NDAORALTABLETPriority Review
Approved
Jun 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
Priority Review
CELLCEPT (mycophenolate mofetil) by Roche is (mmf) is absorbed following oral administration and hydrolyzed to mycophenolic acid (mpa), the active metabolite. Approved for kidney transplantation, lupus nephritis, liver transplantation and 1 more indications. First approved in 1997.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELLCEPT (mycophenolate mofetil) is an oral immunosuppressant used to prevent organ rejection in kidney, heart, and liver transplant recipients. It works by selectively inhibiting inosine monophosphate dehydrogenase (IMPDH) to block guanosine nucleotide synthesis, suppressing T- and B-lymphocyte proliferation and reducing inflammatory cytokine production.
$5MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest Part D spending ($5M) and limited claims (2,327 in 2023), signaling mature market presence and smaller commercial team focus.
Mechanism of Action
(MMF) is absorbed following oral administration and hydrolyzed to mycophenolic acid (MPA), the active metabolite. MPA is a selective uncompetitive inhibitor of the two isoforms (type I and type II) of inosine monophosphate dehydrogenase (IMPDH) leading to inhibition of the de novo pathway of…
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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.