FINAFLOXACIN - Generic Drug Details

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

Finafloxacin is the generic ingredient in one branded drug marketed by Fonseca Biosciences and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Finafloxacin has forty-two patent family members in eighteen countries.

Summary for FINAFLOXACIN

International Patents:	42
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	44
Clinical Trials:	7
Patent Applications:	178
DailyMed Link:	FINAFLOXACIN at DailyMed

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

Constraining patent/regulatory exclusivity:

9,119,859

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.

Recent Clinical Trials for FINAFLOXACIN

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

Sponsor	Phase
MerLion Pharmaceuticals GmbH	Phase 2
MerLion Pharmaceuticals GmbH	Phase 1

See all FINAFLOXACIN clinical trials

US Patents and Regulatory Information for FINAFLOXACIN

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	9,504,691		Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No	9,993,483		Y
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No	8,536,167
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014		DISCN	Yes	No	9,119,859

Expired US Patents for FINAFLOXACIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,133,260
Fonseca Biosciences	XTORO	finafloxacin	SUSPENSION/DROPS;OTIC	206307-001	Dec 17, 2014	6,432,948

International Patents for FINAFLOXACIN

Country	Patent Number	Title	Estimated Expiration
Taiwan	201102395	Compositions and methods for treating ophthalmic, otic, or nasal infections
Mexico	2015007182	COMPOSICIONES EN SUSPENSION DE FINAFLOXACINA. (FINAFLOXACIN SUSPENSION COMPOSITIONS.)
Philippines	12015501230	FINAFLOXACIN SUSPENSION COMPOSITIONS
Canada	2888641	COMPOSITIONS DE SUSPENSION DE FINAFLOXACINE (FINAFLOXACIN SUSPENSION COMPOSITIONS)
China	102470139	Compositions comprising finafloxacin and methods for treating ophthalmic, otic, or nasal infections

FINAFLOXACIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Finafloxacin

Introduction

Finafloxacin, a novel 5th generation fluoroquinolone antibiotic, has been making significant strides in the pharmaceutical market, particularly in the treatment of various bacterial infections. Developed by MerLion Pharmaceuticals, this drug has shown promising results in clinical trials and has garnered significant attention for its efficacy and safety profile.

Market Need and Demand

The increasing prevalence of antibiotic-resistant bacteria has created a critical need for effective and safe antimicrobial agents. Finafloxacin addresses this need by demonstrating broad-spectrum activity against a wide range of bacteria, including multi-drug resistant (MDR) strains and biofilm-forming bacteria[1][3][4].

Regulatory Approvals and Designations

Finafloxacin has received several key regulatory approvals and designations that enhance its market potential. The US FDA has designated the oral and intravenous formulations of finafloxacin as a Qualified Infectious Disease Product (QIDP), which includes fast track development status for complicated urinary tract infections (cUTIs), complicated intraabdominal infections (cIAIs), and acute bacterial skin and skin structure infections (ABSSSIs)[1][3].

Clinical Trials and Efficacy

The drug has completed several clinical trials, including phase II studies for cUTIs, with promising results. Finafloxacin has shown rapid bactericidal activity, even against slow-growing and biofilm-forming bacteria, and it maintains its efficacy in acidic environments, a condition relevant in many infections[1][3].

Safety and Tolerability

Finafloxacin has demonstrated an outstanding safety and tolerability profile in preclinical and clinical studies. The drug has been well-tolerated in doses up to 1 g/day intravenously for 7 days, with mild adverse events such as headache and diarrhea being the most common[1].

Market Performance of Antimicrobial Drugs

The market performance of antimicrobial drugs, including finafloxacin, is influenced by several factors, including development costs, regulatory approvals, and clinical benefit. Studies have shown that antimicrobial drugs, despite having high development and approval costs, tend to have lower capitalized development and approval costs compared to other drug categories. However, their market sales are generally lower than those of oncology drugs[2].

Sales and Revenue Projections

While specific sales figures for finafloxacin are not yet widely available due to its recent approvals and ongoing clinical trials, the drug's unique profile and regulatory designations suggest a strong potential for market success. The average cumulative 9-quarter sales for antimicrobial drugs with high comparative added clinical benefit scores are around $42 million, but finafloxacin's broad-spectrum activity and favorable safety profile could position it for higher sales[2].

Competitive Landscape

Finafloxacin competes in a market dominated by other fluoroquinolones, but its superior activity against MDR bacteria and its efficacy in acidic environments set it apart. The drug's ability to target biofilms and its strong activity against category A and B biothreats further enhance its competitive edge[1][3].

Biodefense Applications

MerLion's efforts to develop finafloxacin for biodefense purposes, supported by the UK Ministry of Defence and the US Defense Threat Reduction Agency, add another layer of market potential. Finafloxacin's strong activity against nearly all bacteria classified as category A or B biothreats makes it a valuable asset in the biodefense sector[1].

Distribution and Marketing

Fonseca Biosciences has secured exclusive US rights to market and distribute Xtoro (finafloxacin otic suspension) for the treatment of acute otitis externa. This partnership is expected to enhance the drug's market reach and accessibility once it receives final FDA approval for distribution in the US[4].

Financial Considerations

The development and approval costs for finafloxacin, while significant, are aligned with industry standards for antimicrobial drugs. The drug's QIDP designation and fast track status provide economic incentives, including extended market exclusivity and priority review, which can significantly impact its financial trajectory[1][2].

Key Takeaways

• Broad-Spectrum Efficacy: Finafloxacin is effective against a wide range of bacteria, including MDR strains and biofilm-forming bacteria.
• Regulatory Approvals: The drug has received QIDP designation and fast track status for several indications.
• Safety Profile: Finafloxacin has shown an outstanding safety and tolerability profile in clinical trials.
• Market Potential: The drug's unique features and regulatory designations position it for strong market performance.
• Biodefense Applications: Finafloxacin has significant potential in the biodefense sector due to its activity against biothreats.

FAQs

What is finafloxacin and how does it work?

Finafloxacin is a 5th generation fluoroquinolone antibiotic that inhibits DNA synthesis by promoting cleavage of bacterial DNA in the DNA-enzyme complexes of DNA gyrase and topoisomerase IV, leading to bacterial death[1].

What are the key indications for finafloxacin?

Finafloxacin is being developed for the treatment of complicated urinary tract infections (cUTIs), complicated intraabdominal infections (cIAIs), acute bacterial skin and skin structure infections (ABSSSIs), and acute otitis externa (AOE)[1][3][4].

What sets finafloxacin apart from other fluoroquinolones?

Finafloxacin's superior activity in acidic environments, its efficacy against MDR bacteria, and its ability to target biofilms distinguish it from other fluoroquinolones[1][3].

Has finafloxacin received any regulatory approvals?

Yes, finafloxacin has been approved by the US FDA as a topical medication (Xtoro) for the treatment of acute otitis externa, and it has received QIDP designation and fast track status for several other indications[1][3][4].

What is the current market status of finafloxacin?

Finafloxacin is in various stages of clinical development for different indications. The otic suspension (Xtoro) is awaiting final FDA approval for distribution in the US, while other formulations are in phase II and III clinical trials[1][3][4].

Sources

1. MerLion Pharmaceuticals. Finafloxacin Overview.
2. ASPE. Antimicrobial Drugs Market Returns Analysis.
3. PubMed. Finafloxacin: first global approval.
4. Biospace. Fonseca Biosciences Secures Exclusive US Rights to XTORO (finafloxacin otic suspension).