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BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

Queensland Health
Dow
Mallinckrodt
Baxter
Merck
Colorcon
McKinsey
Healthtrust
Farmers Insurance
Cantor Fitzgerald

Generated: December 16, 2017

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 three 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-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the erlotinib hydrochloride profile page.

Summary for 021743

Tradename:1
Applicant:1
Ingredient:1
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 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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 25MG BASE
Approval Date:Nov 18, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 1, 2019
Regulatory Exclusivity Use:
Regulatory Exclusivity Expiration:Oct 18, 2019
Regulatory Exclusivity Use:
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 leading biopharmaceutical companies globally:

US Army
Medtronic
Cantor Fitzgerald
QuintilesIMS
Mallinckrodt
Johnson and Johnson
McKinsey
Healthtrust
Novartis
US Department of Justice

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.

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