Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
UBS
Fish and Richardson
Federal Trade Commission
Teva
Fuji
US Army
Dow
Cipla

Generated: November 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021743

« Back to Dashboard

NDA 021743 describes TARCEVA, which is a drug marketed by Osi Pharms and is included in one NDA. It is available from one supplier. 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. One supplier is 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
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 50242-062-01 30 TABLET in 1 BOTTLE (50242-062-01)
TARCEVA erlotinib hydrochloride TABLET;ORAL 021743 NDA Genentech, Inc. 50242-063 50242-063-01 30 TABLET in 1 BOTTLE (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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Julphar
UBS
Daiichi Sankyo
Moodys
Fuji
Teva
Harvard Business School
Citi

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.