NDAORALTABLETPriority Review
Approved
Mar 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
SALAGEN (pilocarpine hydrochloride) by Orasis Pharmaceuticals is clinical pharmacology: pharmacodynamics: pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. First approved in 1994.
Drug data last refreshed 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SALAGEN (pilocarpine hydrochloride) is an oral cholinergic parasympathomimetic agent approved for treating xerostomia (dry mouth) in head and neck cancer patients and Sjögren's syndrome, as well as vaginal dryness. It works by stimulating muscarinic receptors to increase secretion from exocrine glands including salivary, lacrimal, and sweat glands. The drug increases salivary flow within 20 minutes of oral administration with peak effect at 1 hour and duration of 3-5 hours.
$43,000Part D
LOE ApproachingDeclining
As an older small-molecule drug approaching loss of exclusivity with minimal Part D claims, SALAGEN likely supports a small commercial team focused on managed care and specialty pharmacy channels.
Mechanism of Action
CLINICAL PHARMACOLOGY: Pharmacodynamics: Pilocarpine is a cholinergic parasympathomimetic agent exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. Pilocarpine, in appropriate dosage, can increase secretion by the exocrine glands. The sweat, salivary, lacrimal,…
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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.