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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Chubb
Queensland Health
Baxter
Fuji
McKinsey
Harvard Business School
Moodys

Generated: April 19, 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 two 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
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 N 0310-0668-60
LYNPARZA olaparib TABLET;ORAL 208558 NDA AstraZeneca Pharmaceuticals LP 0310-0668 N 0310-0668-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Aug 17, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 19, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Aug 17, 2020
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jan 12, 2021
Regulatory Exclusivity Use:TREATMENT OF DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE BRCA-MUTATED, HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2-NEGATIVE METASTATIC BREAST CANCER WHO HAVE BEEN TREATED WITH CHEMOTHERAPY IN THE NEOADJUVANT, ADJUVANT OR METASTATIC SETTING

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
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UBS
Cipla
Deloitte
Colorcon
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Federal Trade Commission
Chinese Patent Office

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