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Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206162

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NDA 206162 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 206162
Tradename:LYNPARZA
Applicant:Astrazeneca Pharms
Ingredient:olaparib
Patents:7
Generic Entry Opportunity Date for 206162
Generic Entry Date for 206162*:
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: 206162
Suppliers and Packaging for NDA: 206162
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYNPARZA olaparib CAPSULE;ORAL 206162 NDA AstraZeneca Pharmaceuticals LP 0310-0657 0310-0657-58 112 CAPSULE in 1 BOTTLE (0310-0657-58)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 19, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 19, 2021
Regulatory Exclusivity Use:USE OF AS MONOTHERAPY FOR PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA MUTATED (AS DETECTED BY AN FDA-APPROVED TEST) ADVANCED OVARIAN CANCER WHO HAVE BEEN TREATED WITH THREE OR MORE PRIOR LINES OF CHEMOTHERAPY
Patent:➤ Sign UpPatent Expiration:Apr 29, 2022Product Flag?YSubstance Flag?YDelist Request?

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