likely to remain a significant player.

Key Takeaways

• Regulatory Approvals: Ozenoxacin has received approvals in Japan and Canada, with ongoing reviews in other regions.
• Market Performance: The drug has contributed to significant revenue growth for companies like Cipher Pharmaceuticals.
• Financial Projections: The global ozenoxacin market is expected to reach $300 million by 2032.
• Clinical Trials: Phase 3 trials have shown a favorable safety and efficacy profile.
• Market Expansion: Ozenoxacin is poised to enter new markets, further expanding its revenue potential.

FAQs

Q: What is ozenoxacin used for?

Ozenoxacin is used to treat acne, impetigo, and complicated skin and soft tissue infections.

Q: Who are the key players in the commercialization of ozenoxacin?

Cipher Pharmaceuticals is a key player in the commercialization of ozenoxacin, particularly in Canada.

Q: What is the projected market size of ozenoxacin by 2032?

The global ozenoxacin market is projected to reach around $300 million by 2032[4].

Q: How does ozenoxacin differ from other topical antibiotics?

Ozenoxacin requires only twice-daily application for five days, setting it apart from competitors that often require more frequent and longer treatment regimens[5].

Q: What are the safety and efficacy profiles of ozenoxacin?

Ozenoxacin has a favorable safety and efficacy profile, with minimal serious adverse effects reported in clinical trials[1].

Sources

1. Patsnap Synapse: Ozenoxacin - Drug Targets, Indications, Patents.
2. Cipher Pharmaceuticals: Building a Dermatology Growth Company - Cipher Pharmaceuticals.
3. Cipher Pharmaceuticals: Annual Reports.
4. Dataintelo: Global Ozenoxacin Market Research Report 2032.
5. Small-Cap Research: Cipher Pharmaceutical (CPHR) Q1 2015 Report.