NDAORALTABLETPriority Review
Approved
Jun 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
PARLODEL (bromocriptine mesylate) by Aurobindo Pharma is clinical pharmacology bromocriptine mesylate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors. Approved for dysfunctions associated with hyperprolactinemia including amenorrhea with, without galactorrhea, infertility and 7 more indications. First approved in 1978.
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Bromocriptine mesylate is an oral dopamine receptor agonist approved in 1978 for treating hyperprolactinemia-related disorders and Parkinson's disease. It works by directly activating post-synaptic dopamine receptors in the tuberoinfundibular pathway and corpus striatum, reducing prolactin secretion and improving motor control. The drug addresses multiple endocrine and neurological indications including amenorrhea, infertility, prolactin-secreting adenomas, acromegaly, and Parkinson's disease.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating reduced commercial investment and team contraction likely underway.
Mechanism of Action
CLINICAL PHARMACOLOGY Bromocriptine mesylate is a dopamine receptor agonist, which activates post-synaptic dopamine receptors. The dopaminergic neurons in the tuberoinfundibular process modulate the secretion of prolactin from the anterior pituitary by secreting a prolactin inhibitory factor…
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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.