Abiraterone Acetate Patent Expiration

Abiraterone Acetate is Used for the treatment of advanced prostate cancer in combination with prednisone, including metastatic castration-resistant and high-risk castration-sensitive types. It was first introduced by Janssen Biotech Inc in its drug Zytiga on Apr 28, 2011. Another drug containing Abiraterone Acetate is Yonsa. 15 different companies have introduced drugs containing Abiraterone Acetate.


Abiraterone Acetate Patents

Given below is the list of patents protecting Abiraterone Acetate, 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
Yonsa US10292990 Abiraterone steroid formulation May 20, 2034 Sun Pharm
Yonsa US9889144 Abiraterone acetate formulation and methods of use Mar 17, 2034 Sun Pharm
Zytiga US8822438 Methods and compositions for treating cancer Aug 24, 2027 Janssen Biotech
Zytiga US5604213 17-substituted steroids useful in cancer treatment Feb 18, 2014

(Expired)

Janssen Biotech



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Abiraterone Acetate's patents.

Given below is the list recent legal activities going on the following patents of Abiraterone Acetate.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 8th Year, Large Entity 13 Aug, 2025 US9889144
Payment of Maintenance Fee, 4th Year, Large Entity 21 Nov, 2022 US10292990
Payment of Maintenance Fee, 8th Year, Large Entity 16 Feb, 2022 US8822438
Payment of Maintenance Fee, 4th Year, Large Entity 13 Aug, 2021 US9889144
Review Certificate Mailed 21 Oct, 2019 US8822438
Review Certificate 11 Sep, 2019 US8822438
Recordation of Patent Grant Mailed 21 May, 2019 US10292990
Patent Issue Date Used in PTA Calculation 21 May, 2019 US10292990
Email Notification 02 May, 2019 US10292990
Issue Notification Mailed 01 May, 2019 US10292990


Abiraterone Acetate's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Abiraterone Acetate:

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
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study Astellas Pharma Global Development, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE3
M9466 Alone or in Combination in Advanced Solid Tumors (DDriver 501) EMD Serono Research & Development Institute, Inc. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1
A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Targeted Treatment for Metastatic Prostate Cancer, The PREDICT Trial Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Compare the Efficacy and Safety of BMS-986365 Versus the Investigator's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer Celgene NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) Merck Sharp & Dohme LLC NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study of Xaluritamig Plus Abiraterone Versus Investigator's Choice in Participants With Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer Amgen NA RECRUITING
(Sep 1, 2026)
PHASE3
Study of PSMA-targeted Therapy and Androgen Receptor Suppression in Low-volume Metastatic ProstatE Cancer: SPARKLE Trial Mayo Clinic NA RECRUITING
(Sep 1, 2026)
PHASE2
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1) ORIC Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE3
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Finite Androgen Ablation With or Without Abiraterone Acetate and Prednisone in Treating Patients With Recurrent Prostate Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for Treatment of Participants With Metastatic Prostate Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of AMG 509 in Participants With Metastatic Castration-Resistant Prostate Cancer Amgen NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Niraparib in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone for the Treatment of Participants With Deleterious Germline or Somatic Homologous Recombination Repair (HRR) Gene-MutatedProstatic Neoplasms (mCSPC) Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Comparative Formulations of Niraparib and Abiraterone Acetate (AA) in Men With Prostate Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer (China Cohort) AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer AstraZeneca NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE1
Study of HRS-5041 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study to Learn About the Investigational Medicine Called PF-06821497 (Mevrometostat) in Men With mCRPC Who Were Previously Treated With Abiraterone Acetate for Prostate Cancer (MEVPRO-1). Pfizer NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study to Learn How PF-06821497 (Mevrometostat) Works in Men With Metastatic Castration-resistant Prostate Cancer. Pfizer NA RECRUITING
(Aug 1, 2026)
PHASE3
Cabazitaxel +/- Carboplatin vs 177Lu-PSMA-617 in Metastatic Castrate-resistant Prostate Cancer Case Comprehensive Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide Prostate Cancer Clinical Trials Consortium NA RECRUITING
(Aug 1, 2026)
PHASE2
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer Astellas Pharma Global Development, Inc. NA RECRUITING
(Aug 1, 2026)
PHASE2
Study of Pembrolizumab (MK-3475) Combination Therapies in Metastatic Castration-Resistant Prostate Cancer (MK-3475-365/KEYNOTE-365) Merck Sharp & Dohme LLC NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery Rutgers, The State University of New Jersey NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Abiraterone Acetate and Antiandrogen Therapy With or Without Cabazitaxel and Prednisone in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer Previously Treated With Docetaxel ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Prostate Specific Membrane Antigen (PSMA) or (FACBC) PET/CT Site-Directed Therapy for Treatment of Prostate Cancer, Flu-BLAST-PC Study University of Washington NA RECRUITING
(Jul 1, 2026)
PHASE2
Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer OHSU Knight Cancer Institute NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer University of British Columbia NA RECRUITING
(Jul 1, 2026)
PHASE2
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE1, PHASE2
CJNJ-67652000 and Prednisone for Treatment of Metastatic Castration-Resistant Prostate Cancer and SPOP Gene Mutations Mayo Clinic NA TERMINATED
(Jul 1, 2026)
PHASE2
Study of XNW5004 Tablets in Advanced Prostate Cancer Evopoint Biosciences Inc. NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Pharmacogenomics IND Commercial SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2, PHASE3
Study of Pembrolizumab (MK-3475) Plus Enzalutamide Versus Placebo Plus Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-641/KEYNOTE-641) Merck Sharp & Dohme LLC NA COMPLETED
(Jun 1, 2026)
PHASE3
Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. Sun Pharmaceutical Industries Limited NA RECRUITING
(Jun 1, 2026)
PHASE2
A Study of Tinengotinib (TT-00420) in Combination With Standard Treatments in People With Prostate Cancer Memorial Sloan Kettering Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC Pathos AI, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
A Clinical Study of QLC5508 and/or QLH12016 in Combination With Other Anti-tumor Therapies in Subjects With Advanced Prostate Cancer Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Study of Abiraterone Acetate or Enzalutamide, Atezolizumab, GnRH Analog and Radiation Therapy in Men With Newly Diagnosed Hormone-sensitive Prostate Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
High-Risk Metachronous Oligometastatic Prostate Cancer Trial University of Maryland, Baltimore NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Neo-adjuvant Abiraterone Prostate Study Cancer Trials Ireland NA COMPLETED
(Apr 1, 2026)
PHASE2
Phase I Trial of Apalutamide Plus Abiraterone Acetate, Docetaxel, and Prednisone in Patients With mCRPC Weill Medical College of Cornell University NA COMPLETED
(Apr 1, 2026)
PHASE1
Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Abiraterone Acetate, Prednisone, and Apalutamide in Treating Patients With Hormone-Naive Metastatic Prostate Cancer M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Niraparib, Abiraterone Acetate and Prednisone for mHSPC With Deleterious Homologous Recombination Repair Alterations Qian Qin NA WITHDRAWN
(Apr 1, 2026)
PHASE2
STereotActic Body Radiotherapy and 177Lutetium PSMA in Locally Advanced Prostate Cancer Angela Y. Jia, MD PhD NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer M.D. Anderson Cancer Center NA TERMINATED
(Mar 1, 2026)
PHASE2
Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer University of California, Davis NA RECRUITING
(Mar 1, 2026)
PHASE2


Abiraterone Acetate Generic API Manufacturers

Several generic applications have been filed for Abiraterone Acetate. The first generic version for Abiraterone Acetate was by Apotex Inc and was approved on Oct 31, 2018. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Apr 24, 2024.

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