XTORO Drug Patent Profile

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

Xtoro is a drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this drug.

This drug has forty-two patent family members in eighteen countries.

The generic ingredient in XTORO is finafloxacin. Additional details are available on the finafloxacin profile page.

DrugPatentWatch^® Generic Entry Outlook for Xtoro

Xtoro was eligible for patent challenges on December 17, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 2, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for XTORO

International Patents:	42
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	44
Patent Applications:	73
DailyMed Link:	XTORO at DailyMed

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

NDA:

206307

Dosage:

SUSPENSION/DROPS;OTIC

^*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 XTORO

XTORO is protected by four US patents.

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
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No			Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No			Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No

Expired US Patents for XTORO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014

International Patents for XTORO

When does loss-of-exclusivity occur for XTORO?

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

Argentina

Australia

Brazil

Canada

Chile

China

European Patent Office

Japan

Mexico

Russian Federation

South Africa

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 XTORO around the world.

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1025517
China	109908081	非那沙星混悬液组合物 (Finafloxacin suspension compositions)
Bulgaria	64615
Russian Federation	2570731	КОМПОЗИЦИИ, ВКЛЮЧАЮЩИЕ ФИНАФЛОКСАЦИИ, И СПОСОБЫ ЛЕЧЕНИЯ ОФТАЛЬМОЛОГИЧЕСКИХ, УШНЫХ ИЛИ НАЗАЛЬНЫХ ИНФЕКЦИЙ (FINAFLOXACIN-INCLUDING COMPOSITIONS, AND METHODS OF TREATING OPHTHALMOLOGICAL, AURAL AND NASAL INFECTIONS)
New Zealand	336228	The use of 8-cyano-1-cyclopropyl-6-fluoro-7-((1S,6S)-2-oxa-5,8-diazabicyclo[4.3.0]non-8-yl-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid for the treatment of helicobacter pylori infections and associated gastroduodenal diseases
China	1245428

XTORO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: XTORO

Introduction

XTORO, an otic suspension containing the antibiotic finafloxacin, has been a significant development in the treatment of acute otitis externa (AOE), commonly known as swimmer's ear. This article delves into the market dynamics and financial trajectory of XTORO, highlighting its development, approval, market launch, and the financial implications for its manufacturer, MerLion Pharmaceuticals.

Development and Approval of XTORO

XTORO is a novel fluoroquinolone antibiotic developed by MerLion Pharmaceuticals. It has been approved by the US FDA and Health Canada for the treatment of AOE, with or without an otowick[1][5].

Clinical Trials

The efficacy of XTORO was established through two randomized, multicenter, vehicle-controlled clinical trials. These trials demonstrated that XTORO was superior to its vehicle in both clinical and microbiological outcomes, as well as in reducing the time to cessation of ear pain in patients with AOE. The clinical cure rate on Day 11 was 71% for XTORO compared to 37% for the vehicle group[5].

Market Launch and Financing

Growth Financing Round

To facilitate the production and market launch of XTORO, MerLion Pharmaceuticals completed a growth financing round in 2021. This round was raised through a private placement to European strategic investors, including existing investors like HeidelbergCapital and Vl Partners, and new investors such as Denk Pharma GmbH & Co. KG[1].

Investor Confidence

The successful financing round reflects the high potential of XTORO and the confidence of investors in MerLion's strategy. Dr. Andreas Vente, Managing Director of MerLion, emphasized that this financing is a significant milestone in the company's mission to launch XTORO in the US and Canada[1].

Market Dynamics

Competitive Landscape

The antibiotic market, particularly for treatments of bacterial infections, is highly competitive. However, XTORO stands out due to its unique mode of action, which allows it to remain effective in both physiological pH conditions and the acidic environments found at most bacterial infection sites. This distinguishes it from other antibiotics, including other fluoroquinolones, which often show reduced efficacy under acidic conditions[1].

Patient Need and Market Demand

Acute otitis externa is a common condition that affects a wide range of patients, from children to adults. The superior efficacy and fast-acting properties of XTORO are expected to meet a significant patient need, thereby driving market demand. Stephan Huber, Managing Director at Denk Pharma, highlighted that XTORO's properties will considerably aid patients in their recovery[1].

Financial Trajectory

Development Costs

The development of new drugs, including antibiotics like XTORO, is a costly and time-consuming process. The estimated cost of developing a new drug from discovery to approval can range from $1 to $2 billion and spans over 10-15 years[3].

Capitalized Development and Approval Costs

For antimicrobial drugs like XTORO, the average capitalized development and approval costs are relatively lower compared to other drug categories. Studies indicate that antimicrobial drugs have average to high development and approval costs, but when accounting for the cost of failures and opportunity cost of capital, they are the least costly to develop and obtain regulatory approval for, with an average cost of $1,508 million[4].

Market Performance

The market performance of XTORO is expected to be strong due to its high comparative added clinical benefit. Drugs with higher overall comparative added clinical benefit scores tend to have higher early market sales. While the sales figures for XTORO are not yet fully reported, the general trend suggests that antimicrobial drugs with significant clinical benefits can achieve substantial sales, although typically lower than those of oncology drugs[4].

Revenue Projections and Sales

Early Market Sales

The early market sales of XTORO are anticipated to be robust given its superior clinical outcomes. However, the exact revenue projections are not publicly disclosed. Generally, antimicrobial drugs achieve average cumulative sales of around $42 million in the first nine quarters after launch, although this can vary based on several factors including market competition and patient adoption[4].

Long-Term Revenue Potential

The long-term revenue potential for XTORO is significant, given its approval for a common condition like AOE and its unique therapeutic profile. As the drug gains market traction and becomes a preferred treatment option, MerLion Pharmaceuticals can expect sustained revenue growth.

Regulatory and Market Environment

FDA Approval and Compliance

XTORO's approval by the US FDA and Health Canada underscores its compliance with stringent regulatory standards. This approval not only validates the drug's efficacy and safety but also opens up significant market opportunities in North America[1][5].

Global Expansion

While the initial focus is on the US and Canadian markets, MerLion Pharmaceuticals may explore global expansion opportunities for XTORO. This could involve additional regulatory approvals and partnerships with local distributors, further expanding the drug's market reach.

Conclusion

The market dynamics and financial trajectory for XTORO are promising, driven by its unique therapeutic profile, strong clinical outcomes, and significant patient need. The successful growth financing round and investor confidence in MerLion Pharmaceuticals indicate a positive outlook for the drug's market launch and future revenue potential.

Key Takeaways

• Unique Therapeutic Profile: XTORO's effectiveness in both physiological and acidic environments sets it apart from other antibiotics.
• Strong Clinical Outcomes: Clinical trials have shown XTORO to be superior in treating acute otitis externa.
• Significant Patient Need: The drug addresses a common condition affecting a wide range of patients.
• Investor Confidence: The growth financing round reflects high investor confidence in XTORO and MerLion's strategy.
• Regulatory Approval: FDA and Health Canada approvals validate the drug's efficacy and safety.
• Market Performance: Expected strong early market sales and long-term revenue potential.

FAQs

What is XTORO used for?

XTORO is used to treat acute otitis externa (AOE), also known as swimmer's ear, with or without an otowick[5].

Who developed XTORO?

XTORO was developed by MerLion Pharmaceuticals GmbH, a biopharmaceutical company headquartered in Berlin, Germany[1].

What makes XTORO unique?

XTORO remains effective in both physiological pH conditions and the acidic environments found at most bacterial infection sites, distinguishing it from other antibiotics[1].

How much did the development of XTORO cost?

The exact development cost of XTORO is not disclosed, but the average cost for developing an antimicrobial drug is around $1,508 million when accounting for failures and opportunity costs[4].

What are the market prospects for XTORO?

The market prospects for XTORO are strong due to its high comparative added clinical benefit, significant patient need, and positive clinical outcomes. Early market sales are expected to be robust, with long-term revenue potential driven by its unique therapeutic profile and regulatory approvals[1][4].

Sources

1. MerLion Pharmaceuticals Completes Growth Financing Round - MerLion Pharmaceuticals.
2. Novartis 20-F 2014 - Novartis.
3. Analysis of FDA Novel Drug Approvals - Biomed Pharma Journal.
4. Antimicrobial Drugs Market Returns Analysis - ASPE.
5. Xtoro (Finafloxacin Otic Suspension): Side Effects, Uses ... - RxList.