NDAORALCAPSULE
Approved
May 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ELDEPRYL (selegiline hydrochloride) by Gen Pharmaceuticals is clinical pharmacology the mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of parkinson's disease are not fully understood. Approved for cognitive disorders. First approved in 1996.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ELDEPRYL (selegiline hydrochloride) is an oral selective monoamine oxidase type B inhibitor approved in 1996 as an adjunctive treatment for Parkinson's disease and cognitive disorders. It works by irreversibly inhibiting MAO-B enzyme activity, increasing dopaminergic neurotransmission in the brain and potentially enhancing cognitive function through multiple mechanisms including dopamine reuptake interference.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30) signals transition from growth-stage team structures toward generic defense and lifecycle extension strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of Parkinson's disease are not fully understood. Inhibition of monoamine oxidase, type B, activity is generally considered to be of primary importance; in addition, there is evidence that…
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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.