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 Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BESIFLOXACIN HYDROCHLORIDE
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
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

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
South Korea	20130010131
European Patent Office	2136812
Spain	2427596
Mexico	2009009657
Japan	2012521433

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Besifloxacin Hydrochloride

Last updated: July 27, 2025

---

Introduction

Besifloxacin hydrochloride, a broad-spectrum fluoroquinolone antibiotic, has gained prominence within ophthalmology for its efficacy against bacterial conjunctivitis. Since its FDA approval in 2010, it has been positioned as a strategic option for antimicrobial therapy, partly driven by rising antibiotic resistance. This analysis explores the complex market dynamics shaping besifloxacin hydrochloride’s trajectory, considering factors such as competitive landscape, regulatory environment, clinical demand, manufacturing economics, and broader healthcare trends.

---

Market Overview

Therapeutic Indication and Sales Drivers

Primarily prescribed for bacterial conjunctivitis, besifloxacin hydrochloride benefits from a high-prevalence niche within ophthalmic drug markets. The global incidence of conjunctivitis, especially bacterial types, ranges widely but remains a persistent infection across diverse demographics. The rise of antibiotic resistance has heightened the clinical attractiveness of newer agents like besifloxacin, which exhibit enhanced efficacy and reduced resistance potential ([1]).

Market Penetration and Adoption

Despite being a relatively recent entrant, besifloxacin has gained substantial market share in North America and parts of Europe, driven by ophthalmologists' preference for its broad-spectrum coverage and favorable safety profile. The drug’s unique formulation as a suspension eye drop aids compliance, further reinforcing market adoption. However, its growth trajectory is constrained by existing entrenched competitors and pricing considerations.

---

Competitive Landscape

Major Competitors

Besifloxacin faces competition from established fluoroquinolones such as ciprofloxacin, levofloxacin, and moxifloxacin, which have longstanding prescriber familiarity and extensive clinical data. Alternative formulation options, including combination antibiotics, also vie for market share. Notably, agents like ofloxacin and other newer fluoroquinolones benefit from broader indications beyond ophthalmology, affecting captive market potential for besifloxacin.

Differentiation Factors

Becton Dickinson and Alcon, the primary commercial entities marketing besifloxacin, leverage its targeted ophthalmic formulation, resistance profile, and safety data to sustain its market position. The drug's safety profile, with low incidences of side effects and minimal systemic absorption, remains an essential differentiator.

Patent and Regulatory Considerations

From a patent perspective, most exclusivity periods have begun to lapse, potentially exposing the drug to generic competition posts-expiry. The recent approvals of generics could significantly influence pricing and overall revenue streams.

---

Regulatory and Reimbursement Environment

Regulatory Landscape

Regulatory agencies worldwide, including the FDA and EMA, continue to evaluate antibiotics for efficacy and safety amid the global antimicrobial resistance crisis. Reimbursement policies favor innovative drugs with proven clinical benefits, yet price pressures persist. The U.S. policies encouraging judicious antibiotic use may influence prescribing behaviors over time.

Pricing and Insurance Dynamics

Pricing strategies for besifloxacin have historically been premium, justified by clinical benefits and manufacturing complexities. However, increasing competition and the entry of generics threaten profit margins. Insurers may favor more cost-effective alternatives unless besifloxacin demonstrates clear superiority in outcomes.

---

Market Challenges and Opportunities

Challenges

• Generic Competition: As patents expire, the entry of cheaper generics will pressure prices and margins.
• Pricing Pressure: Evidence-based clinical advantages must justify premium positioning.
• Limited Indications: Currently confined largely to bacterial conjunctivitis, restricting revenue diversification.
• Antibiotic Stewardship: Growing emphasis on antimicrobial stewardship may reduce overall antibiotic prescribing, impacting sales.

Opportunities

• Expanded Indications: Potential approvals for deeper bacterial eye infections could broaden addressable markets.
• Geographic Expansion: Penetration into emerging markets, with rising ophthalmic disease prevalence, could augment growth.
• Combination Formulations: Developing combination therapies with other ophthalmic agents could provide therapeutic advantages.
• Resistance Monitoring: Ongoing surveillance indicating lower resistance development may position besifloxacin as a preferred agent.

---

Financial Trajectory

Revenue Forecasts

Estimations suggest that in developed markets, the drug’s revenues will plateau in the mid-term, primarily due to patent expiries and competition. However, strategic expansion into emerging markets and new indications may offset some declines, potentially sustaining a compound annual growth rate (CAGR) of 3-5% over the next five years.

Cost Structure and Profitability

Manufacturing costs for besifloxacin are influenced by complex synthesis steps and formulation delivery. Despite premium pricing, rising generic competition could compress margins, prompting manufacturers to optimize supply chains and seek cost efficiencies.

Investment and R&D Trends

Bio-pharmaceutical companies are likely to focus R&D efforts on novel formulations, delivery systems, and combination therapies that leverage besifloxacin's core advantages. These innovations aim to prolong exclusivity periods and create new revenue streams.

---

Market Trends Impacting Future Outlook

• Antimicrobial Resistance: This global concern elevates the importance of effective topical antibiotics, potentially favoring besifloxacin if resistance remains low.
• Patient Compliance and Safety: Enhanced formulations can improve adherence and safety profiles, critical for long-term market sustainability.
• Digital Health Integration: Use of telemedicine and digital health platforms may influence prescribing patterns and patient engagement in ophthalmic care.
• Healthcare Policy: Policy initiatives promoting antibiotic stewardship could alter prescribing practices, favoring agents with demonstrable benefits.

---

Conclusion

The market dynamics surrounding besifloxacin hydrochloride are characterized by a delicate balance of clinical advantages, competitive pressures, patent landscape shifts, and evolving healthcare policies. While near-term revenues face pressure from generic entries, strategic expansion, formulation innovations, and targeted clinical positioning could sustain its financial trajectory. The key to maximization lies in differentiating from older competitors via improved formulations, expanded indications, and geographic diversification.

---

Key Takeaways

• Market Position: Besifloxacin's unique ophthalmic formulation and resistance profile position it favorably within bacterial conjunctivitis treatments, but face intense competition from established fluoroquinolones.
• Patent Expiry Impact: Upcoming generic entries are expected to reduce pricing power and overall revenues unless new indications or formulations are developed.
• Growth Strategies: Expanding into emerging markets, developing combination therapies, and gaining approvals for broader indications are critical to future growth.
• Regulatory Environment: Strong focus on antimicrobial stewardship may influence prescribing behaviors; therefore, demonstrating superior clinical benefits is essential.
• Financial Outlook: While mid-term growth may slow due to patent expiries, innovation and market expansion could sustain a modest but steady revenue trajectory.

---

FAQs

1. What are the primary clinical advantages of besifloxacin hydrochloride over other ophthalmic antibiotics?
Besifloxacin exhibits broad-spectrum activity against Gram-positive and Gram-negative bacteria with a lower resistance development potential, and it’s formulated for enhanced ocular retention, improving efficacy and patient compliance.

2. How will patent expirations affect the market for besifloxacin?
Patent expirations are likely to invite generic competition, intensifying price erosion and reducing profit margins unless the company introduces new formulations or expands indications.

3. Are there potential new markets or indications for besifloxacin?
Yes. Potential expansion into deeper ocular infections and other bacterial indications could diversify revenue streams. Additionally, emerging markets with rising ophthalmic disease burdens represent growth opportunities.

4. How does antimicrobial stewardship influence the future of besifloxacin sales?
Stewardship initiatives aim to reduce unnecessary antibiotic use, which could restrain sales volume. Demonstrating clinical superiority and efficacy could, however, justify continued or increased prescribing.

5. What strategies can manufacturers adopt to maximize the drug’s market longevity?
Investments in research for new formulations/formulations, entry into untapped geographic markets, development of combination therapies, and aggressive clinical positioning are vital strategies.

---

References

[1] Smith, J. et al. (2022). "Emerging Trends in Ophthalmic Antibiotics." Journal of Ophthalmology Advances, 15(3), 210-225.
(Note: References are illustrative; real citations should be sourced accordingly.)