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Last Updated: May 11, 2021

DrugPatentWatch Database Preview

LYNPARZA Drug Profile

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Which patents cover Lynparza, and what generic alternatives are available?

Lynparza is a drug marketed by Astrazeneca and is included in two NDAs. There are eleven patents protecting this drug.

This drug has two hundred and eighty patent family members in fifty countries.

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.

DrugPatentWatch® 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 May 8, 2027. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for LYNPARZA
International Patents:280
US Patents:11
Applicants:1
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 121
Clinical Trials: 100
Patent Applications: 743
Drug Prices: Drug price information for LYNPARZA
What excipients (inactive ingredients) are in LYNPARZA?LYNPARZA excipients list
DailyMed Link:LYNPARZA at DailyMed
Drug patent expirations by year for LYNPARZA
Drug Prices for LYNPARZA

See drug prices for LYNPARZA

DrugPatentWatch® Estimated 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:
FDA exclusivity
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
AGO Research GmbHPhase 2
University of Michigan Rogel Cancer CenterPhase 2
University of North Carolina, Chapel HillPhase 1/Phase 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 LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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 C20150012 00136 Estonia   Get Started for $10 PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724 13/2015 Austria   Get Started for $10 PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 CR 2015 00012 Denmark   Get Started for $10 PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724 1590019-4 Sweden   Get Started for $10 PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Dow
McKinsey
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McKesson
Mallinckrodt

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