OLYSIO
LOE ApproachingNDAORALCAPSULEPriority Review
Approved
Nov 2013
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OLYSIO is an oral small-molecule capsule approved by the FDA in November 2013 for treatment of hepatitis C virus (HCV) infection. The drug represents a protease inhibitor class therapeutic targeting viral replication machinery. Indication and mechanism details are not fully specified in available data, but the oral route and capsule formulation suggest convenient patient administration.
LOE Approaching2.8 years to LOE
With loss of exclusivity approaching in 2029 and moderate competitive pressure (15), brand teams face urgent transition planning and resource optimization challenges.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Why This Matters for Your Career
LOE in ~3 years — strategic planning for patent cliff underway
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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.