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Serving hundreds of leading biopharmaceutical companies globally:

Dow
US Army
Boehringer Ingelheim
Argus Health
Baxter
Merck
Federal Trade Commission
Daiichi Sankyo
US Department of Justice

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021083

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NDA 021083 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 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 021083
Tradename:RAPAMUNE
Applicant:Pf Prism Cv
Ingredient:sirolimus
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021083
Suppliers and Packaging for NDA: 021083
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAPAMUNE sirolimus SOLUTION;ORAL 021083 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1030 N 0008-1030-06

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength1MG/ML
Approval Date:Sep 15, 1999TE:RLD:Yes
Regulatory Exclusivity Expiration:May 28, 2022
Regulatory Exclusivity Use:TREATMENTOF LYMPHANGIOLEIOMYOMATOSIS (LAM)

Expired US Patents for NDA 021083

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Sign Up ➤ Sign Up
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Sign Up ➤ Sign Up
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Sign Up ➤ Sign Up
Pf Prism Cv RAPAMUNE sirolimus SOLUTION;ORAL 021083-001 Sep 15, 1999 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Merck
UBS
Julphar
Baxter
Fish and Richardson
Federal Trade Commission
Fuji
Cantor Fitzgerald

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