Enzalutamide Patent Expiration

Enzalutamide is Used for treating non-metastatic castration-sensitive prostate cancer patients with biochemical recurrence at high risk for metastasis. It was first introduced by Astellas Pharma Us Inc in its drug Xtandi on Aug 31, 2012. 5 different companies have introduced drugs containing Enzalutamide.


Enzalutamide Patents

Given below is the list of patents protecting Enzalutamide, 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
Xtandi US12161628 Combination therapy Feb 23, 2037 Astellas
Xtandi US11839689 Formulations of enzalutamide Sep 11, 2033 Astellas
Xtandi US12447128 Formulations Of Enzalutamide Sep 11, 2033 Astellas
Xtandi US12502357 Formulations Of Enzalutamide Sep 11, 2033 Astellas
Xtandi US7709517 Diarylhydantoin compounds Aug 13, 2027 Astellas
Xtandi US8183274 Treatment of hyperproliferative disorders with diarylhydantoin compounds Aug 24, 2026

(Expired)

Astellas
Xtandi US9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds May 15, 2026

(Expired)

Astellas



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 Enzalutamide's patents.

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

Activity Date Patent Number
Patent litigations
Email Notification 19 Mar, 2025 US7709517(Litigated)
Change in Power of Attorney (May Include Associate POA) 19 Mar, 2025 US7709517(Litigated)
Change in Power of Attorney (May Include Associate POA) 17 Mar, 2025 US9126941(Litigated)
Email Notification 17 Mar, 2025 US9126941(Litigated)
Change in Power of Attorney (May Include Associate POA) 04 Mar, 2025 US8183274(Litigated)
Email Notification 04 Mar, 2025 US8183274(Litigated)
Email Notification 12 Dec, 2023 US11839689
Mail Patent eGrant Notification 12 Dec, 2023 US11839689
Recordation of Patent eGrant 12 Dec, 2023 US11839689
Recordation of Patent Grant Mailed 12 Dec, 2023 US11839689


Enzalutamide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Enzalutamide:

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
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC Pfizer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
An Efficacy and Safety Study of Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Chinese Patients With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Astellas (Beijing) Pharmaceutical R&D Co., Ltd. NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
Study of Talazoparib With Enzalutamide in Men With DDR Gene Mutated mCSPC Pfizer NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE3
FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer Rahul Aggarwal NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Enzalutamide and PDS01ADC in PET Positive Recurrent Prostate Cancer (pprPC) Without Testosterone Lowering Therapy National Cancer Institute (NCI) NA RECRUITING
(Sep 1, 2026)
PHASE2
An Open-label Study of JSB462 (Luxdegalutamide) in Combination With Abiraterone in Adult Male Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. Pfizer NA RECRUITING
(Sep 1, 2026)
PHASE3
A Phase Ib/II Open-label Study of AMO959 With Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI in Adult Participants With PSMA-positive mCRPC Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
A Study to Investigate the Safety and Tolerability of Oral INR731 Single Agent or in Combination With Androgen Receptor Pathway Inhibitor (ARPI) in Patients With Metastatic Prostate Cancer Novartis Pharmaceuticals NA RECRUITING
(Sep 1, 2026)
PHASE1
Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer University of Colorado, Denver NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of Patient Preference Between ODM-201 and Enzalutamide in Men With Metastatic Castrate-resistant Prostate Cancer Gustave Roussy, Cancer Campus, Grand Paris NA COMPLETED
(Aug 1, 2026)
PHASE2
A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma Pfizer NA RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Tulmimetostat DZR123 (CPI-0209) in Patients With Advanced Solid Tumors and Lymphomas Novartis Pharmaceuticals NA RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Pfizer NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991)-China Extension Merck Sharp & Dohme LLC NA COMPLETED
(Aug 1, 2026)
PHASE3
177Lu-PSMA-I&T for Metastatic Castration-Resistant Prostate Cancer Curium US LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Enzalutamide Plus the Glucocorticoid Receptor Antagonist Relacorilant Versus Placebo for Patients With High-risk Localized Prostate Cancer University of Chicago NA RECRUITING
(Aug 1, 2026)
PHASE2
Enzalutamide Implants (Enolen) in Patients With Prostate Cancer Alessa Therapeutics Inc. NA RECRUITING
(Aug 1, 2026)
PHASE1
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembrolizumab, or Enzalutamide for Metastatic TRPV6-overexpressing Solid Tumors of Epithelial Origin M.D. Anderson Cancer Center NA RECRUITING
(Aug 1, 2026)
PHASE1
Best Salvage Treatment for High-risk Relapsing Prostate Cancer (PEACE-9 - ESCALATE-RT) Ente Ospedaliero Cantonale, Bellinzona NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Norroy Bioscience Co., LTD NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) GlaxoSmithKline NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE3
Safety and Efficacy Study of Enzalutamide Plus Leuprolide in Patients With Nonmetastatic Prostate Cancer (EMBARK) Pfizer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Sequential Testosterone and Enzalutamide Prevents Unfavorable Progression Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA RECRUITING
(Jul 1, 2026)
PHASE2
Safety and Efficacy of Therapies for Metastatic Castration-resistant Prostate Cancer (mCRPC) Amgen NA TERMINATED
(Jul 1, 2026)
PHASE1, PHASE2
An Extension Study in Participants Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study (IMbrella C) Hoffmann-La Roche NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic NA RECRUITING
(Jul 1, 2026)
PHASE2
Feasibility Study of Adjuvant Enzalutamide for the Treatment of Early Stage AR (+) Triple Negative Breast Cancer Memorial Sloan Kettering Cancer Center NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
Presurgical Phase II Study of Talazoparib in Combination With Enzalutamide in Prostate Cancer M.D. Anderson Cancer Center NA RECRUITING
(Jun 1, 2026)
PHASE2
Safety, Tolerability, and Efficacy of CP-PCA07 in Combination With Enzalutamide in Patients With Castration-Resistant Prostate Cancer Hyundai Bioscience Co., Ltd. NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE1
Neoadjuvant Androgen Deprivation Therapy Combined With Enzalutamide and Abiraterone Using Multiparametric MRI and 18FDCFPyL PET/CT in Newly Diagnosed Prostate Cancer National Cancer Institute (NCI) NA COMPLETED
(May 20, 2026)
PHASE2
Tivozanib + Enzalutamide in Adv Prostate Cancer Massachusetts General Hospital NA TERMINATED
(May 1, 2026)
PHASE2
Enzalutamide in Androgen Deprivation Therapy With Radiation Therapy for High Risk, Clinically Localised, Prostate Cancer University of Sydney NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
Enzalutamide and Niclosamide in Treating Patients With Recurrent or Metastatic Castration-Resistant Prostate Cancer University of California, Davis NA COMPLETED
(May 1, 2026)
PHASE1
Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer University of Southern California NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Continuation Protocol for ZEN003694 in Patients Experiencing Clinical Benefit While Enrolled in a ZEN003694 Protocol Zenith Epigenetics NA ENROLLING BY INVITATION
(May 1, 2026)
PHASE1, PHASE2
ZEN003694 and Enzalutamide Versus Enzalutamide Monotherapy in Metastatic Castration-Resistant Prostate Cancer Zenith Epigenetics NA RECRUITING
(May 1, 2026)
PHASE2
Study of 177Lu-PSMA-617 In Metastatic Castrate-Resistant Prostate Cancer in Japan Novartis Pharmaceuticals NA COMPLETED
(May 1, 2026)
PHASE2
Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer Mayo Clinic NA COMPLETED
(May 1, 2026)
PHASE2
Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer Syntrix Biosystems, Inc. NA RECRUITING
(May 1, 2026)
PHASE2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial Sean Sachdev NA RECRUITING
(May 1, 2026)
PHASE2
A Phase III Clinical Study of Rezvilutamide in Patients With Metastatic Hormone-Sensitive Prostate Cancer Jiangsu HengRui Medicine Co., Ltd. NA RECRUITING
(May 1, 2026)
PHASE3
Radium-223 in Combination With Enzalutamide Cancer Trials Ireland NA COMPLETED
(Apr 1, 2026)
PHASE2
Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide OHSU Knight Cancer Institute NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Study to Evaluate Exicorilant (CORT125281) in Combination With Enzalutamide in Patients With Metastatic Castration-Resistant Prostate Cancer Corcept Therapeutics NA TERMINATED
(Apr 1, 2026)
PHASE1, PHASE2
Denosumab in Combination With Enzalutamide in Progressive Metastatic Castrate-resistant Prostate Cancer and Bone Metastases. Cancer Trials Ireland NA TERMINATED
(Apr 1, 2026)
PHASE2
Efficacy and Safety of Pembrolizumab (MK-3475) Plus Enzalutamide Plus Androgen Deprivation Therapy (ADT) Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (MK-3475-991/KEYNOTE-991) Merck Sharp & Dohme LLC NA COMPLETED
(Apr 1, 2026)
PHASE3
Study of 225Ac-PSMA-617 in Men With PSMA-positive Prostate Cancer Endocyte NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE1
Study Evaluating Zenocutuzumab in Patients With or Without Molecularly Defined Cancers Partner Therapeutics, Inc. NA TERMINATED
(Apr 1, 2026)
PHASE2
Castrate Resistant Prostate Cancer Enhertu Therapy Washington D.C. Veterans Affairs Medical Center NA RECRUITING
(Apr 1, 2026)
PHASE2
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer University of Michigan Rogel Cancer Center NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Enzalutamide With Ribociclib in Treating Patients With Metastatic Castrate-Resistant, Chemotherapy Naive Prostate Cancer That Retains Retinoblastoma Expression Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University NA TERMINATED
(Mar 1, 2026)
PHASE1, PHASE2
YS247 (Neoantigen-Pulsed DC Vaccine) for Metastatic Prostate Cancer Changhai Hospital NA ENROLLING BY INVITATION
(Mar 1, 2026)
PHASE1


Enzalutamide Generic API Manufacturers

Several generic applications have been filed for Enzalutamide. The first generic version for Enzalutamide was by Actavis Laboratories Fl Inc and was approved on May 14, 2021. And the latest generic version is by Sandoz Inc and was approved on Apr 20, 2026.

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


Enzalutamide News

Could the Exercise of March-in Rights Reduce Prices for Biologics? | Goodwin - JDSupra

12 Sep, 2025

ANDA Litigation Settlement Updates for Q2 2025 | Robins Kaplan LLP - JDSupra

13 Aug, 2025

Application for approval and permission to utilize federal rights in three patents for ...

13 Jun, 2025

Astellas takes legal action to protect patent of cancer medication from generic drug makers in the UK

14 Oct, 2024

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