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BROMSITE

NDA

BROMFENAC SODIUM | N206911 | SUN PHARMACEUTICAL INDUSTRIES LTD

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

2029

Today

RE50218

Mar. 5, 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
SUN PHARMACEUTICAL INDUSTRIES LTD. et al v. LUPIN LIMITED et al 3:2018cv02213 1 patentbromfenac ophthalmic solution	D.N.J.	2018-02-15	Terminated 2021-09-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 4 - Draft Guidance on Bromfenac Sodium RE Suitability Petition fro... FDA-2023-P-4359 · 11 docket documents Pharmobedient Consulting, LLC filed a petition regarding bromfenac sodium requesting FDA guidance on the suitability of the drug substance for use in abbreviated new drug applications (ANDAs), specifically addressing regulatory reference eligibility and quality standards.	Suitability	2023-10-05	Denied	Pharmobedient Consulting, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

38 trials from ClinicalTrials.gov, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase NCT00520260	Phase 4	Completed	Florida Eye Microsurgical Institute	42	2007-08 → 2008-08
Aqueous Concentrations and PGE2 Inhibition of Ketorolac 0.4% vs. Bromfenac 0.09% in Cataract Patients NCT00347503	Phase 4	Completed	Innovative Medical	—	—
Prolensa (Bromfenac) 0.07% QD vs. Ilevro (Nepafenac) 0.3% QD for Treatment of Ocular Inflammation Post Cataract Surgery NCT01847638	N/A	Completed	Melissa Toyos	50	2013-04-01 → 2018-08-23
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery NCT00704418	Phase 3	Completed	Bausch & Lomb Incorporated	156	2008-06 → 2009-12
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing Cataract Surgery NCT00853970	Phase 3	Completed	Bausch & Lomb Incorporated	299	2009-02 → 2009-12
A Comparison of Peak Aqueous Penetration of Acuvail (Ketorolac 0.45%), Xibrom (Bromfenac 0.09%), and Nevanac (Nepafenac 0.1%)in Patients Undergoing Phacoemulsification NCT01001806	Phase 4	Completed	Frank A. Bucci, Jr., M.D.	126	2009-10 → 2010-01
A Comparison of Post Phacoemulsification Aqueous Flare in Patients Using Ketorolac 0.45% 2 Times Daily (BID) and Bromfenac 0.09% 2 Times Daily (BID)NCT01023724	Phase 4	Completed	Bucci Laser Vision Institute	50	2009-12 → 2010-02
Safety and Tolerability of PRO-155 Ophthalmic Solution 0.09% in Healthy Volunteers.NCT01535443	Phase 1	Completed	Laboratorios Sophia S.A de C.V.	35	2011-09 → 2011-10
A Dose Ranging Study to Evaluate Safety and Efficacy of Bromfenac Ophthalmic Solution in Dry Eye Disease NCT01212471	Phase 3	Completed	Bausch & Lomb Incorporated	840	2010-09 → 2011-12
PRevention of Macular EDema After Cataract Surgery NCT01774474	Phase 3	Completed	Maastricht University Medical Center	1,127	2013-07-10 → 2016-11-04

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$49.57

per ml

Lowest NADAC/Unit

$23.57

per ml

Brand NDCs

Generic NDCs

Avg Brand: $49.57

Avg Generic: $23.57

52% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49708075441BROMSITE 0.075% EYE DROPS	$49.57	ML	Brand	$23.57	2026-06-17
49708075541BROMFENAC SOD 0.075% EYE DROP	$23.57	ML	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$46.10

Highest Price

$255.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49708-0754-41BROMSITE 0.075% SOLN,OPH	$255.30	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026
49708-0754-41BROMSITE 0.075% SOLN,OPH	$179.13	Big4	Sun Pharmaceutical Industries, Inc.	07/14/2026
49708-0755-41BROMFENAC 0.075% SOLN,OPH	$62.09	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026
49708-0755-41BROMFENAC 0.075% SOLN,OPH	$46.10	Big4	Sun Pharmaceutical Industries, Inc.	07/14/2026

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

Medicare Part D Spending

CMS annual spending data for Bromsite (2024)

Total Spending

$1.4M

Total Claims

5,089

Beneficiaries

2,644

Avg Cost/Unit

$51.67

Spending Trend

$13.4M(2019)→$10.0M(2020)→$9.7M(2021)→$6.6M(2022)→$3.7M(2023)→$1.4M(2024)

YoY Change:-8.3%

5yr CAGR:-1.3%

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Mar 10, 2023	SUPPL -8	View Letter (PDF)
Apr 12, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.075% ACID

RLDAB

1 patent0 exclusivities▴

SOLUTION/DROPS;OPHTHALMIC | Approved: Apr 8, 2016

Patents (1) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
RE50218	Mar 5, 2029	—	—	Yes		—