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Darolutamide
CAS NO.: 1297538-32-9
Chemical Formula: C19H19ClN6O2
Molecular Weight: 398.8000
DMF&GMP status: Please contact us for more details.
Description:
Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment. The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer. Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.

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Approvals
Active Ingredient Dosage Form; Route Strength Proprietary Name Applicant
DAROLUTAMIDETABLET;ORAL300MGNUBEQABAYER HEALTHCARE PHARMACEUTICALS INC
Patent Data
Patent No. Patent Expiration Drug Substance Claim Drug Product Claim Patent Use Code
897525410/27/2030DSDPU-2605
965700310/27/2030DSDPU-2605
1001053001/28/2036DS
1038385301/28/2036DS
1071101310/27/2030DSDP
Exclusive Data
Exclusivity Code Exclusivity Expiration
NCE 07/30/2024