Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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:
MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY
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:Dec 19, 2021
Regulatory Exclusivity Use:FIRSTLINE MAINTENANCE TX IN PTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE, SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE OR PRIMARY PERITONEAL CA WHO ARE IN COMPLETE OR PARTIAL RESPONSE TO FIRSTLINE PLATINUM-BASED CHEMOTHERAPY
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, 2025
Regulatory Exclusivity Use:MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.