ROSZET
Peakezetimibe; rosuvastatin calcium
NDAORALTABLET
Approved
Mar 2021
Lifecycle
Peak
Competitive Pressure
0/100
Data completeness
3/8 — Basic
ROSZET (ezetimibe; rosuvastatin calcium) is intestine. First approved in 2021.
Drug data last refreshed 58m ago · AI intelligence enriched 5h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ROSZET is a fixed-dose combination tablet containing ezetimibe and rosuvastatin calcium, indicated for lipid management in patients with hypercholesterolemia. Ezetimibe inhibits cholesterol absorption at the intestinal brush border via NPC1L1 blockade, while rosuvastatin reduces hepatic cholesterol synthesis. This dual mechanism provides synergistic LDL-lowering efficacy.
Peak6.5 years to LOE
Product is in peak commercial phase with stable market position and no active biosimilar competition, supporting sustained team investment.
Mechanism of Action
intestine. The molecular target of ezetimibe has been shown to be the sterol transporter, Niemann-Pick C1-Like 1 (NPC1L1), which is involved in the intestinal uptake of cholesterol and phytosterols. Ezetimibe localizes at the brush border of the small intestine and inhibits the absorption of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on ROSZET offers exposure to mature product commercialization in the high-volume cardiovascular/lipid space, with focus on market share defense and payer relationships. The 6.5-year patent runway provides medium-term job stability but requires strategic LOE planning skill development.
Brand Manager
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.