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RAPAMUNE Drug Profile

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Rapamune is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from two 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. Six 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 list2

Pharmacology for Tradename: RAPAMUNE

Clinical Trials for: RAPAMUNE

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, 2010RXNo5,989,591*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;ORAL021110-001Aug 25, 2000RXNo<disabled><disabled>
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Expired Patents for Tradename: RAPAMUNE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-001Aug 25, 20005,308,847*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-004Jan 25, 20105,212,155*PED<disabled>
Pf Prism Cv
RAPAMUNE
sirolimus
TABLET;ORAL021110-002Aug 22, 20025,212,155*PED<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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