Details for New Drug Application (NDA): 208558

NDA 208558 describes LYNPARZA, which is a drug marketed by Astrazeneca and is included in two NDAs. It is available from one supplier. There are twelve patents protecting this drug. Additional details are available on the LYNPARZA profile page.

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 208558

Tradename:	LYNPARZA
Applicant:	Astrazeneca
Ingredient:	olaparib
Patents:	11

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 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 NDA: 208558

Mechanism of Action

Poly(ADP-Ribose) Polymerase Inhibitors

Suppliers and Packaging for NDA: 208558

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0569	0310-0569-12	120 TABLET, FILM COATED in 1 BOTTLE (0310-0569-12)
LYNPARZA	olaparib	TABLET;ORAL	208558	NDA	AstraZeneca Pharmaceuticals LP	0310-0569	0310-0569-60	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0569-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	100MG
Approval Date:	Aug 17, 2017	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	May 31, 2026
Regulatory Exclusivity Use:	IN COMBINATION WITH ABIRATERONE AND PREDNISONE OR PREDNISOLONE FOR THE TREATMENT OF ADULT PATIENTS WITH DELETERIOUS OR SUSPECTED DELETERIOUS BRCA-MUTATED (BRCAM) METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
Regulatory Exclusivity Expiration:	Dec 27, 2026
Regulatory Exclusivity Use:	MAINTENANCE TX OF ADULTS W/ DELETERIOUS OR SUSPECTED DELETERIOUS GBRCAM METASTATIC PANCREATIC ADENOCARCINOMA WHOSE DZ HAS NOT PROGRESSED ON >=16WKS OF 1ST LINE PLATINUM BASED CHEMO REGIMEN. SELECT PTS FOR THERAPY BASED ON APPROVED COMPANION DIAGNOSTIC
Regulatory Exclusivity Expiration:	May 8, 2027
Regulatory Exclusivity Use:	W/ BEVACIZUMAB FOR MAINT TX OF ADULTS W/ ADV EPITHELIAL OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CA IN COMPLETE OR PARTIAL RESPONSE TO 1ST LINE PT BASED CHEMO & WHOSE CA IS ASSOC W/ HOMOLOGOUS RECOMB DEF + STATUS DEFINED BY GENOMIC INSTABILITY

Expired US Patents for NDA 208558

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-002	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017
Astrazeneca	LYNPARZA	olaparib	TABLET;ORAL	208558-001	Aug 17, 2017

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