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Generated: November 16, 2018

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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
Generic Entry Opportunity Date for 208065
Generic Entry Date for 208065*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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, 2022
Regulatory Exclusivity Use:FOR TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), AS DETECTED BY AN FDA-APPROVED TEST, WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
Regulatory Exclusivity Expiration:Apr 18, 2025
Regulatory Exclusivity Use:INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Nov 13, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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