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Serving leading biopharmaceutical companies globally:

McKesson
Healthtrust
Teva
Fuji
Daiichi Sankyo
Fish and Richardson
Moodys
Johnson and Johnson
Federal Trade Commission
Medtronic

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208065

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NDA 208065 describes TAGRISSO, which is a drug marketed by Astrazeneca Pharms and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the TAGRISSO profile page.

The generic ingredient in TAGRISSO is osimertinib mesylate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.
Summary for 208065
Tradename:TAGRISSO
Applicant:Astrazeneca Pharms
Ingredient:osimertinib mesylate
Patents:2
Suppliers and Packaging for NDA: 208065
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TAGRISSO osimertinib mesylate TABLET;ORAL 208065 NDA AstraZeneca Pharmaceuticals LP 0310-1349 0310-1349-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1349-30)
TAGRISSO osimertinib mesylate TABLET;ORAL 208065 NDA AstraZeneca Pharmaceuticals LP 0310-1350 0310-1350-30 30 TABLET, FILM COATED in 1 BOTTLE (0310-1350-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 40MG BASE
Approval Date:Nov 13, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Nov 13, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 13, 2022
Regulatory Exclusivity Use:ORPHAN DRUG EXCLUSIVITY
Patent:➤ SubscribePatent Expiration:Aug 8, 2032Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTORE RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

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Serving leading biopharmaceutical companies globally:

Covington
Citi
QuintilesIMS
US Department of Justice
Colorcon
Express Scripts
Dow
Farmers Insurance
Cipla

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