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Last Updated: January 21, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022088

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NDA 022088 describes TORISEL, which is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TORISEL profile page.

The generic ingredient in TORISEL is temsirolimus. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the temsirolimus profile page.
Summary for 022088
Applicant:Pf Prism Cv
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 022088
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TORISEL temsirolimus SOLUTION;INTRAVENOUS 022088 NDA Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. 0008-1179 0008-1179-01 1 KIT in 1 CARTON (0008-1179-01) * 1.8 mL in 1 VIAL, SINGLE-USE (0008-1125-01) * 25 mL in 1 VIAL, SINGLE-USE (0008-1279-01)
Paragraph IV (Patent) Challenges for 022088
Tradename Dosage Ingredient NDA Submissiondate
TORISEL SOLUTION;INTRAVENOUS temsirolimus 022088 2011-05-25

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;INTRAVENOUSStrength25MG/ML (25MG/ML)
Approval Date:May 30, 2007TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Aug 15, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jul 20, 2026Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Jan 25, 2024Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

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