BESIFLOXACIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for besifloxacin hydrochloride and what is the scope of patent protection?

Besifloxacin hydrochloride is the generic ingredient in one branded drug marketed by Bausch And Lomb and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Besifloxacin hydrochloride has twenty-four patent family members in thirteen countries.

There are four drug master file entries for besifloxacin hydrochloride. Two suppliers are listed for this compound.

Summary for BESIFLOXACIN HYDROCHLORIDE

International Patents:	24
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	66
Clinical Trials:	17
Patent Applications:	41
DailyMed Link:	BESIFLOXACIN HYDROCHLORIDE at DailyMed

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

Dosage:

SUSPENSION/DROPS;OPHTHALMIC

^*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 BESIFLOXACIN HYDROCHLORIDE

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

Sponsor	Phase
Instituto de Oftalmología Fundación Conde de Valenciana	Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A
McGill University Health Center	N/A

See all BESIFLOXACIN HYDROCHLORIDE clinical trials

Pharmacology for BESIFLOXACIN HYDROCHLORIDE

Drug Class

Quinolone Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for BESIFLOXACIN HYDROCHLORIDE

S01AE	Fluoroquinolones
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BESIFLOXACIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes				Y
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes			Y
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009		RX	Yes	Yes

Expired US Patents for BESIFLOXACIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009
Bausch And Lomb	BESIVANCE	besifloxacin hydrochloride	SUSPENSION/DROPS;OPHTHALMIC	022308-001	May 28, 2009

International Patents for BESIFLOXACIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010111116
Brazil	PI1009849	forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.
Taiwan	I468394
Canada	2756769	CRISTAUX MOLECULAIRES D'ACIDE FLUOROQUINOLONE-CARBOXYLIQUE (FLUOROQUINOLONE CARBOXYLIC ACID MOLECULAR CRYSTALS)
Mexico	2009009657	FLUOROQUINOLONAS PARA EL TRATAMIENTO, REDUCCION, MEJORA, O PREVENCION DE LAS INFECCIONES PROVOCADAS POR LAS BACTERIAS RESISTENTES A LOS FARMACOS ANTIBACTERIANOS. (FLUOROQUINOLONES FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA.)
World Intellectual Property Organization (WIPO)	2010051291
European Patent Office	2136812	FLUOROQUINOLONES POUR TRAITER, RÉDUIRE, AMÉLIORER OU PRÉVENIR DES INFECTIONS CAUSÉES PAR DES BACTÉRIES RÉSISTANTES AUX MÉDICAMENTS ANTIBACTÉRIENS (COMPOSITIONS AND METHODS FOR TREATING, REDUCING, AMELIORATING, OR PREVENTING INFECTIONS CAUSED BY ANTIBACTERIAL DRUG-RESISTANT BACTERIA)

BESIFLOXACIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Besifloxacin Hydrochloride

Introduction

Besifloxacin hydrochloride, marketed under the trade name Besivance™, is a fluoroquinolone antibiotic exclusively developed for topical ophthalmic use. It has gained significant attention for its efficacy in treating bacterial conjunctivitis, a common ocular infection. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Players and Competition

The besifloxacin API market is characterized by several key players, including Neuland Laboratories, Hec Pharma, Indoco, LGM Pharma, and others. These companies play a crucial role in the production and distribution of besifloxacin, influencing the market's competitive landscape[1].

Clinical Efficacy and Demand

Besifloxacin has demonstrated high clinical efficacy in treating bacterial conjunctivitis, outperforming vehicle controls and showing comparable results to other fluoroquinolones like moxifloxacin. Its broad-spectrum activity against common ocular pathogens, including drug-resistant strains, contributes to its demand in the market[2][4].

Regulatory Approvals

Besifloxacin hydrochloride was approved by the FDA in May 2009 for the treatment of bacterial conjunctivitis in adults and children over one year of age. Subsequent approvals in other regions, such as Brazil in 2011, have expanded its market reach[4].

Pharmacokinetics and Safety

The drug's low systemic exposure, which is a result of its topical application, minimizes the risk of systemic side effects and drug-drug interactions. This profile enhances its safety and contributes to its market acceptance. Studies have shown that besifloxacin has very low plasma concentrations, with a maximum plasma concentration of less than 1.3 ng/mL, indicating minimal systemic absorption[3].

Dosage and Treatment Regimen

The recommended dosage for besifloxacin hydrochloride is one drop in the affected eye three times a day for 5 days, which may be extended to 7 days based on medical criteria. This regimen has been validated through clinical studies, ensuring a consistent and effective treatment protocol[4].

Market Growth and Projections

The global market for besifloxacin API is expected to grow, driven by the increasing incidence of bacterial conjunctivitis and the need for effective, resistance-sparing antibiotics. The market's growth is also influenced by advancements in nanotechnology, which could enhance the bioavailability and safety of besifloxacin nanocrystals[5].

Financial Trajectory

Revenue and Sales

The financial performance of besifloxacin hydrochloride is closely tied to its clinical efficacy and market demand. With FDA approval and subsequent approvals in other regions, the drug has seen significant revenue growth. Bausch & Lomb, the primary marketer of Besivance™, has benefited from the drug's strong market position.

Cost and Pricing

The cost of besifloxacin hydrochloride is influenced by production costs, regulatory approvals, and market competition. Given its exclusive use for ophthalmic infections, the pricing strategy is tailored to balance profitability with patient accessibility.

Research and Development

Continuous research and development, particularly in the area of nanotechnology, are expected to further enhance the drug's performance and market appeal. Investments in these areas are likely to impact the financial trajectory positively, as they could lead to improved formulations and expanded applications[5].

Challenges and Opportunities

Bacterial Resistance

One of the significant challenges in the antibiotic market is the rise of bacterial resistance. However, besifloxacin's unique mechanism of action and low systemic exposure reduce the risk of resistance development, making it a valuable asset in the market[4].

Regulatory Environment

Navigating regulatory environments in different regions can be challenging. However, besifloxacin's approval in key markets has paved the way for its global expansion.

Technological Advancements

Advancements in nanotechnology offer opportunities for improving the drug's bioavailability and safety. The development of besifloxacin nanocrystals, for instance, could enhance its dissolution rate and overall efficacy[5].

Key Takeaways

• Clinical Efficacy: Besifloxacin hydrochloride has proven efficacy in treating bacterial conjunctivitis, outperforming some competitors.
• Market Players: Multiple companies are involved in the production and distribution of besifloxacin API.
• Regulatory Approvals: FDA and other regional approvals have expanded its market reach.
• Pharmacokinetics: Low systemic exposure enhances safety and minimizes drug-drug interactions.
• Financial Growth: The market is expected to grow driven by increasing demand and technological advancements.

FAQs

What is besifloxacin hydrochloride used for?

Besifloxacin hydrochloride is used exclusively for the treatment of bacterial conjunctivitis.

Who are the main players in the besifloxacin API market?

The main players include Neuland Laboratories, Hec Pharma, Indoco, LGM Pharma, and others[1].

What is the recommended dosage for besifloxacin hydrochloride?

The recommended dosage is one drop in the affected eye three times a day for 5 days, which may be extended to 7 days based on medical criteria[4].

How does besifloxacin hydrochloride compare to other fluoroquinolones?

Besifloxacin has shown comparable efficacy to other fluoroquinolones like moxifloxacin and has a lower risk of developing resistance due to its reduced systemic exposure[2][4].

What are the potential future developments for besifloxacin hydrochloride?

Advancements in nanotechnology, such as the development of besifloxacin nanocrystals, could enhance its bioavailability and safety[5].

Sources

1. Global Besifloxacin API Market Insights, Forecast to 2029 - Valuates Reports
2. Besifloxacin ophthalmic suspension: Topics by Science.gov - Science.gov
3. auspar-besifloxacin-hydrochloride-140203-cer.pdf - TGA Australia
4. Besifloxacin: A Critical Review of Its Characteristics, Properties, and Analytical Methods - UNESP
5. Besifloxacin Nanocrystal: Towards an Innovative Ophthalmic Formulation - NCBI