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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020571

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NDA 020571 describes CAMPTOSAR, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the CAMPTOSAR profile page.

The generic ingredient in CAMPTOSAR is irinotecan hydrochloride. There are thirty-three drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the irinotecan hydrochloride profile page.
Summary for 020571
Tradename:CAMPTOSAR
Applicant:Pfizer Inc
Ingredient:irinotecan hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 020571
Mechanism of ActionTopoisomerase Inhibitors
Suppliers and Packaging for NDA: 020571
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571 NDA Pharmacia and Upjohn Company LLC 0009-7529 0009-7529-03 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-7529-03) > 5 mL in 1 VIAL, SINGLE-DOSE
CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571 NDA Pharmacia and Upjohn Company LLC 0009-7529 0009-7529-04 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-7529-04) > 2 mL in 1 VIAL, SINGLE-DOSE
Paragraph IV (Patent) Challenges for 020571
Tradename Dosage Ingredient NDA Submissiondate
CAMPTOSAR INJECTABLE;INJECTION irinotecan hydrochloride 020571 2004-07-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/2ML (20MG/ML)
Approval Date:Jun 14, 1996TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 28, 2020Product Flag?Substance Flag?Delist Request?Y
Patent:  Start TrialPatent Expiration:Nov 1, 2020Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Jun 14, 1996TE:APRLD:Yes
Patent:  Start TrialPatent Expiration:Oct 28, 2020Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020571

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-001 Jun 14, 1996   Start Trial   Start Trial
Pfizer Inc CAMPTOSAR irinotecan hydrochloride INJECTABLE;INJECTION 020571-002 Jun 14, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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