Olaparib Patent Expiration

Olaparib is Used for treating various types of cancers, including breast, ovarian, pancreatic, and metastatic prostate cancer, in patients with specific gene mutations undergoing specific chemotherapy regimens. It was first introduced by Astrazeneca Pharmaceuticals Lp in its drug Lynparza on Dec 19, 2014.


Olaparib Patents

Given below is the list of patents protecting Olaparib, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Lynparza US11970530 Methods of treating homologous recombination deficient cancer Oct 25, 2041 Astrazeneca
Lynparza US8859562 Use of RNAI inhibiting PARP activity for the manufacture of a medicament for the treatment of cancer Aug 04, 2031 Astrazeneca
Lynparza US8475842 Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Dec 31, 2029 Astrazeneca
Lynparza US11633396 Immediate release pharmaceutical formulation of 4-[3-(4- cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H- phthalazin-1-one Oct 07, 2029 Astrazeneca
Lynparza US11975001 Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Oct 07, 2029 Astrazeneca
Lynparza US12048695 Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Oct 07, 2029 Astrazeneca
Lynparza US12144810 Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Oct 07, 2029 Astrazeneca
Lynparza US12178816 Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one Oct 07, 2029 Astrazeneca
Lynparza US8247416 Phthalazinone derivative Sep 24, 2028 Astrazeneca
Lynparza US7449464 Phthalazinone derivatives Sep 08, 2027 Astrazeneca
Lynparza US8071579 DNA damage repair inhibitors for the treatment of cancer Aug 12, 2027 Astrazeneca
Lynparza US8143241 DNA damage repair inhibitors for treatment of cancer Aug 12, 2027 Astrazeneca
Lynparza US7449464 Phthalazinone derivatives Oct 11, 2024

(Expired)

Astrazeneca
Lynparza US7981889 Phthalazinone derivatives Oct 11, 2024

(Expired)

Astrazeneca
Lynparza US8912187 Phthalazinone derivatives Mar 12, 2024

(Expired)

Astrazeneca
Lynparza US9169235 Phthalazinone derivatives Mar 12, 2024

(Expired)

Astrazeneca
Lynparza US9566276 Phthalazinone derivatives Mar 12, 2024

(Expired)

Astrazeneca
Lynparza US7151102 Phthalazinone derivatives Apr 29, 2022

(Expired)

Astrazeneca



Olaparib's Family Patents

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Clinical Trials

Recent Clinical Trials on Olaparib:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can... National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 17, 2026)
PHASE1, PHASE2
Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Olaparib With Cediranib or AZD6738 for the Treatment of Advanced or Metastatic Germline BRCA Mutated Breast Cancer M.D. Anderson Cancer Center NA RECRUITING
(Sep 1, 2026)
PHASE2
Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer National Cancer Institute (NCI) NA RECRUITING
(Sep 1, 2026)
PHASE1
Olaparib in Combination With Pembrolizumab for Advanced Uveal Melanoma H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Fusion Pharmaceuticals Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET) National Cancer Institute (NCI) NA RECRUITING
(Aug 14, 2026)
PHASE1, PHASE2
Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU) AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Study of DNA Damage, Angiogenesis, and PD-L1 Inhibitors in Advanced Solid Tumors University Health Network, Toronto NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Paclitaxel, Pembrolizumab and Olaparib in Previously Treated Advanced Gastric Adenocarcinoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA COMPLETED
(Aug 1, 2026)
PHASE2
Olaparib With Ceralasertib in Recurrent Osteosarcoma Dana-Farber Cancer Institute NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd Gustave Roussy, Cancer Campus, Grand Paris NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer Dana-Farber Cancer Institute NA RECRUITING
(Aug 1, 2026)
PHASE1
Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Olaparib in Treating Patients With Advanced Glioma, Cholangiocarcinoma, or Solid Tumors With IDH1 or IDH2 Mutations National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Durvalumab Treatment in Combination With Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib Treatment in Advanced Ovarian Cancer Patients AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Focal Radiation With Pulsed Systemic Therapy of Abiraterone, Androgen Deprivation Therapy (ADT), Lynparza Towards Castration Sensitive Oligometastatic Prostate Cancer (FAALCON) University of Michigan Rogel Cancer Center NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Pembrolizumab, Olaparib, and Temozolomide for People With Glioma Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
Olaparib in Subjects With Advanced Pancreatic Acinar Cell Carcinoma National Cancer Institute (NCI) NA TERMINATED
(Jul 1, 2026)
PHASE2
Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1
Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations Rana McKay, MD NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Pembro With Radiation With or Without Olaparib Zin W Myint NA RECRUITING
(Jul 1, 2026)
PHASE2
An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib University of Colorado, Denver NA RECRUITING
(Jul 1, 2026)
PHASE2
Cirtuvivint/Olaparib in Breast Cancer Susceptibility Gene/Homologous Recombination Deficiency Platinum Resistant Ovarian Cancer University of Colorado, Denver NA RECRUITING
(Jul 1, 2026)
PHASE1
A Study of BL-B01D1 Combination Therapy in Patients With Metastatic Castration-resistant Prostate Cancer Sichuan Baili Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2, PHASE3
A Study of Olaparib Prior to Surgery and Chemotherapy in Ovarian, Primary Peritoneal, and Fallopian Tube Cancer University Health Network, Toronto NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Study of Olaparib and Durvalumab in IDH-Mutated Solid Tumors University Health Network, Toronto NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007) Merck Sharp & Dohme LLC NA COMPLETED
(Jun 1, 2026)
PHASE2
Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib AstraZeneca NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE3
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 National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation National Cancer Institute (NCI) NA RECRUITING
(Jun 1, 2026)
PHASE2
Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined With the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed). Fundación de investigación HM NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Fluzoparib + Bevacizumab vs Olaparib + Bevacizumab for Maintenance Therapy in HRD-Positive Advanced Ovarian Cancer Shandong University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Does Cediranib Prevent Bowel Perforation in Platinum-resistant Ovarian Cancer Prof Gordon Jayson NA COMPLETED
(Jun 1, 2026)
PHASE2
Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects Northwestern University NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Pembrolizumab and Olaparib in Recurrent/Metastatic, Platinum Resistant Nasopharyngeal Cancer Gruppo Oncologico del Nord-Ovest NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers University of Colorado, Denver NA COMPLETED
(May 1, 2026)
PHASE2
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grade Ovarian Cancer Daewoong Pharmaceutical Co. LTD. NA RECRUITING
(May 1, 2026)
PHASE1
Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Selumetinib and Olaparib in Solid Tumors M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer University of Pennsylvania NA COMPLETED
(Apr 1, 2026)
PHASE2
Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors Rahul Aggarwal NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations Academic and Community Cancer Research United NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
177Lu-DOTA-TATE and Olaparib in Somatostatin Receptor Positive Tumours Vastra Gotaland Region NA COMPLETED
(Apr 1, 2026)
PHASE1
A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma Memorial Sloan Kettering Cancer Center NA COMPLETED
(Apr 1, 2026)
PHASE2
Study of LP-184 in Patients With Advanced Solid Tumors Lantern Pharma Inc. NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib) Medical College of Wisconsin NA COMPLETED
(Mar 1, 2026)
PHASE2
Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial) University of Michigan Rogel Cancer Center NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer. SOLTI Breast Cancer Research Group NA COMPLETED
(Mar 1, 2026)
PHASE2
QLS5132 Combination Therapy in Advanced Solid Tumors Qilu Pharmaceutical Co., Ltd. NA NOT YET RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Olaparib Generic API Manufacturers

Given below is the list of companies who have filed for Olaparib generic, along with the locations of their manufacturing plants worldwide.


Olaparib News

AstraZeneca and Merck introduce a new patent in their efforts to protect Lynparza from generic competition

21 Nov, 2024

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