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Sirolimus - Generic Drug Details

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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. Seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: sirolimus

Tradenames:2
Patents:1
Applicants:3
NDAs:4
Drug Master File Entries: see list16
Suppliers / Packaging: see list7
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: sirolimus

Tentative approvals for SIROLIMUS

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

Clinical Trials for: sirolimus

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;ORAL021110-004Jan 25, 2010RXNoMay 28, 2022
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004DISCNNo5,989,591*PEDSep 11, 2018Y
Dr Reddys Labs Ltd
SIROLIMUS
sirolimus
TABLET;ORAL201578-002Oct 27, 2014RXNo
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Expired Orange Book Patents for Generic Ingredient: sirolimus

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 20045,403,833*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 20005,403,833*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
SOLUTION;ORAL021083-001Sep 15, 19995,100,899*PED<disabled>
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