NDAORALTABLETPriority Review
Approved
Jun 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
CELLCEPT (mycophenolate mofetil) by Roche is (mmf) is absorbed following oral administration and hydrolyzed to mycophenolic acid (mpa), the active metabolite. First approved in 1997.
Drug data last refreshed 2d ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CellCept (mycophenolate mofetil) is an oral immunosuppressant approved in 1997 that works by selectively inhibiting inosine monophosphate dehydrogenase (IMPDH) to block guanosine nucleotide synthesis in lymphocytes. It is used primarily for prevention of organ rejection in transplant recipients and treatment of autoimmune conditions. MPA shifts T and B lymphocytes from a proliferative to catabolic state, reducing antibody production and inflammatory cytokine release.
$0.005BPart D
LOE ApproachingProduct is approaching loss of exclusivity with modest Part D volume, signaling transition from growth to maintenance-mode commercial operations.
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…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.