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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

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

See drug prices for LYNPARZA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for LYNPARZA

NDA:

206162

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

FDA exclusivity

NDA:

208558

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

Sponsor	Phase
AGO Research GmbH	Phase 2
University of Michigan Rogel Cancer Center	Phase 2
University of North Carolina, Chapel Hill	Phase 1/Phase 2

See all LYNPARZA clinical trials

Pharmacology for LYNPARZA

Drug Class	Poly(ADP-Ribose) Polymerase Inhibitor
Mechanism of Action	Poly(ADP-Ribose) Polymerase Inhibitors

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
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No			Y	Y
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No

International Patents for LYNPARZA

Country	Patent Number	Estimated Expiration
Morocco	27758
Canada	2664275
Australia	2004220321
Saudi Arabia	2638

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	C20150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724	13/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	CR 2015 00012	Denmark		PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218