NDAORALCAPSULEPriority Review
Approved
Dec 1987
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
Priority Review
ACTIGALL (ursodiol) by Teva is clinical pharmacology about 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. First approved in 1987.
Drug data last refreshed 13h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIGALL (ursodiol) is an oral bile acid that suppresses hepatic cholesterol synthesis and inhibits intestinal cholesterol absorption. It is primarily indicated for dissolving gallstones and preventing their recurrence in patients with functioning gallbladders. The drug works by altering bile composition to reduce cholesterol saturation, enabling gradual stone dissolution.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30), the brand team is likely focused on defending market share against generics rather than expanding indications or headcount.
Mechanism of Action
CLINICAL PHARMACOLOGY About 90% of a therapeutic dose of ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from portal blood by the liver (i.e., there is a large "first-pass" effect) where it is…
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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.