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Generated: November 15, 2018

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Details for New Drug Application (NDA): 208447

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NDA 208447 describes ZEJULA, which is a drug marketed by Tesaro Inc 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 ZEJULA profile page.

The generic ingredient in ZEJULA is niraparib tosylate. One supplier is listed for this compound. Additional details are available on the niraparib tosylate profile page.
Summary for 208447
Tradename:ZEJULA
Applicant:Tesaro Inc
Ingredient:niraparib tosylate
Patents:2
Generic Entry Opportunity Date for 208447
Generic Entry Date for 208447*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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.

Pharmacology for NDA: 208447
Suppliers and Packaging for NDA: 208447
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEJULA niraparib tosylate CAPSULE;ORAL 208447 NDA TESARO, Inc. 69656-103 69656-103-30 30 CAPSULE in 1 BOTTLE (69656-103-30)
ZEJULA niraparib tosylate CAPSULE;ORAL 208447 NDA TESARO, Inc. 69656-103 69656-103-90 90 CAPSULE in 1 BOTTLE (69656-103-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrengthEQ 100MG BASE
Approval Date:Mar 27, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 27, 2024
Regulatory Exclusivity Use:INDICATED FOR MAINTENANCE TREATMENT OF ADULT PATIENTS WITH RECURRENT EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER WHO ARE IN A COMPLETE OR PARTIAL RESPONSE TO PLATINUM-BASED CHEMOTHERAPY
Regulatory Exclusivity Expiration:Mar 27, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Mar 22, 2030Product Flag?YSubstance Flag?YDelist Request?

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