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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 eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olaparib has two hundred and eighty 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:	280
US Patents:	11
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	3
Suppliers / Packagers:	1
Bulk Api Vendors:	121
Clinical Trials:	285
Patent Applications:	1,421
What excipients (inactive ingredients) are in olaparib?	olaparib excipients list
DailyMed Link:	olaparib at DailyMed

Recent Clinical Trials for olaparib

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

Sponsor	Phase
AGO Research GmbH	Phase 2
North Eastern German Society of Gynaecological Oncology	Phase 2
Arbeitsgemeinschaft Gynaekologische Onkologie Austria	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			Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017		RX	Yes	No			Y	Y
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca Pharms	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017		RX	Yes	Yes
Astrazeneca Pharms	LYNPARZA	olaparib	CAPSULE;ORAL	206162-001	Dec 19, 2014		DISCN	Yes	No

International Patents for olaparib

Country	Patent Number	Estimated Expiration
Poland	1660095
Ukraine	97494
Costa Rica	20110186
Japan	5607773
Cyprus	1110335
Norway	341963
Norway	20063078

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
1633724	2015/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	C300726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	S1500012	Hungary		PRODUCT NAME: OLAPARIB
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724	C 2015 011	Romania		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
2346495	CA 2018 00039	Denmark		PRODUCT NAME: AMORF OLAPARIB ELLER ET SALT ELLER SOLVAT DERAF, I EN FAST DISPERSION; REG. NO/DATE: EU/1/14/959 20180515