NDAORALTABLET, DELAYED RELEASE
Approved
Feb 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
Drug data last refreshed 1h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYFORTIC (mycophenolic acid) is an oral immunosuppressant that inhibits inosine monophosphate dehydrogenase (IMPDH), blocking de novo guanosine nucleotide synthesis and selectively suppressing T- and B-lymphocyte proliferation. It is approved for prevention of organ rejection in kidney, heart, and liver transplant patients, with emerging evidence in autoimmune conditions including lupus nephritis and systemic sclerosis. The drug's selective action on lymphocytes while sparing other cell types via salvage pathways provides a differentiated safety profile in transplant and autoimmune settings.
$0.001BPart D
LOE ApproachingDeclining
Product approaching loss of exclusivity with modest Part D utilization signals a contracting commercial footprint and potential team right-sizing.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis
Started Mar 2021
72 enrolled
Lupus Nephritis
A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease
Started Jan 2021
349 enrolled
Dry Eye Disease
Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A
Started May 2014
186 enrolled
Transplantation InfectionCytomegalovirus Infection
Conversion to Everolimus From Calcineurin Inhibitor With Mycophenolic Acid: Impact on Long Term Renal Function in Liver Transplantation.
Started Dec 2013
24 enrolled
ImmunosuppressionRenal Failure
A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)
Started Apr 2013
100 enrolled
Renal Transplantation
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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.