Prescription medicine
Darolutamide Brand names: Nubeqa
Darolutamide (Nubeqa) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the darolutamide FDA label on DailyMed (effective June 3, 2025, Bayer HealthCare Pharmaceuticals Inc.); the NDA 212099 record on Drugs@FDA; every darolutamide label on DailyMed.
Highlights of the record
FDA label of June 3, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageNUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC).
Forms and strengths
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- July 30, 2019 Nubeqa, Bayer Healthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- June 17, 2042 Nubeqa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,501 through July 30, 2026
What is darolutamide used for?
From the label: indications and usageNUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with: non-metastatic castration-resistant prostate cancer (nmCRPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC). ( 1 ) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel. ( 1 ) NUBEQA is indicated for the treatment of adult patients with: non-metastatic castration resistant prostate cancer (nmCRPC) metastatic castration-sensitive prostate cancer (mCSPC) metastatic castration-sensitive prostate cancer (mCSPC) in combination with docetaxel.
Source: FDA drug label (NUBEQA), Bayer HealthCare Pharmaceuticals Inc., effective June 3, 2025 (SPL set 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e), via openFDA; the full label on DailyMed
Is there a generic for darolutamide (Nubeqa)?
No generic darolutamide is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 10 patents for Nubeqa tablets: the compound patent runs to February 27, 2038, and the last listed entry to June 17, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the darolutamide label say about other medicines?
The darolutamide label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name darolutamide. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Docetaxel | warnings and precautions | In ARASENS, ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel and 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% and 1.1%, respectively. |
Other labels that name darolutamide
Source: FDA drug label (NUBEQA), Bayer HealthCare Pharmaceuticals Inc., effective June 3, 2025 (SPL set 1a7cb212-56e4-4b9d-a73d-bfee7fe4735e), via openFDA; the full label on DailyMed
What do FAERS reports show for darolutamide?
The FDA Adverse Event Reporting System holds 5,501 reports that list darolutamide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 670 are coded as a death and 1,200 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (1,986, against a median of 152 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Darolutamide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other