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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021110

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NDA 021110 describes RAPAMUNE, which 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. Additional details are available on the RAPAMUNE profile page.

The generic ingredient in RAPAMUNE is sirolimus. There are twenty-one drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 021110
Tradename:RAPAMUNE
Applicant:Pf Prism Cv
Ingredient:sirolimus
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 021110
Suppliers and Packaging for NDA: 021110
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAPAMUNE sirolimus TABLET;ORAL 021110 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1040 0008-1040-05 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1040-05)
RAPAMUNE sirolimus TABLET;ORAL 021110 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1040 0008-1040-10 100 BLISTER PACK in 1 CARTON (0008-1040-10) > 1 TABLET, SUGAR COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 25, 2000TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)
Patent:➤ Try a Free TrialPatent Expiration:Sep 11, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 22, 2002TE:ABRLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Expired US Patents for NDA 021110

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-003 Feb 23, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-004 Jan 25, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv RAPAMUNE sirolimus TABLET;ORAL 021110-002 Aug 22, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Julphar
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Covington
Dow
Daiichi Sankyo
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Deloitte
Farmers Insurance
McKinsey

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