NDAORALCAPSULEPriority Review
Approved
May 1995
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. Approved for kidney transplantation, heart transplantation, liver transplantation and 2 more indications. First approved in 1995.
Drug data last refreshed 21h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CellCept (mycophenolate mofetil) is an oral immunosuppressant that selectively inhibits inosine monophosphate dehydrogenase to block guanosine nucleotide synthesis and T/B-lymphocyte proliferation. It is indicated for prevention of organ rejection in kidney, heart, and liver transplant recipients, as well as lupus nephritis and other autoimmune conditions. The drug works through a reversible, cytostatic mechanism that shifts lymphocytes from proliferation to catabolism and enhances negative immune co-stimulators.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), signaling potential team contraction and shift toward specialty care and niche indication 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.