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Details for Generic Name: sirolimus

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Sirolimus is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Zydus Pharms Usa Inc, and Dr Reddys Labs Ltd, and is included in four NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for sirolimus. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sirolimus

Drug Master File Entries: see list16
Suppliers / Packaging: see list10

Pharmacology for Ingredient: sirolimus

Tentative approvals for SIROLIMUS

Applicant Application No. Form Dosage
<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 or Everolimus or Temsirolimus and Vorinostat in Advanced Cancer
Status: Recruiting Condition: Advanced Cancer

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

Efficacy of Sirolimus In Liver Transplantation for Hepatocellular Carcinoma (HCC)
Status: Active, not recruiting Condition: Hepatocellular Carcinoma

Pharmacokinectics of Sirolimus and Tacrolimus in Liver Transplant Recipients With Tacrolimus Toxicity
Status: Terminated Condition: Hypertension

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

Courtesy of
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
Dr Reddys Labs Ltd
TABLET;ORAL201578-002Oct 27, 2014RXNo<disabled><disabled>
Zydus Pharms Usa Inc
TABLET;ORAL201676-003Jan 8, 2014RXNo<disabled><disabled>
Pf Prism Cv
SOLUTION;ORAL021083-001Sep 15, 1999RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: sirolimus

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
TABLET;ORAL021110-002Aug 22, 20025,403,833*PED<disabled>
Pf Prism Cv
TABLET;ORAL021110-002Aug 22, 20025,308,847*PED<disabled>
Pf Prism Cv
TABLET;ORAL021110-003Feb 23, 20045,403,833*PED<disabled>
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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