drug
darolutamide
Marketedupdated 5mo agoby Bayer HealthCare Pharmaceuticals Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying darolutamide
- phase1Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction
- phase3AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)
- phase2Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer
- —An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
- phase2Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.
- phase2A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancer
- phase3A 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
- —A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Jun 3, 2028
~1.7 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (9)
- Jun 17, 2042formulationUS 12329742
- Feb 27, 2038compositionUS 11168058
- Jan 28, 2036compositionUS 10010530
- Jan 28, 2036compositionUS 10383853
- Jan 28, 2036formulationUS 10835515
- Mar 25, 2033compositionUS 8975254
- Oct 27, 2030compositionUS 107110134.1y
- Oct 27, 2030compositionUS 110467134.1y
- Oct 27, 2030compositionUS 96570034.1y
FDA exclusivities (1)
- Jun 3, 2028I-971Indication (3y)1.7y
News(2)
- Darolutamide Plus ADT Yields Significant OS Benefit in mHSPCDarolutamide plus ADT demonstrated a 50% reduction in the risk of death in metastatic hormone-sensitive prostate cancer.onclive · 4mo ago
- GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.onclive · 4mo ago
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