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Generic Name: SIROLIMUS

Summary for Generic Name: SIROLIMUS

Tradenames:2
Patents:3
Applicants:2
NDAs:3
Drug Master File Entries: see list14
Suppliers: see list3
Formulation / Manufacturing:see details

Pharmacology for Ingredient: SIROLIMUS

Tentative approvals for SIROLIMUS

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG
<disabled><disabled>TABLET; ORAL2MG
<disabled><disabled>TABLET; ORAL1MG

Clinical Trials for: SIROLIMUS

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose of Sirolimus in Healthy Subjects
Status: Completed Condition: Healthy Subjects; Pharmacokinetics of Isavuconazole; Pharmacokinetics of Sirolimus

Sirolimus for Autoimmune Disease of Blood Cells
Status: Recruiting Condition: Autoimmune Pancytopenia; Autoimmune Lymphoproliferative Syndrome (ALPS); Evans Syndrome; Idiopathic Thrombocytopenic Purpura; Anemia, Hemolytic, Autoimmune; Autoimmune Neutropenia; Lupus Erythematosus, Systemic; Inflammatory Bowel Disease; Rheumatoid Arthritis

RAD001 Plus Best Supportive Care (BSC) Versus BSC Plus Placebo in Patients With Metastatic Carcinoma of the Kidney Which Has Progressed After Treatment With Sorafenib and/or Sunitinib
Status: Completed Condition: Metastatic Renal Cell Carcinoma

Sirolimus or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
Status: Recruiting Condition: Advanced Cancer

Trial of RAD001 and Neurocognition in Tuberous Sclerosis Complex (TSC)
Status: Recruiting Condition: Tuberous Sclerosis Complex

Efficacy of Sirolimus In Liver Transplantation for Hepatocellular Carcinoma (HCC)
Status: Recruiting Condition: Hepatocellular Carcinoma

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. Patented / Exclusive Use
Zydus Pharms Usa Inc
SIROLIMUS
sirolimus
TABLET;ORAL201676Jan 8, 2014RXNo<disabled>PATENT CHALLENGE
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Feb 23, 2004DISCNNo5,989,591*PED<disabled>Y
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Feb 23, 2004DISCNNo5,100,899*PED<disabled>Y
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Aug 22, 2002RXYes5,989,591*PED<disabled>Y
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