NDAORALFOR SUSPENSION
Approved
Oct 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
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 1998.
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELLCEPT (mycophenolate mofetil) is an oral immunosuppressant that selectively inhibits lymphocyte proliferation via blockade of guanosine nucleotide synthesis. It is indicated for prevention of organ rejection in kidney and liver transplant patients, and for treatment of lupus nephritis. The drug works by suppressing T- and B-cell activation while promoting regulatory T-cell differentiation through modulation of metabolic pathways (Akt/mTOR, STAT5).
LOE Approaching
Product faces moderate competitive pressure (30%) in a consolidating transplant immunosuppression market with approaching loss of exclusivity, likely resulting in smaller brand team focused on retention and lifecycle extension.
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.