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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 eighteen 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 list18
Suppliers / Packagers: see list7
Bulk Api Vendors: see list43
Clinical Trials: see list193
Patent Applications: see list24,457
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sirolimus at DailyMed

Pharmacology for Ingredient: sirolimus

Tentative approvals for SIROLIMUS

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 2002RXYesYes5,989,591*PED► subscribeY► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 2000RXYesNo5,989,591*PED► subscribeY► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 2004DISCNYesNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: sirolimus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-003Feb 23, 20045,100,899*PED► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 20005,403,833*PED► subscribe
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 20025,145,684*PED► subscribe
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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 data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. 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.

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