Viewing data from:

TOBRADEX ST

NDA

DEXAMETHASONE; TOBRAMYCIN | N050818 | HARROW EYE LLC

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

Today

7795316

Aug. 3, 2028

8101582

Dec. 19, 2027

8450287

Dec. 19, 2027

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Tobradex St (2023)

Total Spending

$3.7M

Total Claims

13,756

Beneficiaries

10,925

Avg Cost/Unit

$50.74

Spending Trend

$1.3M(2021)→$3.6M(2022)→$3.7M(2023)

YoY Change:+1.2%

5yr CAGR:+1.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 17, 2022	SUPPL -7	View Letter (PDF)
Aug 17, 2022	SUPPL -8	View Letter (PDF)
Aug 17, 2022	SUPPL -9	View Letter (PDF)
Feb 18, 2009	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.05%;0.3%

RLD

3 patents0 exclusivities▴

SUSPENSION/DROPS;OPHTHALMIC | Approved: Feb 13, 2009

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7795316	Aug 3, 2028	—	—	Yes		—
8101582	Dec 19, 2027	—	—	Yes		—
8450287	Dec 19, 2027	—	—	Yes	—	—