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Darolutamide Patent Expiration

Darolutamide is Used for treating non-metastatic castration-resistant prostate cancer. It was first introduced by Bayer Healthcare Pharmaceuticals Inc in its drug Nubeqa on Jul 30, 2019.


Darolutamide Patents

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

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Country : United States (US)
Patent Category : All
Dosage Form Category : Others
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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Nubeqa US12329742 Pharmaceutical composition of darolutamide Jun 17, 2042 Bayer Healthcare
Nubeqa US12611397 Jul 02, 2040 Bayer Healthcare
Nubeqa US11168058 Manufacture of a crystalline pharmaceutical product Feb 27, 2038 Bayer Healthcare
Nubeqa US10010530 Carboxamide derivative and its diastereomers in stable crystalline form Jan 28, 2036 Bayer Healthcare
Nubeqa US10383853 Carboxamide derivative and its diastereomers in stable crystalline form Jan 28, 2036 Bayer Healthcare
Nubeqa US10835515 Carboxamide derivative and its diastereomers in stable crystalline form Jan 28, 2036 Bayer Healthcare
Nubeqa US8975254 Androgen receptor modulating compounds Mar 25, 2033 Bayer Healthcare
Nubeqa US10711013 Androgen receptor modulating compounds Oct 27, 2030 Bayer Healthcare
Nubeqa US11046713 Androgen receptor modulating compounds Oct 27, 2030 Bayer Healthcare
Nubeqa US9657003 Androgen receptor modulating compounds Oct 27, 2030 Bayer Healthcare



Darolutamide's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Darolutamide:

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
Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancer Astellas Pharma Global Development, Inc. NA RECRUITING
(Sep 1, 2026)
PHASE1
Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction Qilu Pharmaceutical Co., Ltd. NA RECRUITING
(Sep 1, 2026)
PHASE1
A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer. Bayer NA RECRUITING
(Aug 6, 2026)
PHASE2
Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial) Latin American Cooperative Oncology Group NA COMPLETED
(Aug 1, 2026)
PHASE2
A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study. Bayer NA COMPLETED
(Aug 1, 2026)
PHASE2
Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) Janux Therapeutics NA RECRUITING
(Aug 1, 2026)
PHASE1
A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients Jena University Hospital NA ACTIVE NOT RECRUITING
(Aug 1, 2026)
PHASE3
Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC Yonghong Li NA RECRUITING
(Aug 1, 2026)
PHASE2
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer Bayer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study ECOG-ACRIN Cancer Research Group NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies Bayer NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents AstraZeneca NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE3
Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jul 1, 2026)
PHASE2
Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse UNICANCER NA RECRUITING
(Jul 1, 2026)
PHASE3
Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05) AstraZeneca NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE3
Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate Cancer Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer. RenJi Hospital NA NOT YET RECRUITING
(Jul 1, 2026)
PHASE2
Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide Alliance Foundation Trials, LLC. NA COMPLETED
(Jun 1, 2026)
PHASE2
Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer Bayer NA COMPLETED
(Jun 1, 2026)
PHASE2
Testing the Anti-cancer Drug Darolutamide in Patients With Testosterone-Driven Salivary Gland Cancers National Cancer Institute (NCI) NA ACTIVE NOT RECRUITING
(Jun 1, 2026)
PHASE2
SNV1521 in Participants With Advanced Solid Tumors Synnovation Therapeutics, Inc. NA RECRUITING
(Jun 1, 2026)
PHASE1
Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer Icahn School of Medicine at Mount Sinai NA RECRUITING
(Jun 1, 2026)
PHASE2
Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer Amgen NA RECRUITING
(Jun 1, 2026)
PHASE1
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) Novartis Pharmaceuticals NA RECRUITING
(Jun 1, 2026)
PHASE1, PHASE2
Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate University of Sydney NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE3
SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer Institut Claudius Regaud NA ACTIVE NOT RECRUITING
(May 1, 2026)
PHASE2
A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC) Daiichi Sankyo NA RECRUITING
(May 1, 2026)
PHASE1
ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) UNICANCER NA RECRUITING
(Apr 1, 2026)
PHASE3
Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY) National Cancer Center Hospital East NA COMPLETED
(Apr 1, 2026)
PHASE2
Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer Celcuity Inc NA RECRUITING
(Apr 1, 2026)
PHASE1, PHASE2
Working Out M0 Bipolar Androgen Therapy Australian and New Zealand Urogenital and Prostate Cancer Trials Group NA RECRUITING
(Apr 1, 2026)
PHASE2
PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPC West China Hospital NA NOT YET RECRUITING
(Apr 1, 2026)
PHASE2
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED) Atish Choudhury, MD NA ACTIVE NOT RECRUITING
(Mar 1, 2026)
PHASE2
A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001) K36 Therapeutics, Inc. NA RECRUITING
(Mar 1, 2026)
PHASE1
Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins NA RECRUITING
(Mar 1, 2026)
PHASE2


Darolutamide Generic API Manufacturers

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


Darolutamide News

Bayer's Nubeqa gains FDA approval in the US for individuals with advanced prostate cancer.

05 Jun, 2025

Orion, a pharmaceutical company from Finland, looks to increase sales in the United States by promoting its successful prostate cancer medication.

26 Sep, 2024

Bayer, in collaboration with Orion, applies to U.S. FDA for third indication of ...

26 Sep, 2024

Bayer's Nubeqa, a Drug for Prostate Cancer, Expected to Achieve Significant Sales in 2024.

22 Mar, 2024

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