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 3h 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 inhibiting inosine monophosphate dehydrogenase (IMPDH), selectively blocking lymphocyte proliferation and guanosine nucleotide synthesis. It is used to prevent organ rejection in transplant recipients and treat autoimmune conditions by inducing an anergic state in T-cells and reducing pro-inflammatory cytokine production. The mechanism is cytostatic and reversible, making it a cornerstone agent in transplantation and immunology.
$0.005BPart D
LOE ApproachingProduct is in late lifecycle with modest Part D claims, indicating a mature, stable franchise with consolidating commercial teams.
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.