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. Approved for cardiac glycoside [epc]. First approved in 2004.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Digoxin is an oral cardiac glycoside elixir indicated for heart failure and atrial fibrillation management. It works by increasing cardiac contractility and slowing AV node conduction, improving heart function in patients with reduced ejection fraction or rate control needs.
LOE Approaching
Product approaches loss of exclusivity with moderate competitive pressure (60%), suggesting focused brand defense and potential team transition planning.
Mechanism of Action
Pharmacologic Class:
Cardiac Glycoside
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Phase 1 Study to Assess the Effect of ABBV-722 on Midazolam, Digoxin, Pitavastatin, Metformin, and Sitagliptin Drug Levels in Healthy Adults.
Started Apr 2026
12 enrolled
Healthy Volunteers
A Study in Healthy People to Test Whether BI 3000202 Affects How 2 Other Medicines (Rosuvastatin and Digoxin) Are Taken up in the Body
Started Nov 2025
14 enrolled
Healthy
A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
Started Sep 2025
62 enrolled
Healthy Volunteers
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Digoxin and Rosuvastatin
Started Apr 2025
38 enrolled
Healthy Volunteer Study
PK/PD of Digoxin in Infants With SVHD
Started Oct 2024
24 enrolled
Single-ventricleInfant ConditionsInfant, Newborn, Diseases+1 more
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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.