NDAORALSOLUTION
Approved
Nov 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
15
Data completeness
4/8 — Partial
ROCALTROL (calcitriol) by AbbVie is clinical pharmacology man's natural supply of vitamin d depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin d 3 (cholecalciferol). First approved in 1998.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROCALTROL (calcitriol) is the active form of vitamin D3, a hormone analog that regulates calcium and phosphorus metabolism. It is indicated for patients with renal failure who cannot adequately synthesize calcitriol endogenously, leading to hypocalcemia and secondary hyperparathyroidism. The drug works by binding to calcitriol receptors in the intestine and bone to stimulate calcium absorption and correct metabolic bone disease.
$0.037BPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare spending ($37K in 2023), indicating a mature asset with limited growth runway and likely smaller brand team.
Mechanism of Action
CLINICAL PHARMACOLOGY Man's natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol in the skin to vitamin D 3 (cholecalciferol). Vitamin D 3 must be metabolically activated in the liver and the kidney before it is fully…
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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.