Viewing data from:

LYNPARZA

NDA

OLAPARIB | N206162 | ASTRAZENECA PHARMACEUTICALS LP

1 strength3 unique patents0 unique exclusivities

Patent Timeline

3 unique patents by expiration date

Active (3)Today

2027

2028

2029

2030

2031

Today

8143241

Aug. 12, 2027

8247416

Sep. 24, 2028

8859562

Aug. 4, 2031

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Zydus Pharmaceuticals (USA) Inc FDA-2016-P-3482 Zydus Pharmaceuticals (USA) Inc. filed this petition under section 505(j) of the FDC Act requesting that the FDA designate LYNPARZA (Olaparib capsules, 50 mg, NDA N206162) as a Reference Listed Drug to enable the filing of an abbreviated new drug application for a generic version of the product.	Other	2016-10-21	Withdrawn	Zydus Pharmaceuticals (USA) Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

16 trials from ClinicalTrials.gov — 7 recruiting, 7 active, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer NCT03598257	Phase 2	Active	National Cancer Institute (NCI)	300	2019-01-18 → 2027-06-01
First Line Treatment With Olaparib in Combination With Bevacizumab in HRD Positive Patients NCT06121401	Phase 4	Active	Mario Negri Institute for Pharmacological Research	190	2023-09-15 → 2027-09-15
Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma NCT05524935	Phase 2	Active	H. Lee Moffitt Cancer Center and Research Institute	12	2022-10-11 → 2027-12
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer NCT02489006	Phase 2	Active	University Health Network, Toronto	71	2016-07-19 → 2027-12-31
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.NCT03330847	Phase 2	Active	AstraZeneca	273	2018-03-07 → 2026-10-09
Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors NCT03991832	Phase 2	Active	University Health Network, Toronto	58	2019-12-31 → 2026-09-30
Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations NCT04548752	Phase 2	Active	National Cancer Institute (NCI)	88	2021-02-22 → 2026-10-01
PROLONG (PRostateOLaparibONcombinationGcc) Study NCT07674121	—	Not Yet Recruiting	AstraZeneca	75	2026-06-30 → 2029-09-30
NIS to Examine the Effectiveness and Safety of Durvalumab and Olaparib in Patients With Endometrial Cancer (DUOLife)NCT06890273	—	Recruiting	AstraZeneca	150	2025-05-20 → 2029-03-31
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)NCT06401980	Phase 2	Recruiting	Swiss Cancer Institute	162	2024-10-22 → 2030-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Lynparza (2023)

Total Spending

$487.4M

Total Claims

34,461

Beneficiaries

5,974

Avg Cost/Unit

$136.01

Spending Trend

$242.8M(2019)→$358.9M(2020)→$426.6M(2021)→$460.7M(2022)→$487.4M(2023)

YoY Change:+6.9%

5yr CAGR:+3.2%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain22 active DMFs

21 active API suppliers hold Drug Master Files for this ingredient.

ALP PHARM BEIJING CO LTDOLAPARIB

DMF 312192016

ALEMBIC PHARMACEUTICALS LTDOLAPARIB

DMF 325052018

SCINOPHARM TAIWAN LTDOLAPARIB

DMF 326292018

MSN LABORATORIES PRIVATE LTDOLAPARIB

DMF 346982020

DR REDDYS LABORATORIES LTDOLAPARIB

DMF 357422021

HETERO LABS LTDOLAPARIB

DMF 358312021

CIPLA LTDOLAPARIB

DMF 372402022

OLON SPAOLAPARIB FORM A

DMF 377792023

WISDOM PHARMACEUTICAL CO LTDOLAPARIB

DMF 381362023

SHANDONG ANHONG PHARMACEUTICAL CO LTDOLAPARIB

DMF 383952023

ALIVUS LIFE SCIENCES LTDOLAPARIB

DMF 389572023

CAMBREX PROFARMACO MILANO SRLOLAPARIB

DMF 395242024

HUADONG MEDICINE (XI'AN) BODYGUARD PHARMACEUTICAL CO LTDOLAPARIB MONOHYDRATE

DMF 404622024

BIOPHORE INDIA PHARMACEUTICALS PVT LTDOLAPARIB

DMF 404672024

SICHUAN KELUN PHARMACEUTICAL CO LTDOLAPARIB

DMF 406792024

BIOCON LTDOLAPARIB

DMF 413442025

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDOLAPARIB

DMF 418452025

CDYMAX (INDIA) PHARMA PRIVATE LTDOLAPARIB (FORM-H)

DMF 421432025

SCINOPHARM TAIWAN LTDOLAPARIB (FORM A)

DMF 423402025

INTAS PHARMACEUTICALS LTDOLAPARIB

DMF 423592025

BDR LIFESCIENCES PRIVATE LTDOLAPARIB

DMF 425272025

HUADONG MEDICINE (XI'AN) BODYGUARD BIOPHARMACEUTICAL CO LTDOLAPARIB

DMF 425962025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Oct 1, 2018	SUPPL -11	View Letter (PDF)
Oct 30, 2017	SUPPL -8	View Letter (PDF)
Aug 21, 2017	SUPPL -7	View Letter (PDF)
Jan 30, 2017	SUPPL -3	View Letter (PDF)
Oct 20, 2016	SUPPL -2	View Letter (PDF)
Dec 19, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLD

3 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Dec 19, 2014

Patents (3)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8143241	Aug 12, 2027	—	—	—		—
8247416	Sep 24, 2028	—	Yes	—	—	—
8859562	Aug 4, 2031	—	—	—		—