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Profile for Tradename: RAPAMUNE

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Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in RAPAMUNE is sirolimus. There are fifteen drug master file entries for this compound. Three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the sirolimus profile page.

Summary for Tradename: RAPAMUNE

Patents:3
Applicants:1
NDAs:2
Suppliers: see list3

Pharmacology for Tradename: RAPAMUNE

Clinical Trials for: RAPAMUNE

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: Active, not recruiting Condition: Tuberous Sclerosis Complex

Pharmacokinetic Drug Interaction Between Ezetimibe and Sirolimus After Single Dose Administration in Healthy Subjects
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression

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

Study of Everolimus Added to Combined Hormonal and Radiation Therapy for High Risk Prostate Cancer
Status: Terminated Condition: Prostate Cancer

STORM: Temsirolimus, Rituximab and DHAP for Relapsed and Refractory Diffuse Large B-cell Lymphoma
Status: Recruiting Condition: Diffuse Large B-Cell Lymphoma

Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab for the First-line Treatment in Adult Patients With Kidney Cancer
Status: Completed Condition: Carcinoma, Renal Cell; Adenocarcinoma, Renal Cell; Nephroid Carcinoma,; Hypernephroid

Phase Ib/II Trials of RAD001 in Triple Negative Metastatic Breast Cancer
Status: Recruiting Condition: Metastatic Breast Cancer

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
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Aug 22, 2002RXYes5,989,591*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083Sep 15, 1999RXYes5,100,899*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Jan 25, 2010RXNo5,989,591*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110Aug 25, 2000RXNo5,989,591*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083Sep 15, 1999RXYes5,536,729*PED<disabled>Y<disabled>
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Paragraph IV activity for: RAPAMUNE

Drugname Dosage Strength RLD Submissiondate
sirolimusTablets0.5 mgRapamune8/25/2010
sirolimusTablets1 mg and 2 mgRapamune12/17/2009
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Preferred citation:

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

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