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BESIVANCE

NDA

BESIFLOXACIN HYDROCHLORIDE | N022308 | BAUSCH AND LOMB INC

1 strength4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

Today

Nov. 7, 2030

Jan. 9, 2031

Mar. 12, 2030

Nov. 13, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

10 trials from ClinicalTrials.gov, 9 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Systemic Pharmacokinetics of BOL-303224-A NCT00407589	Phase 1	Completed	Bausch & Lomb Incorporated	24	2006-10 → 2007-10
A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery NCT01296542	Phase 4	Completed	Bucci Laser Vision Institute	60	2011-05 → 2013-01
Assessment of the Concentrations of Besifloxacin, Moxifloxacin, or Gatifloxacin in the Aqueous Humor of Subjects NCT00824070	Phase 1	Completed	Bausch & Lomb Incorporated	105	2009-02 → 2009-08
Besifloxacin in Bacterial Keratitis NCT02497365	N/A	Completed	McGill University Health Centre/Research Institute of the McGill University Health Centre	32	2015-09 → 2019-07
Safety and Efficacy Study of Besivance™ for Treatment of Congenital Nasolacrimal Duct Obstruction in Children NCT01431170	Phase 1	Completed	Rutgers, The State University of New Jersey	24	2011-09 → 2014-06
Aqueous Absorption and Pharmacokinetics of Besivance Versus VIGAMOX in Patients Undergoing Phacoemulsification NCT01296191	Phase 4	Completed	Frank A. Bucci, Jr., M.D.	120	2011-05 → 2013-01
A Study to Investigate the Safety and Efficacy of BOL-303224 in the Treatment of Bacterial Conjunctivitis NCT00348348	Phase 3	Completed	Bausch & Lomb Incorporated	1,161	2006-06 → 2007-07
2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery NCT01455233	Phase 4	Completed	Ophthalmology Consultants, Ltd.	60	2010-09 → 2011-02
Concentration of Besifloxacin, Gatifloxacin, and Moxifloxacin in Human Conjunctiva After Topical Instillation NCT00905762	Phase 1	Completed	Bausch & Lomb Incorporated	119	2009-03 → 2009-04
A Comparison of Three Fluoroquinolone Topical Eyedrops in the Treatment of Infectious Corneal Ulcers.NCT01928693	Phase 2	Terminated	Cornea Consultants Of Nashville	2	2013-07 → 2014-05

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 1 NDC

Highest NADAC/Unit

$44.12

per ml

Lowest NADAC/Unit

$44.12

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24208044605BESIVANCE 0.6% SUSP	$44.12	ML	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$161.72

Highest Price

$161.72

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24208-0446-05BESIVANCE 0.6%	$161.72	Big4	Bausch & Lomb Americas Inc.	09/14/2027
24208-0446-05BESIVANCE 0.6%	$161.72	FSS	Bausch & Lomb Americas Inc.	09/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Besivance (2024)

Total Spending

$6.8M

Total Claims

30,315

Beneficiaries

19,935

Avg Cost/Unit

$44.02

Spending Trend

$33.1M(2019)→$18.0M(2020)→$18.0M(2021)→$14.3M(2022)→$10.6M(2023)→$6.8M(2024)

YoY Change:-2.7%

5yr CAGR:+4.6%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

INDOCO REMEDIES LTDBESIFLOXACIN HYDROCHLORIDE

DMF 293032015

MICRO LABS LTDBESIFLOXACIN HYDROCHLORIDE

DMF 319892017

ALP PHARM BEIJING CO LTDBESIFLOXACIN HYDROCHLORIDE

DMF 326112018

MAITHRI DRUGS PRIVATE LTDBESIFLOXACIN HYDROCHLORIDE

DMF 358092021

RUYUAN HEC PHARM CO LTDInactiveBESIFLOXACIN HYDROCHLORIDE NON-STERILE BULK DRUG SUBSTANCE

DMF 321602017

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 5, 2018	SUPPL -13	View Letter (PDF)
Sep 24, 2012	SUPPL -3	View Letter (PDF)
Jun 2, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.6% BASE

RLD

4 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: May 28, 2009

Patents (4) · 2 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8415342	Nov 7, 2030	—	—	—		—
8481526	Jan 9, 2031	—	Yes	—	—	—
8604020	Mar 12, 2030	—	—	Yes	—	—
8937062	Nov 13, 2029	—	—	—		—