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Generated: January 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 211288

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NDA 211288 describes VIZIMPRO, which is a drug marketed by Pfizer Inc and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the VIZIMPRO profile page.

The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.
Summary for 211288
Tradename:VIZIMPRO
Applicant:Pfizer Inc
Ingredient:dacomitinib
Patents:2
Generic Entry Opportunity Date for 211288
Generic Entry Date for 211288*:
Constraining patent/regulatory exclusivity:
FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
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: 211288
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VIZIMPRO dacomitinib TABLET;ORAL 211288 NDA Pfizer Laboratories Div Pfizer Inc 0069-0197 0069-0197-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-0197-30)
VIZIMPRO dacomitinib TABLET;ORAL 211288 NDA Pfizer Laboratories Div Pfizer Inc 0069-1198 0069-1198-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0069-1198-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength15MG
Approval Date:Sep 27, 2018TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 27, 2025
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Sep 27, 2025
Regulatory Exclusivity Use:INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Regulatory Exclusivity Expiration:Sep 27, 2023
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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