NDAINJECTIONINJECTABLE
Approved
Aug 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
CELLCEPT (mycophenolate mofetil hydrochloride) by Roche is (mmf) is absorbed following oral administration and hydrolyzed to mycophenolic acid (mpa), the active metabolite. First approved in 1998.
Drug data last refreshed 8h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CELLCEPT (mycophenolate mofetil hydrochloride) is an immunosuppressant small molecule that inhibits inosine monophosphate dehydrogenase (IMPDH) to block de novo guanosine nucleotide synthesis in lymphocytes. It is used to prevent organ transplant rejection by suppressing T- and B-cell proliferation and reducing inflammatory cytokine production. The drug acts through multiple pathways including suppression of Akt/mTOR and STAT5 signaling, enhancement of negative co-stimulatory markers (PD-1, CTLA-4), and inhibition of leukocyte adhesion and recruitment.
LOE Approaching
Product is in mature phase approaching loss of exclusivity with moderate competitive pressure (30), indicating potential workforce restructuring and shift toward cost-optimization 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…
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.