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Last Updated: August 14, 2020

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LYNPARZA Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Lynparza

Lynparza was eligible for patent challenges on December 19, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 27, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LYNPARZA
Drug patent expirations by year for LYNPARZA
Drug Prices for LYNPARZA

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Generic Entry Opportunity Date for LYNPARZA
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for LYNPARZA*:
Constraining patent/regulatory exclusivity:
MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
NDA:
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.

Recent Clinical Trials for LYNPARZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Osteosarcoma InstitutePhase 2
Dana-Farber Cancer InstitutePhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2

See all LYNPARZA clinical trials

Pharmacology for LYNPARZA

US Patents and Regulatory Information for LYNPARZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LYNPARZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 596 Finland   Start Trial
2346495 300956 Netherlands   Start Trial PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515
1633724 PA2015016 Lithuania   Start Trial PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 C 2015 011 Romania   Start Trial PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
Express Scripts
McKesson
Mallinckrodt

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