NDAORALELIXIR2 Generics Approved
Approved
Aug 2004
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
20
Data completeness
4/8 — Partial
DIGOXIN (digoxin) by Hikma is digoxin's actions are mediated through its effects on nak–atpase. First approved in 2004.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Digoxin is a cardiac glycoside small molecule that inhibits the sodium-potassium ATPase pump, increasing intracellular calcium in the myocardium to improve cardiac contractility. It is indicated for heart failure and atrial fibrillation, working through both direct positive inotropic effects and indirect parasympathetic stimulation. The drug has a narrow therapeutic window requiring careful dosing and monitoring.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (60%), indicating shifting focus toward cost management and transition planning rather than market growth initiatives.
Mechanism of Action
digoxin's actions are mediated through its effects on NaK–ATPase. This enzyme, the "sodium pump," is responsible for maintaining the intracellular milieu throughout the body by moving sodium ions out of and potassium ions into cells. By inhibiting NaK–ATPase, digoxin • causes increased availability…
Pharmacologic Class:
Cardiac Glycoside
Indications
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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.