IOPIDINE
LOE Approachingapraclonidine
NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Jul 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
IOPIDINE (apraclonidine) is clinical pharmacology apraclonidine hydrochloride is a relatively selective alpha-2-adrenergic agonist. First approved in 1993.
Drug data last refreshed 23h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IOPIDINE (apraclonidine) is a relatively selective alpha-2-adrenergic agonist ophthalmic solution that reduces elevated and normal intraocular pressure by decreasing aqueous humor flow. It is indicated for glaucoma patients on maximally tolerated medical therapy with uncontrolled IOP, particularly those scheduled for laser or surgical intervention. Onset of action occurs within one hour with maximum IOP reduction at approximately three hours post-instillation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30% intensity) signals potential team restructuring and shift toward generic preparation or brand extension strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY Apraclonidine hydrochloride is a relatively selective alpha-2-adrenergic agonist. When instilled in the eye, apraclonidine ophthalmic solution 0.5%, has the action of reducing elevated, as well as normal, intraocular pressure (IOP), whether or not accompanied by glaucoma.…
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.