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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 is one patent protecting this drug and one Paragraph IV challenge.

This drug has forty-nine patent family members in twenty-eight countries.

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:1
Applicants:1
NDAs:4
Suppliers / Packagers: see list15

Pharmacology for Tradename: CELLCEPT

Clinical Trials for: CELLCEPT

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

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

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

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

Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis
Status: Not yet recruiting Condition: Interstitial Lung Disease; ILD; Systemic Sclerosis; Scleroderma

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

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)

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

Mycophenolate Mofetil for Reducing Cardiovascular Risk in Renal Transplant Recipients
Status: Terminated Condition: Kidney Transplantation; Cardiovascular Diseases

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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;ORAL050722-001May 3, 1995RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 1997RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 1998RXYes<disabled><disabled>
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 1998RXYes5,688,529<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

International Patent Family for Tradename: CELLCEPT

Country Document Number Publication Date
Germany69434474Oct 06, 2005
Hungary9600838May 28, 1996
Brazil9407728Feb 12, 1997
Latvia11428Aug 20, 1996
European Patent Office0722294Mar 20, 2002
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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