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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 seventy-three patent family members in forty-nine 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:	273
US Patents:	8
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	113
Clinical Trials:	74
Patent Applications:	189
Drug Prices:	Drug price information for LYNPARZA
DailyMed Link:	LYNPARZA at DailyMed

Generic Entry Opportunity Date for LYNPARZA

NDA:

206162

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

MAINTENANCE TREATMENT OF ADULTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS GERMLINE OR SOMATIC BRCA-MUTATED ADVANCED EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER IN COMPLETE OR PARTIAL RESPONSE TO FIRST-LINE PLATINUM-BASED CHEMOTHERAPY

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

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

4-{[3-(4-cyclopropanecarbonylpiperazine-1-carbonyl)-4-fluorophenyl]methyl}-2H-phthalazin-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

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

BCP01872

BCP9000363

BCPP000360

BDBM27566

BR-40514

BRD-K02113016-001-08-9

BRD-K02113016-001-09-7

cc-16

CHEBI:83766

CHEMBL521686

CS-0075

CTK8B3857

D09730

DB09074

EN002690

EX-7210

EX-A002

FDLYAMZZIXQODN-UHFFFAOYSA-N

FT-0083489

FT-0651458

GP0126

GTPL7519

HMS3654G13

HY-10162

I06-2362

J-503540

KS-00000HXY

KU-0059436

KU-59436

KU0059436

KU59436

Lynparza (TN)

MFCD13185161

MFCD13185161 (95%)

MLS006010185

MolPort-009-679-395

NCGC00238451-01

NCGC00238451-02

NCGC00238451-09

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

Olaparibum

PubChem19148

QC-2660

RL04905

S-3781

S-7836

s1060

SB14617

SC-65060

SCHEMBL426568

SMR004701291

SS-4573

SW218142-2

SY040527

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

International Patents for LYNPARZA

Country	Patent Number	Estimated Expiration
Hungary	S1800043
Slovenia	1633724
Ukraine	97494
Canada	2423279
Spain	2359131

Supplementary Protection Certificates for LYNPARZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1633724	15C0022	France		PRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
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
1633724	13/2015	Austria		PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724	122015000025	Germany		PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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