NDAORALCAPSULE
Approved
Jan 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
EVOXAC (cevimeline hydrochloride) by Aurobindo Pharma is clinical pharmacology pharmacodynamics cevimeline is a cholinergic agonist which binds to muscarinic receptors. Approved for xerostomia. First approved in 2000.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
EVOXAC (cevimeline hydrochloride) is an oral cholinergic agonist that binds to muscarinic receptors to stimulate salivary gland secretion. It treats xerostomia (dry mouth) in Sjögren's Syndrome and head and neck cancer patients by increasing exocrine gland function. The drug is administered as 30 mg capsules three times daily, achieving peak plasma concentration within 1.5–2 hours.
$0.001BPart D
LOE ApproachingDeclining
Mature product approaching loss of exclusivity with modest Medicare utilization (968 Part D claims in 2023); brand teams should prepare for generic transition and focus on niche positioning.
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.