Apalutamide Patent Expiration

Apalutamide is Used for treating various forms of prostate cancer, including non-metastatic and metastatic types, in combination with different therapies. It was first introduced by Janssen Biotech Inc in its drug Erleada on Feb 14, 2018. 2 different companies have introduced drugs containing Apalutamide.


Apalutamide Patents

Given below is the list of patents protecting Apalutamide, 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
Erleada US11723898 Androgen Receptor Inhibitors For The Treatment Of Non-Metastatic Castration-Resistant Prostate Cancer In Subjects With Severe Hepatic Impairment Jan 14, 2041 Janssen Biotech
Erleada US11963952 Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Jan 30, 2040 Janssen Biotech
Erleada US12303497 Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer Jan 30, 2040 Janssen Biotech
Erleada US10702508 Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer Apr 30, 2038 Janssen Biotech
Erleada US12303493 Anticancer compositions Dec 03, 2035 Janssen Biotech
Erleada US10052314 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Sep 23, 2033 Janssen Biotech
Erleada US10849888 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Sep 23, 2033 Janssen Biotech
Erleada US9884054 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Sep 23, 2033 Janssen Biotech
Erleada USRE49353 Anti-androgens for the treatment of non-metastatic castrate-resistant prostate cancer Sep 23, 2033 Janssen Biotech
Erleada USRE50642 Sep 23, 2033 Janssen Biotech
Erleada US9481663 Crystalline forms of an androgen receptor modulator Jun 04, 2033 Janssen Biotech
Erleada US8445507 Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases Feb 14, 2032 Janssen Biotech
Erleada US8802689 Androgen receptor modulator for the treatment of prostate cancer and androgen receptor-associated diseases Mar 27, 2027 Janssen Biotech
Erleada US9388159 Substituted diazaspiroalkanes as androgen receptor modulators Mar 27, 2027 Janssen Biotech
Erleada US9987261 Substituted diazaspiroalkanes as androgen receptor modulators Mar 27, 2027 Janssen Biotech



Apalutamide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Apalutamide:

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
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer H. Lee Moffitt Cancer Center and Research Institute NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Pembrolizumab Plus 177Lu-PSMA-617 in Patients With Castration Resistant Prostate Cancer University of California, San Francisco NA RECRUITING
(Sep 1, 2026)
PHASE2
A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC Novartis Pharmaceuticals NA ACTIVE NOT RECRUITING
(Sep 1, 2026)
PHASE2
Testing the Addition of Docetaxel (Chemotherapy) to the Usual Treatment (Hormonal Therapy and Apalutamide) for Metastatic Prostate Cancer, ASPIRE Trial Alliance for Clinical Trials in Oncology NA RECRUITING
(Sep 1, 2026)
PHASE3
Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancer Institute of Cancer Research, United Kingdom NA RECRUITING
(Sep 1, 2026)
PHASE1, PHASE2
Low Dose Naltrexone (LDN) for Management of Fatigue in Prostate Cancer Patients on Androgen Deprivation Therapy (ADT) University of Arkansas NA RECRUITING
(Sep 1, 2026)
PHASE2
Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer University College, London NA RECRUITING
(Sep 1, 2026)
PHASE3
A Study Testing if Patients With Advanced Prostate Cancer Who Are Responding Well to Combination Treatment Can Safely Reduce Their Medication to a Single Hormone Therapy, Compared to Continuing Their Current Drugs Kokilaben Dheerubhai Ambani Hospital and Research NA NOT YET RECRUITING
(Sep 1, 2026)
PHASE2
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS Aragon Pharmaceuticals, Inc. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1, PHASE2
A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE1
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Testing the Addition of the Drug Apalutamide to the Usual Hormone Therapy and Radiation Therapy After Surgery for Prostate Cancer, INNOVATE Trial NRG Oncology NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Apalutamide Combined With GnRH Agonist in Participants With Androgen Receptor Positive Salivary Gland Carcinoma Janssen Pharmaceutical K.K. NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial NRG Oncology NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer Janssen Pharmaceutica N.V., Belgium NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
The Effect of Metformin in Patients With Newly Diagnosed mHSPC Sun Yat-sen University NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM) Alliance for Clinical Trials in Oncology NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE2
A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC Janssen Research & Development, LLC NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer Janssen Research & Development, LLC NA RECRUITING
(Aug 1, 2026)
PHASE1
Prostate Cryoablation Combined With Metronomic Cyclophosphamide for Metastatic Prostate Cancer Sun Yat-sen University NA RECRUITING
(Aug 1, 2026)
PHASE2
Study of Oral MRT-2359 With Apalutamide in Prostate Cancer Monte Rosa Therapeutics, Inc NA RECRUITING
(Aug 1, 2026)
PHASE2
A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancer Astellas Pharma Global Development, Inc. NA NOT YET RECRUITING
(Aug 1, 2026)
PHASE1
ZEN-3694, Enzalutamide, and Pembrolizumab for the Treatment of Metastatic Castration-Resistant Prostate Cancer Rahul Aggarwal NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study of ORIC-944 in Patients With Metastatic Prostate Cancer ORIC Pharmaceuticals NA RECRUITING
(Jul 1, 2026)
PHASE1
Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial Jonsson Comprehensive Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE2
PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer. M.D. Anderson Cancer Center NA RECRUITING
(Jul 1, 2026)
PHASE3
Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE Trial Mayo Clinic NA RECRUITING
(Jul 1, 2026)
PHASE2
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging ECOG-ACRIN Cancer Research Group NA RECRUITING
(Jun 1, 2026)
PHASE3
The COSMYC Trial (COmbined Suppression of MYC) Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA RECRUITING
(Jun 1, 2026)
PHASE2
Phase III Randomized International Open Label Clinical Trial of Treatment Intensification With Docetaxel Plus Apalutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment With Apalutamide: REINFORCE Trial. Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD NA RECRUITING
(Jun 1, 2026)
PHASE3
RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Georgetown University NA NOT YET RECRUITING
(Jun 1, 2026)
PHASE2
Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy University of Wisconsin, Madison NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland National Cancer Institute (NCI) NA COMPLETED
(May 1, 2026)
PHASE2
Anti-tumour Activity of (177Lu) rhPSMA-10.1 Injection Blue Earth Therapeutics Ltd NA RECRUITING
(May 1, 2026)
PHASE1, PHASE2
A Study of Mevrometostat With Enzalutamide in People With Prostate Cancer Who Have Previously Received Androgen Receptor Pathway Inhibitor Therapy Prostate Cancer Clinical Trials Consortium NA NOT YET RECRUITING
(May 1, 2026)
PHASE2
Radiation Therapy With or Without Apalutamide in Treating Patients With Recurrent Prostate Cancer, the BALANCE Trial NRG Oncology NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Sir Mortimer B. Davis - Jewish General Hospital NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases Janssen Research & Development, LLC NA COMPLETED
(Apr 1, 2026)
PHASE2
Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer VA Office of Research and Development NA RECRUITING
(Apr 1, 2026)
PHASE2, PHASE3
Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer Weill Medical College of Cornell University NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
A Randomized Trial of Bicalutamide in Non-Muscle Invasive Bladder Cancer University of Wisconsin, Madison NA RECRUITING
(Apr 1, 2026)
PHASE1
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study University of Washington NA ACTIVE NOT RECRUITING
(Apr 1, 2026)
PHASE2
Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer Institut Paoli-Calmettes NA COMPLETED
(Mar 1, 2026)
PHASE2
Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy M.D. Anderson Cancer Center NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
Neoadjuvant High Dose Rate Brachytherapy Prior to Radical Prostatectomy in Patients With Prostate Cancer The Methodist Hospital Research Institute NA RECRUITING
(Mar 1, 2026)
PHASE1, PHASE2


Apalutamide Generic API Manufacturers

Only one generic application has been filed for Apalutamide.

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