NDAORALCAPSULEPriority Review
Approved
May 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — 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 1995.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CellCept (mycophenolate mofetil) is an oral immunosuppressant that selectively inhibits inosine monophosphate dehydrogenase (IMPDH), blocking de novo guanosine nucleotide synthesis to suppress T- and B-lymphocyte proliferation. It is primarily indicated for prevention of organ rejection in transplant patients and is used across solid organ transplantation (kidney, heart, liver). The drug works by shifting lymphocyte transcriptional activity from proliferation to catabolism, inducing an anergic state that reduces immune responsiveness to allogeneic antigens.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%); brand team focus shifting toward lifecycle extension and generic transition planning.
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.