NEORAL
LOE ApproachingNDAORALCAPSULE
Approved
May 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 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEORAL (cyclosporine) is a potent oral immunosuppressive agent that works by selectively inhibiting T-lymphocytes in the G0-G1 phase of the cell cycle. 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% greater AUC, 40-106% greater peak concentration) compared to earlier cyclosporine formulations.
LOE Approaching
Product approaching loss of exclusivity with minimal recent spending ($1M reported), indicating a mature brand in transition requiring restructured commercial support and defensive strategies.
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.