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LYNPARZA Drug Profile

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Which patents cover Lynparza, and when can generic versions of Lynparza launch?

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

This drug has two hundred and sixty-five patent family members in forty-eight 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.

Summary for LYNPARZA

International Patents:	265
US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	101
Clinical Trials:	40
Patent Applications:	162
Drug Prices:	Drug price information for LYNPARZA
DailyMed Link:	LYNPARZA at DailyMed

Generic Entry Opportunity Date for LYNPARZA

NDA:

206162

Dosage:

CAPSULE;ORAL

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.

Pharmacology for LYNPARZA

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

Synonyms for LYNPARZA

(2H)-Phthalazinone, 4-((3-((4-(cyclopropylcarbonyl)-1-piperazinyl)carbonyl)-4-fluorophenyl)methyl)-

09L

1-(cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1

1-(Cyclopropylcarbonyl)-4-[5-[(3,4-dihydro-4-oxo-1-phthalazinyl)methyl]-2-fluorobenzoyl]piperazine

1(2H)-Phthalazinone, 4-[[3-[[4-(cyclopropylcarbonyl)-1-piperazinyl]carbonyl]-4-fluorophenyl]methyl]-

1021843-02-6

4-((3-{(4-(cyclopropylcarbonyl)piperazin-1-yl)carbonyl}-4-fluorophenyl)methyl)phthalazin-1(2H)-one

4-({3-[(4-cyclopropanecarbonylpiperazin-1-yl)carbonyl]-4-fluorophenyl}methyl)-1,2-dihydrophthalazin-1-one

4-(3-(4-(Cyclopropanecarbonyl)piperazine-1-carbonyl)-4-fluorobenzyl)phthalazin-1(2H)-one

4-(3-{[4-(Cyclopropylcarbonyl)piperazin-1-Yl]carbonyl}-4-Fluorobenzyl)phthalazin-1(2h)-One

4-[(3-{[4-(Cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorophenyl)methyl]phthalazin-1(2H)-one

4-[(3-{[4-Cyclopropylcarbonyl)piperazin-4-yl]carbonyl}-4-fluorophenyl)methyl]phtalazin-1(2H)-one

4-[[3-[4-(cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluoro-phenyl]methyl]-2H-phthalazin-1-one

4-[[3-[4-(Cyclopropanecarbonyl)piperazine-1-carbonyl]-4-fluorophenyl]methyl]-2H-phthalazin-1-one

4-[3-(4-Cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one

4-{[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorophenyl]methyl}-1,2-dihydrophthalazin-1-one

4CA-0938

763113-22-0

894104-70-2

937799-91-2

A9666

AB0009952

AB1009702

ABP000423

AC-7939

ACN-032229

Acylpiperazine analogue, 47

AJ-101717

AK-40514

AKOS005145764

AN-493

AN-5279

ANW-43329

AOB1085

API0024518

AX8162101

AZ2281

AZD 2281

AZD 2281|||KU 0059436|||KU 59436

AZD-2281

AZD-2281 (Olaparib)

AZD2281

AZD2281,Olaparib, KU-0059436

AZD2281(olaparib)

AZD2281(olaparib)/AZD-2281/KU0059436

BB 0260909

BC245405

BCP9000363

BCPP000360

BDBM27566

BR-40514

BRD-K02113016-001-08-9

BRD-K02113016-001-09-7

cc-16

CHEBI:83766

CHEMBL521686

CS-0075

CTK8B3857

D09730

D0J9HW

DB09074

EN002690

EX-7210

EX-A002

FDLYAMZZIXQODN-UHFFFAOYSA-N

FT-0083489

FT-0651458

GP0126

GTPL7519

HE068402

HE386863

HMS3654G13

HY-10162

I06-2362

J-503540

KS-00000HXY

KU-0059436

KU-59436

KU0059436

KU59436

Lynparza (TN)

MFCD13185161

MLS006010185

MolPort-009-679-395

NCGC00238451-01

NCGC00238451-02

NSC-747856

NSC747856

Olaparib

Olaparib - AZD2281

Olaparib (AZD2281, Ku-0059436)

Olaparib (AZD2281, KU0059436)

Olaparib (AZD2281)

Olaparib (JAN/USAN/INN)

Olaparib [USAN:INN]

OLAPARIB cpd

Olaparib, KU-0059436, AZD2281,KU0059436, AZD2281

Olaparibum

PubChem19148

QC-2660

RL04905

S-3781

S-7836

s1060

SC-65060

SCHEMBL426568

SMR004701291

SS-4573

UNII-WOH1JD9AR8

WOH1JD9AR8

Z-3275

ZINC40430143

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

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Non-Orange Book US Patents for LYNPARZA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,351,701	Therapeutic compounds
7,750,006	Phthalazinone derivatives
9,566,276	Phthalazinone derivatives
8,071,579	DNA damage repair inhibitors for the treatment of cancer
7,531,530	Therapeutic compounds
7,692,006	Phthalazinone derivatives
7,662,818	Phthalazinone derivatives

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International Patents for LYNPARZA

Country	Document Number	Estimated Expiration
Canada	2547077
European Patent Office	2374800
Japan	5848728
Denmark	1330442
Hong Kong	1084602
World Intellectual Property Organization (WIPO)	2005012524
Cyprus	1112345

Supplementary Protection Certificates for LYNPARZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/016	Ireland		PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2015016	Lithuania		PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
00726	Netherlands		PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2015016,C1633724	Lithuania		PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
0150012 00136	Estonia		PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014