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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Simbrinza (2023)

Total Spending

$75.6M

Total Claims

277,999

Beneficiaries

68,879

Avg Cost/Unit

$25.98

Spending Trend

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

YoY Change:+5.3%

5yr CAGR:+6.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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	—	—