NDAOPHTHALMICOINTMENT2 Generics Approved
Approved
Nov 1981
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
3/8 — Basic
TOBREX (tobramycin) by Novartis. Approved for aminoglycoside antibacterial [epc]. First approved in 1981.
Drug data last refreshed 36m ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TOBREX is a topical ophthalmic ointment formulation of tobramycin, an aminoglycoside antibiotic used to treat bacterial eye infections. It works by inhibiting bacterial protein synthesis, making it effective against a broad spectrum of gram-negative and gram-positive ocular pathogens. This is a mature, well-established product in the eye care market.
LOE Approaching
As a mature ophthalmic product approaching loss of exclusivity, TOBREX likely operates with a lean, stable commercial team focused on retention rather than growth.
Mechanism of Action
Pharmacologic Class:
Aminoglycoside Antibacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Tobramycin Injection to Prevent Infection in Open Fractures
Started Jan 2022
600 enrolled
Wound InfectionFractures, OpenSurgical Site Infection
Safety and Efficacy in Patients Treated for Hip or Knee PJI With Vancomycin and Tobramycin Joint Irrigation
Started Oct 2018
15 enrolled
Prosthetic Joint Infection
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
Started Jul 2017
40 enrolled
Ototoxicity
Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Started Feb 2017
107 enrolled
Non-cystic Fibrosis Bronchiectasis
Addition of Tobramycin Inhalation in the Treatment of Ventilator Associated Pneumonia
Started Mar 2015
80 enrolled
Ventilator Associated Pneumonia (VAP)
Worked on TOBREX at Novartis? Share your interview experience or compensation data (+7 days Pro)
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.