NEORAL
LOE ApproachingNDAORALCAPSULE
Approved
Jun 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
NEORAL by Novartis is clinical pharmacology cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung. Approved for organ rejection in kidney, liver, heart allogeneic transplants and 2 more indications. First approved in 1997.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEORAL (cyclosporine) is an oral immunosuppressant that potently inhibits T-lymphocytes by blocking cell cycle progression in the G0-G1 phase, preventing interleukin-2 production. It is indicated for prevention of organ rejection in kidney, liver, and heart allogeneic transplants, as well as rheumatoid arthritis inadequately responsive to methotrexate. The modified formulation (Neoral) offers superior bioavailability (20-50% higher AUC, 40-106% higher peak concentrations) compared to the original Sandimmune formulation.
LOE Approaching
Product nearing loss of exclusivity with minimal spending ($1M reported), indicating reduced commercial team investment and declining career growth opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Cyclosporine is a potent immunosuppressive agent that in animals prolongs survival of allogeneic transplants involving skin, kidney, liver, heart, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a…
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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.