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XEPI Drug Patent Profile

When do Xepi patents expire, and what generic alternatives are available?

Xepi is a drug marketed by Ferrer Internacional and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in XEPI is ozenoxacin. There is one drug master file entry for this compound. Additional details are available on the ozenoxacin profile page.

DrugPatentWatch^® Generic Entry Outlook for Xepi

Xepi was eligible for patent challenges on December 11, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 29, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XEPI

International Patents:	37
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	53
Patent Applications:	58
What excipients (inactive ingredients) are in XEPI?	XEPI excipients list
DailyMed Link:	XEPI at DailyMed

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

Constraining patent/regulatory exclusivity:

9,180,200

NDA:

208945

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.

US Patents and Regulatory Information for XEPI

XEPI is protected by two US patents.

This potential generic entry date is based on patent 9,180,200.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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 XEPI

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 XEPI

When does loss-of-exclusivity occur for XEPI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Cyprus

Denmark

European Patent Office

Hong Kong

Japan

Mexico

Netherlands

Philippines

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XEPI around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1039484
Spain	2273479
Canada	2327328	DERIVES D'ACIDE QUINOLONECARBOXYLIQUE OU SELS DE CEUX-CI (QUINOLONECARBOXYLIC ACID DERIVATIVES OR SALTS THEREOF)
Japan	2012505867
Taiwan	201018497	Pharmaceutical topical compositions

Supplementary Protection Certificates for XEPI

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

XEPI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: XEPI

Introduction

XEPI, a non-fluorinated topical quinolone, has been a significant addition to the treatment arsenal for impetigo, a highly contagious bacterial skin infection. Here, we delve into the market dynamics and financial trajectory of XEPI, highlighting its launch, market impact, and financial performance.

Launch and Approval

XEPI was launched in 2018 by Cutanea Life Sciences, which was later acquired by Biofrontera AG. The drug received approval from the Food and Drug Administration (FDA) for the treatment of impetigo due to certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients 2 months of age and older[4].

Market Impact

Clinical Success and Efficacy

Clinical trials demonstrated the efficacy of XEPI, with clinical success rates significantly higher than those of the placebo groups. In two trials, XEPI showed clinical success rates of 34.8% and 54.4%, compared to 19.2% and 37.9% for the placebo groups, respectively[4].

Market Positioning

Despite being a relatively new entrant, XEPI has quickly gained traction in the market. Biofrontera successfully placed XEPI on the reimbursement lists of major U.S. insurance companies, making it accessible to about half of the U.S. population. This strategic move was crucial in expanding its market reach and acceptance[3].

Financial Performance

Revenue Growth

The acquisition of Cutanea Life Sciences and the subsequent launch of XEPI contributed to Biofrontera's revenue growth. In 2019, Biofrontera reported a sales growth of around 48% compared to the previous year, with significant contributions from the U.S. market. The fourth quarter of 2019 was particularly strong, marking the highest quarterly sales in the company's history[3].

Market Expansion

The inclusion of XEPI in Biofrontera's product portfolio has been instrumental in expanding the company's market share. The drug's performance has been a key factor in Biofrontera's ability to navigate through challenging times, including the COVID-19 pandemic. The company's strategic focus on XEPI, along with other products like Ameluz®, has helped maintain a strong financial position[2].

Market Trends and Drivers

Rise in Infectious Diseases

The rise in outbreaks of infectious diseases, including impetigo, has driven the demand for effective treatments. XEPI has benefited from this trend, as it offers a topical, non-fluorinated alternative that is both effective and convenient[1].

Healthcare Expenditure

Increased healthcare expenditure and the adoption of new treatments have also fueled the growth of the impetigo treatment market. XEPI's approval and inclusion in insurance reimbursement lists have made it a viable option for patients, contributing to its market success[1].

R&D Activities

Continuous research and development activities aimed at improving the quality of drugs for treating impetigo have created opportunities for XEPI. Biofrontera's focus on R&D, including collaborations with major shareholders like Maruho, has helped in expanding the product pipeline and enhancing market competitiveness[3].

Challenges and Restraints

Side Effects and Generic Alternatives

Despite its market success, XEPI faces challenges such as side effects associated with its use and the presence of alternative generic medications. These factors can restrain the growth of the drug in the market[1].

Market Competition

The dermatology market is highly competitive, with several established players. XEPI must compete with other treatments, including broad-spectrum antibiotics and other topical creams, to maintain its market share[1].

Government Initiatives and Emerging Markets

Regulatory Approvals

Government initiatives for fast-track regulatory approvals for novel drugs have provided lucrative opportunities for XEPI. The FDA approval of XEPI and similar initiatives in other regions have facilitated its entry into new markets[1].

Emerging Markets

The potential for growth in emerging markets is significant. Biofrontera's licensing agreements, such as the one with Maruho Co., Ltd., have opened up new avenues for XEPI in regions beyond Europe and the USA[2].

Key Takeaways

• Launch and Approval: XEPI was launched in 2018 and approved by the FDA for treating impetigo.
• Market Impact: The drug has shown significant clinical success and has been included in major U.S. insurance reimbursement lists.
• Financial Performance: XEPI has contributed to Biofrontera's revenue growth, particularly in the U.S. market.
• Market Trends: The rise in infectious diseases and increased healthcare expenditure have driven demand for XEPI.
• Challenges: Side effects and generic alternatives are key restraints.
• Government Initiatives: Fast-track regulatory approvals and emerging market opportunities are crucial for XEPI's growth.

FAQs

What is XEPI used for?

XEPI is a non-fluorinated topical quinolone used for the treatment of impetigo due to certain bacteria (Staphylococcus aureus or Streptococcus pyogenes) in patients 2 months of age and older[4].

Who launched XEPI?

XEPI was launched by Cutanea Life Sciences, which was later acquired by Biofrontera AG[1][3].

How has XEPI performed in clinical trials?

Clinical trials have shown that XEPI has higher clinical success rates compared to placebo groups, with success rates of 34.8% and 54.4% in two trials[4].

What are the key drivers for the growth of XEPI in the market?

Key drivers include the rise in outbreaks of infectious diseases, increased healthcare expenditure, and the inclusion of XEPI in insurance reimbursement lists[1].

What challenges does XEPI face in the market?

XEPI faces challenges such as side effects associated with its use and the presence of alternative generic medications[1].

How has Biofrontera's financial performance been impacted by XEPI?

XEPI has contributed significantly to Biofrontera's revenue growth, particularly in the U.S. market, helping the company achieve its highest quarterly sales in 2019[3].

Sources

1. Allied Market Research: Impetigo Treatment Market Size, Trend And Industry Report 2030
2. Biofrontera AG: Annual Report 2020
3. Biofrontera AG: Annual Report 2019
4. FDA: Drug Trial Snapshot: Xepi