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 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SALAGEN (pilocarpine hydrochloride) is an oral cholinergic parasympathomimetic agent approved in 1994 for stimulating saliva production in patients with dry mouth (xerostomia). It works by activating muscarinic receptors on exocrine glands, particularly salivary glands, to increase secretion. The drug is indicated for head and neck cancer patients with radiation-induced xerostomia and Sjögren's syndrome patients.
$0.043MPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with minimal Part D claims (~163 in 2023), indicating small patient base and shrinking commercial opportunity.
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.