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 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a corticosteroid ophthalmic suspension administered as eye drops that reduces inflammation by inhibiting phospholipase A2 and suppressing prostaglandin and leukotriene production. It is indicated for seasonal allergic conjunctivitis and post-operative inflammation, with rapid onset of symptom relief within 2 hours. The drug is structurally modified to undergo predictable metabolism to inactive carboxylic acid metabolites, minimizing systemic absorption.
$11MPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D spending ($11M) and limited claims volume, suggesting mature market positioning with declining team investment potential.
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.