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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 is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in RAPAMUNE is sirolimus. There are sixteen 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:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list10

Pharmacology for Tradename: RAPAMUNE

Clinical Trials for: RAPAMUNE

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

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

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

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

Bevacizumab, Temsirolimus, Valproic Acid, Cetuximab
Status: Recruiting Condition: Advanced Cancers

Phase I/Ib Dose Escalation & Biomarker Study of Ceritinib (LDK378) + Everolimus for Locally Advanced or Metastatic Solid Tumors With an Expansion in Non-Small Cell Lung Cancer (NSCLC) Characterized by Abnormalities in Anaplastic Lymphoma Kinase (ALK) Expression
Status: Not yet recruiting Condition: Head and Neck Cancer; Lung Cancer

Trial to Evaluate Paclitaxel Plus RAD001 in Urothelial Carcinoma
Status: Terminated Condition: Bladder Cancer

Prospective Study of Rapamycin for the Treatment of SLE
Status: Active, not recruiting Condition: Systemic Lupus Erythematosus (SLE)

Phase I/II Study of Irinotecan and Temsirolimus in Patients With Refractory Sarcomas
Status: Terminated Condition: Sarcoma

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
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 1999RXYes<disabled><disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002RXYes<disabled><disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000RXNo5,989,591*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004DISCNNo5,989,591*PED<disabled>Y<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 2010RXNo5,989,591*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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