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 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOTEMAX (loteprednol etabonate) is a topical ophthalmic corticosteroid suspension administered as eye drops that reduces ocular inflammation by inhibiting phospholipase A2 and suppressing prostaglandin and leukotriene biosynthesis. It treats post-operative anterior chamber inflammation, giant papillary conjunctivitis, seasonal allergic conjunctivitis, and uveitis. The drug undergoes rapid hepatic metabolism to inactive metabolites with minimal systemic absorption.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team restructuring and transition to defensive commercial strategies.
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.