Viewing data from:

SIMBRINZA

NDA

BRIMONIDINE TARTRATE; BRINZOLAMIDE | N204251 | ALCON LABORATORIES INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

2030

2031

Today

9044484

Oct. 30, 2030

9421265

Jun. 17, 2030

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
Alcon Inc. et al v. Padagis Israel Pharmaceuticals Ltd. et al 1:2022cv01422 2 patentsANDA 212137brinzolamide/brimonidine tartrate	D. Del.	2022-10-27	Terminated 2025-02-11	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

9 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%NCT01297920	Phase 3	Completed	Alcon Research	1,062	2011-03 → 2012-06
A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%NCT01426867	Phase 2	Completed	Alcon Research	103	2011-09 → 2011-11
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension NCT01309204	Phase 3	Completed	Alcon Research	1,184	2011-05 → 2013-01
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension NCT01310777	Phase 3	Completed	Alcon Research	771	2011-05 → 2013-01
24-hr Intraocular Pressure Control With SIMBRINZA ®NCT02770248	Phase 4	Completed	Alcon Research	162	2016-05-23 → 2017-01-14
Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%NCT01297517	Phase 3	Completed	Alcon Research	1,001	2011-02 → 2012-03
SIMBRINZA® Suspension BID as an Adjunctive to Prostaglandin Analogue (PGA)NCT02419508	Phase 4	Completed	Alcon Research	290	2015-08-07 → 2018-02-27
Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination NCT00961649	Phase 2	Terminated	Alcon Research	195	2009-10 → 2010-02
Safety and Efficacy of SIMBRINZA® BID as an Adjunctive to DUOTRAV®NCT02730871	Phase 4	Terminated	Alcon Research	173	2016-06-24 → 2018-07-13

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$26.04

per ml

Lowest NADAC/Unit

$26.04

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00065414727SIMBRINZA 1%-0.2% EYE DROP	$26.04	ML	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$143.19

Highest Price

$148.10

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00065-4147-27SIMBRINZA 1%/0.2% SUSP,OPH	$148.10	FSS	Alcon Vision, LLC	09/23/2026
00065-4147-27SIMBRINZA 1%/0.2% SUSP,OPH	$143.19	Big4	Alcon Vision, LLC	09/23/2026

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

Medicare Part D Spending

CMS annual spending data for Simbrinza (2024)

Total Spending

$78.9M

Total Claims

301,984

Beneficiaries

74,537

Avg Cost/Unit

$25.05

Spending Trend

$71.9M(2019)→$69.4M(2020)→$64.7M(2021)→$67.8M(2022)→$75.6M(2023)→$78.9M(2024)

YoY Change:-3.6%

5yr CAGR:+3.7%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 8, 2023	SUPPL -12	View Letter (PDF)
Nov 9, 2015	SUPPL -6	View Letter (PDF)
Apr 24, 2013	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.2%;1%

RLD

2 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Apr 19, 2013

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
9044484	Oct 30, 2030	—	—	Yes	—	—
9421265	Jun 17, 2030	—	—	Yes	—	—