NDAOPHTHALMICOINTMENT
Approved
Sep 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
5/8 — Partial
TOBRADEX (tobramycin and dexamethasone) by Novartis is corticosteroid hormone receptor agonists [moa]. Approved for corticosteroid [epc]. First approved in 1988.
Drug data last refreshed 19m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBRADEX is a fixed-dose ophthalmic ointment combining tobramycin (antibiotic) and dexamethasone (corticosteroid) for treating bacterial eye infections with inflammation. It works via corticosteroid hormone receptor agonism to reduce inflammation while the antibiotic addresses bacterial pathogens. The combination targets patients with moderate-to-severe ocular bacterial infections requiring dual anti-inflammatory and antimicrobial action.
$0.017BPart D
LOE ApproachingDeclining
Product is approaching loss of exclusivity with minimal Part D spending ($17K in 2023), indicating a mature, declining franchise with contracting commercial team investment.
Mechanism of Action
Corticosteroid Hormone Receptor Agonists
Pharmacologic Class:
Corticosteroid
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (8)
A Study to Evaluate the Clinical Efficacy and Safety of Tobradex® ST Compared to Azasite® in the Treatment of Subjects With Moderate to Severe Chronic Blepharitis
Started Apr 2010
122 enrolled
Blepharitis
Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis
Started Oct 2009
357 enrolled
ConjunctivitisKeratitisBlepharitis
TOBRADEX Ophthalmic Suspension Versus Tobramycin 0.3%/Dexamethasone 0.05% Ophthalmic Suspension
Started Oct 2007
221 enrolled
Ocular Inflammation Associated With Blepharaconjunctivitis
Zylet vs TobraDex in Blepharokeratoconjunctivitis
Started Jan 2007
276 enrolled
Blepharokeratoconjunctivitis
Tobradex BID Compared to TOBRADEX and TOBREX/Vehicle
Started Dec 2006
0Post-surgical Inflammation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.