NDAOPHTHALMICSOLUTION/DROPS
Approved
Sep 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
6/8 — Strong
BEPREVE (bepotastine besilate) by Bausch + Lomb is active, direct h1-receptor antagonist and an inhibitor of the release of histamine from mast cells. Approved for allergic conjunctivitis. First approved in 2009.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BEPREVE (bepotastine besilate) is an ophthalmic solution that acts as a direct H1-receptor antagonist and mast cell stabilizer for allergic eye conditions. It is indicated for allergic conjunctivitis and related allergic/pruritic conditions affecting the eye. The drug works by blocking histamine release from mast cells and antagonizing H1 receptors to reduce allergic inflammation.
$0.003BPart D
LOE ApproachingDeclining
With LOE approaching and modest Part D spending, the BEPREVE brand team is likely focused on defensive strategy and cost management rather than growth expansion.
Mechanism of Action
active, direct H1-receptor antagonist and an inhibitor of the release of histamine from mast cells.
Indications (1)
Clinical Trials (13)
Bioequivalence Test of "Dong-a Bepotastine Besilate Tab" and "Twolion Tab"
Started Apr 2019
32 enrolled
Healthy
Bepotastine Besilate Nasal Sprays in the Treatment of Seasonal Allergic Rhinitis (SAR)
Started Jan 2013
617 enrolled
Seasonal Allergic Rhinitis
Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
Started Dec 2011
606 enrolled
Seasonal Allergic Rhinitis
The Effect of BEPREVE 1.5% on Tear Film Osmolarity and Tear Film Lipid Layer
Started May 2011
40 enrolled
Allergic Conjunctivitis
Use of BEPREVE (Bepotastine Besilate Ophthalmic Solution) 1.5% for Allergic Conjunctivitis and Contact Lenses
Started May 2011
24 enrolled
Allergic Conjunctivitis
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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.