NDAOPHTHALMICSUSPENSION/DROPS
Approved
Mar 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
16
Data completeness
4/8 — Partial
LOTEMAX (loteprednol etabonate) by Bausch + Lomb is clinical pharmacology corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. First approved in 1998.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a corticosteroid ophthalmic suspension that inhibits inflammatory response by inducing phospholipase A2 inhibitory proteins, reducing prostaglandin and leukotriene mediators. It is formulated as eye drops for treatment of post-operative anterior chamber inflammation, giant papillary conjunctivitis, seasonal allergic conjunctivitis, and uveitis. The drug undergoes extensive hepatic metabolism to inactive carboxylic acid metabolites with minimal systemic absorption.
LOE Approaching
As a product approaching loss of exclusivity in the mature ophthalmic corticosteroid market, LOTEMAX teams are likely focused on defending market share against generics and managing portfolio transition.
Mechanism of Action
CLINICAL PHARMACOLOGY Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen,…
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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.