NDAORALELIXIR
Approved
Dec 1959
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
PROLIXIN (fluphenazine hydrochloride) by Bristol Myers Squibb is clinical pharmacology fluphenazine hydrochloride has activity at all levels of the central nervous system as well as on multiple organ systems. Approved for the management of manifestations of psychotic disorders. First approved in 1959.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROLIXIN (fluphenazine hydrochloride) is a first-generation antipsychotic administered orally as an elixir for managing psychotic disorder manifestations. The exact mechanism of action remains unclear, though it exerts activity across multiple CNS levels and organ systems.
LOE Approaching
Product nearing loss of exclusivity with moderate competitive pressure (30%), indicating potential downsizing of commercial team and shifting focus to cost management.
Mechanism of Action
CLINICAL PHARMACOLOGY Fluphenazine hydrochloride has activity at all levels of the central nervous system as well as on multiple organ systems. The mechanism whereby its therapeutic action is exerted is unknown.
Indications (1)
Career Relevance
Working on PROLIXIN offers limited career growth given its LOE-approaching status and generic competition; roles focus on defensive commercial strategies, cost management, and supply chain optimization rather than innovation. This assignment suits professionals seeking stable, low-pressure environments or those transitioning toward generics or manufacturing specialization.
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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.