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 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a corticosteroid ophthalmic suspension designed to reduce ocular inflammation and allergic symptoms in the eye. It works by inhibiting phospholipase A2, thereby suppressing prostaglandin and leukotriene production and the inflammatory cascade. The drug is notable for its ester structure that allows rapid metabolism to inactive compounds, minimizing systemic exposure.
$11MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Part D spend of $11M in 2023, indicating a mature, stable franchise likely supporting a lean brand team focused on retention and lifecycle management.
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.