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

18 trials from ClinicalTrials.gov, 16 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
VisuMax Femtosecond Laser Small Incision Lenticule Extraction for the Correction of High Myopia NCT02528123	N/A	Completed	London Vision Clinic	114	2016-04 → 2020-12-07
Ketorolac Plus Tobramycin/Dexamethasone Versus Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery NCT01103401	N/A	Completed	Veroia General Hospital	145	2009-10 → 2010-01
Early Changes Among FLEx, LASIK and FS-LASIK NCT02551796	N/A	Completed	Sun Yat-sen University	75	2015-09 → 2016-04
Efficacy Comparison of Two Kinds of Treatment in Treating Dry Eye Caused by Meibomian Gland Dysfunction NCT02958514	N/A	Completed	Peking University Third Hospital	20	2016-11 → 2017-03
Tobramycin Tear Concentrations NCT00695435	Phase 1	Completed	Alcon Research	21	2008-06
Tobramycin-Dexamethasone Versus Tobramycin-Dexamethasone Plus Ketorolac After Phacoemulsification Surgery NCT00992355	N/A	Completed	Veroia General Hospital	97	2009-01 → 2009-04
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis NCT01028027	Phase 3	Completed	Bausch & Lomb Incorporated	357	2009-10 → 2010-03
Zylet vs TobraDex in Blepharokeratoconjunctivitis NCT00447577	Phase 4	Completed	Bausch & Lomb Incorporated	276	2007-01 → 2007-06
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension NCT00576251	Phase 3	Completed	Alcon Research	221	2007-10 → 2008-03
Bromfenac to Reduce Inflammation in Patients With Pseudoexfoliation Syndrome After Cataract Surgery NCT02137161	Phase 4	Completed	Azienda USL Reggio Emilia - IRCCS	62	2013-11 → 2014-10

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$46.67

per ml

Lowest NADAC/Unit

$46.67

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
82667001105TOBRADEX ST 0.3-0.05% EYE DROP	$46.67	ML	Brand	—	2026-06-17
71776003505TOBRADEX ST 0.3-0.05% EYE DROP	$46.67	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 (2 FSS)

Lowest Price

$181.37

Highest Price

$181.37

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
82667-0011-05TOBRADEX ST	$181.37	FSS	Harrow Eye, LLC	03/14/2029
71776-0035-05TOBRADEX ST	$181.37	FSS	Harrow Eye, LLC	03/14/2029

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

Medicare Part D Spending

CMS annual spending data for Tobradex St (2024)

Total Spending

$6.0M

Total Claims

24,550

Beneficiaries

19,670

Avg Cost/Unit

$46.45

Spending Trend

$1.3M(2021)→$3.6M(2022)→$3.7M(2023)→$6.0M(2024)

YoY Change:-8.5%

5yr CAGR:-1.7%

Source: CMS Medicare Part D Spending by Drug (2024). 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) · 2 use codes

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	—	—