NDAINJECTIONINJECTABLE
Approved
Aug 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
5/8 — Partial
CELLCEPT (mycophenolate mofetil hydrochloride) by Roche is (mmf) is absorbed following oral administration and hydrolyzed to mycophenolic acid (mpa), the active metabolite. Approved for lung transplant rejection. First approved in 1998.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELLCEPT (mycophenolate mofetil hydrochloride) is an immunosuppressant that inhibits inosine monophosphate dehydrogenase (IMPDH), blocking de novo guanosine nucleotide synthesis in lymphocytes. It is indicated for lung transplant rejection prevention and works through selective suppression of T- and B-cell proliferation, with reversible cytostatic effects. The drug modulates transcriptional pathways (Akt/mTOR, STAT5) and enhances negative co-stimulator expression to induce an anergic state in T-cells.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100); expect transition focus toward lifecycle extension or managed decline strategies.
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.