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Generated: October 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208558

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NDA 208558 describes LYNPARZA, which is a drug marketed by Astrazeneca Pharms and is included in two NDAs. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the LYNPARZA profile page.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the olaparib profile page.
Summary for 208558
Tradename:LYNPARZA
Applicant:Astrazeneca Pharms
Ingredient:olaparib
Patents:7
Generic Entry Opportunity Date for 208558
Generic Entry Date for 208558*:
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.

Pharmacology for NDA: 208558
Suppliers and Packaging for NDA: 208558
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYNPARZA olaparib TABLET;ORAL 208558 NDA AstraZeneca Pharmaceuticals LP 0310-0668 0310-0668-12 120 TABLET, FILM COATED in 1 BOTTLE (0310-0668-12)
LYNPARZA olaparib TABLET;ORAL 208558 NDA AstraZeneca Pharmaceuticals LP 0310-0668 0310-0668-60 60 TABLET, FILM COATED in 1 BOTTLE (0310-0668-60)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 17, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 17, 2024
Regulatory Exclusivity Use: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:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 17, 2020
Regulatory Exclusivity Use:NEW PRODUCT

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