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Olaparib - Generic Drug Details

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What are the generic drug sources for olaparib and what is the scope of patent protection?

Olaparib is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olaparib has two hundred and seventy-nine patent family members in fifty countries.

There are three drug master file entries for olaparib. One supplier is listed for this compound.

Summary for olaparib

International Patents:	279
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	118
Clinical Trials:	254
Patent Applications:	393
DailyMed Link:	olaparib at DailyMed

Recent Clinical Trials for olaparib

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

Sponsor	Phase
Ruijin Hospital	Phase 1/Phase 2
Florida Department of Health	Phase 2
Baptist Health South Florida	Phase 2

See all olaparib clinical trials

Pharmacology for olaparib

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

US Patents and Regulatory Information for olaparib

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
Astrazeneca Pharms	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		RX	Yes	Yes				Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes			Y	Y
Astrazeneca Pharms	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		RX	Yes	Yes
Astrazeneca Pharms	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		RX	Yes	Yes			Y	Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No

International Patents for olaparib

Country	Patent Number	Estimated Expiration
Lithuania	2346495
Canada	2664275
Norway	20091882
New Zealand	525138
South Korea	20060066067
South Africa	200600679
South Korea	20030059811

Supplementary Protection Certificates for olaparib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2346495	122018000124	Germany		PRODUCT NAME: AMORPHES OLAPARIB, ODER EIN SALZ ODER SOLVAT DAVON, IN EINER FESTEN DISPERSION; REGISTRATION NO/DATE: EU/1/14/959/002-005 20180508
2346495	2018C/042	Belgium		PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
1633724	PA2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	1590019-4	Sweden		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724	13/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	PA2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216