NDASUBCUTANEOUSINJECTABLEPriority Review
Approved
Apr 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3
Data completeness
4/8 — Partial
Priority Review
APOKYN (apomorphine hydrochloride) by Sumitomo Dainippon Pharma is non-ergoline dopamine agonist with high in vitro binding affinity for the dopamine d 4 receptor, and moderate affinity for the dopamine d 2 , d 3 , and d 5 , and adrenergic α 1 d, α 2 b, α 2 c receptors. First approved in 2004.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APOKYN (apomorphine hydrochloride) is a non-ergoline dopamine agonist approved in 2004 for treating motor fluctuations in Parkinson's disease patients. It works by stimulating post-synaptic dopamine D2-type receptors in the brain, with high binding affinity for the D4 receptor and moderate affinity for D2, D3, D5, and adrenergic receptors. Administered subcutaneously, it provides rapid symptom relief during "off" episodes.
$72MPart D
LOE ApproachingMature product with modest Medicare Part D utilization (2,318 claims in 2023) approaching loss of exclusivity, indicating a consolidating commercial footprint and smaller brand team.
Mechanism of Action
non-ergoline dopamine agonist with high in vitro binding affinity for the dopamine D 4 receptor, and moderate affinity for the dopamine D 2 , D 3 , and D 5 , and adrenergic α 1 D, α 2 B, α 2 C receptors. The precise mechanism of action of APOKYN as a treatment for Parkinson's disease is unknown,…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Outpatient Physical Therapy Intervention in Subjects With Parkinson's Disease Currently Using APOKYN®
Started Jan 2016
13 enrolled
Parkinson's DiseaseMotor Symptoms
Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)
Started Dec 2012
127 enrolled
Parkinson's DiseaseMotor SymptomsAkinesia+2 more
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Started May 2007
117 enrolled
Parkinson's Disease
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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.