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Chinese Patent Office
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Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021743

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NDA 021743 describes TARCEVA, which is a drug marketed by Osi Pharms and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TARCEVA profile page.

The generic ingredient in TARCEVA is erlotinib hydrochloride. There are twenty-five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.
Summary for 021743
Tradename:TARCEVA
Applicant:Osi Pharms
Ingredient:erlotinib hydrochloride
Patents:4
Therapeutic Class:Antineoplastics
Formulation / Manufacturing:see details
Pharmacology for NDA: 021743
Mechanism of ActionProtein Kinase Inhibitors
Medical Subject Heading (MeSH) Categories for 021743
Suppliers and Packaging for NDA: 021743
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TARCEVA erlotinib hydrochloride TABLET;ORAL 021743 NDA Genentech, Inc. 50242-062 N 50242-062-01
TARCEVA erlotinib hydrochloride TABLET;ORAL 021743 NDA Genentech, Inc. 50242-063 N 50242-063-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 18, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 18, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE CLINICAL STUDIES SECTION OF THE LABELING REGARDING THE LACK OF EFFICACY OF TARCEVA IN MAINTENANCE TREATMENT OF PATIENTS WITHOUT EGFR MUTATIONS
Regulatory Exclusivity Expiration:Jun 1, 2019
Regulatory Exclusivity Use:UPDATE TO THE DOSAGE AND ADMINISTRATION, PATIENT SELECTION (2.1), SECTION OF THE PACKAGE INSERT TO INCLUDE THE USE OF AN FDA-APPROVED PLASMA TEST FOR THE IDENTIFICATION OF EGFR EXON 19 DELETION OR EXON 21 (L858R) SUBSTITUTION MUTATIONS
Regulatory Exclusivity Expiration:May 20, 2019
Regulatory Exclusivity Use:UPDATES TO THE DOSAGE AND ADMINISTRATION, DOSE MODIFICATIONS SECTION OF THE LABELING

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
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