NDAORALCAPSULE
Approved
Jan 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
EVOXAC (cevimeline hydrochloride) by Aurobindo Pharma is clinical pharmacology pharmacodynamics cevimeline is a cholinergic agonist which binds to muscarinic receptors. First approved in 2000.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EVOXAC (cevimeline hydrochloride) is an oral small-molecule cholinergic agonist approved in 2000 for treating dry mouth in Sjögren's Syndrome patients. It works by binding to muscarinic receptors to increase salivary gland secretion and restore moisture. Clinical evidence shows 76% of patients receiving 30 mg three times daily reported global improvement versus 35% on placebo.
$0.001BPart D
LOE ApproachingMature, niche product with declining market opportunity; brand team likely operating in maintenance mode with minimal headcount expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics Cevimeline is a cholinergic agonist which binds to muscarinic receptors. Muscarinic agonists in sufficient dosage can increase secretion of exocrine glands, such as salivary and sweat glands and increase tone of the smooth muscle in the gastrointestinal and…
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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.