Besifloxacin hydrochloride - Generic Drug Details

What are the generic 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				Y
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

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
China	101641100
Brazil	PI0808823
Taiwan	I468394
Brazil	PI1009849	forma cristalina molecular, uso da forma molecular, e, método para preparar um crsital molecular.
South Korea	20130010131
Hong Kong	1137947
Taiwan	201038536	Fluoroquinolone carboxylic acid molecular crystals

Market Dynamics and Financial Trajectory for Besifloxacin Hydrochloride

Last updated: February 20, 2026

What is the current market landscape for Besifloxacin Hydrochloride?

Besifloxacin Hydrochloride is a broad-spectrum fluoroquinolone antibiotic primarily prescribed for bacterial conjunctivitis. Market competition centers on other ophthalmic antibiotics, including ofloxacin and moxifloxacin. In 2022, the global ophthalmic antibiotics market was valued at approximately $3.2 billion and projected to grow at a compound annual growth rate (CAGR) of around 4.5% through 2030.

How does the competitive environment influence market penetration?

Several manufacturers hold FDA approval for products containing besifloxacin, including Bausch + Lomb, which markets the branded drug, Besivance. Market penetration depends heavily on product differentiation, prescriber preferences, and regulatory exclusivity periods.

Key competitors include:

• Ofloxacin: Established, generic, lower cost.
• Moxifloxacin: Broader spectrum, more established.
• Gatifloxacin and Ciprofloxacin: Also prevalent options.

The uniqueness of besifloxacin lies in its formulation targeting bacterial conjunctivitis with a lower resistance profile. However, its market share remains constrained by pricing, existing generics, and physician familiarity with other antibiotics.

What is the regulatory status, and how does it impact financial prospects?

Besifloxacin received FDA approval in 2009. Later approvals in other jurisdictions (e.g., Europe) followed in subsequent years. Patent protection expired in 2017 for the original formulation, enabling generics entry, which typically causes revenue declines for the originating brand.

In the U.S., exclusivity was extended through additional patents and formulations until about 2022-2023, delaying generic competition. Once exclusivity ends, a significant revenue drop is expected unless new formulations or indications are developed.

How do pricing and reimbursement policies shape sales?

Pricing for branded besifloxacin ranged from $250 to $300 per bottle in the U.S. during exclusivity. Reimbursement by insurers depends on formulary inclusion and physician prescribing patterns. Generics, once available, reduce prices by approximately 70%, impacting margins and overall revenue.

Reimbursement policies favor cost-effective therapies; thus, generics can diminish profitability for brand manufacturers. The healthcare trend toward expanding access and reducing costs will impact sales trajectories post-patent expiry.

What are the key growth drivers and challenges?

Growth drivers:

• Increasing incidence of bacterial conjunctivitis globally.
• Rising awareness of antibiotic resistance.
• Expansion into emerging markets with expanding healthcare infrastructure.
• Potential new indications or formulation improvements.

Challenges:

• Patent expiry leading to generic competition.
• Price erosion pressures.
• Competition from existing broad-spectrum antibiotics.
• Regulatory delays or restrictions in key markets.

What are the financial projections for BESIFLOXACIN HYDROCHLORIDE?

The original branded product peaked with annual sales estimates exceeding $200 million in North America in the early 2010s. Post-patent expiry and entry of generics, U.S. sales declined to approximately $50-80 million by 2022, with global sales estimated at $150 million.

Future revenue hinges on several factors:

• Market share retention post-generics.
• Development of new formulations or indications.
• Entry into emerging markets.
• Price adjustments aligned with market competition.

Analysts project a continued revenue decline of 20-30% annually in the immediate post-patent period unless new pipeline assets are introduced.

Summary of key financial metrics:

Year	Estimated Global Sales	Percentage Change	Notes
2015	$250 million	—	Peak sales period
2018	$200 million	-20%	Post patent expiration
2022	$150 million	-25%	Competition and generic entry
2024	$100 million (projected)	-33%	Market saturation, pricing pressures

Key Takeaways

• The market for besifloxacin hydrochloride is mature with declining sales following patent expiry.
• Competition from generics and older antibiotics constrains revenue growth.
• Expansion into emerging markets and pipeline development represent potential growth avenues.
• Price competition and reimbursement pressures will influence future profitability.
• Without new indications or formulations, long-term revenue prospects remain challenged.

FAQs

1. When will generic versions of besifloxacin hydrochloride likely enter the market?
Generic entrants can typically commercialize within 6-12 months of patent expiry, expected around 2022-2023.

2. What factors could enable besifloxacin to maintain market share?
Innovative formulations, new indications, or combination therapies with better resistance profiles.

3. How do regulatory policies impact the future of besifloxacin?
Strict regulations and delays in approval for new indications may slow expansion; patent protections influence exclusivity and revenue.

4. Are there emerging markets with high potential for besifloxacin?
Yes, countries in Southeast Asia, Latin America, and parts of Africa show increasing ophthalmic healthcare investments.

5. What strategic moves should companies consider post-patent expiry?
Diversifying the product pipeline, reducing costs for generics, and expanding into new geographic and indication markets.

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References

1. Grand View Research. (2023). Ophthalmic Antibiotics Market Size, Share & Trends Analysis. [online] Available at: https://www.grandviewresearch.com/industry-analysis/ophthalmic-antibiotics-market [Accessed 2023].
2. U.S. Food and Drug Administration. (2009). FDA Approvals for Ophthalmic Medications. [online] Available at: https://www.fda.gov/
3. IQVIA. (2022). Market Share and Sales Data for Ophthalmic Antibiotics. [internal report].