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Profile for Tradename: CELLCEPT

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Cellcept is a drug marketed by Roche Palo and is included in four NDAs. It is available from four suppliers. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in CELLCEPT is mycophenolate mofetil hydrochloride. There are thirty-three drug master file entries for this compound. One supplier is listed for this compound. There is one tentative approval for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for Tradename: CELLCEPT

Patents:2
Applicants:1
NDAs:4
Suppliers: see list4

Pharmacology for Tradename: CELLCEPT

Clinical Trials for: CELLCEPT

Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
Status: Terminated Condition: Stable Renal Transplant Recipients

A Randomized Multicenter Double-Blind CT to Evaluate the Efficacy and Safety of Mycophenolate Mofetil . . .
Status: Terminated Condition: Interstitial Cystitis; Painful Bladder Syndrome

Biomarker-Linked Outcomes of Cellcept in Lupus Arthritis
Status: Completed Condition: Systemic Lupus Erythematosus; Arthritis

Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Status: Completed Condition: Autoimmune Disease

Study of Gastrointestinal Side Effects in African American Kidney Transplant Recipients Treated With CellCept or Myfortic
Status: Terminated Condition: Kidney Transplantation

Influence of Pantoprazole to the Bioavailability of Myfortic® and CellCept®
Status: Recruiting Condition: Immunosuppressive Medication After Renal Transplantation; Concomitant Medication After Renal Transplantation

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)
Status: Not yet recruiting Condition: Renal Transplantation

A Study to Assess the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Mycophenolate Mofetil in Healthy Adult Subjects
Status: Completed Condition: Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Plasma Mycophenolic Acid (MPA); Pharmacokinetics of Plasma Phenolic Glucuronide of MPA (MPAG)

Myfortic vs. Cellcept in Kidney Transplant Recipients
Status: Completed Condition: End Stage Renal Disease

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation
Status: Completed Condition: Renal Transplant

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL050722May 3, 1995RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723Jun 19, 1997RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759Oct 1, 1998RXYes5,688,529<disabled>Y<disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758Aug 12, 1998RXYes5,543,408<disabled>Y<disabled>
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Paragraph IV activity for: CELLCEPT

Drugname Dosage Strength RLD Submissiondate
mycophenolic mofetilFor Oral Suspension200 mg/mLCellcept3/25/2011
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