department

Clinical
Regulatory
Medical Affairs
Commercial
R&D / Discovery
Biostatistics / Data
Manufacturing / CMC
Market Access

therapeutic area

Oncology
Immunology
Neuroscience
Cardiovascular
Metabolic
Rare Disease
Infectious Disease

location & type

Remote Only
US Only
California
Massachusetts
Internships
Phase 3 Roles
All Jobs →

when

Latest
Archive

by source

All Sources
Sources Page

by activity

Most Active
Biggest Pipelines
Recently Active

hiring

Companies Hiring Now
Big Pharma Roles
All Companies →

Drugs & Pipeline

intelligence

Drugs
Patent Cliff

research

Publications
Topics

window

Next 90 Days
All (incl. Past)

by type

PDUFAs
Approvals
Earnings
Readouts

Sign In Subscribe

pharmadog

fetch the data · sniff the signal

Discover

Calendar
Drugs
Companies
News

Hubs

Topics
Jobs
Patent cliff
Publications

Tools

Compare
Search
Bookmarks

Trust

About
Sources
Contact

Legal

Privacy
Terms
Pricing

© 2026 pharmadog.xyz

made by humans and a good dog

home
jobs
news
cal
search

Nubeqa · pharmadog

pharmadog
drugs
Nubeqa

drug

patient view →

darolutamide

Marketedupdated 2mo ago

by Bayer HealthCare Pharmaceuticals Inc

Approved

community read0 votes

all catalysts(0)

nothing on the calendar yet

News(0)

no news has mentioned this drug yet

brand

Nubeqa

generic

darolutamide

indication

Castration-Resistant Prostate Cancer (CRPC)

phase

marketed

Patent cliff

source: FDA Orange Book

first barrier falls

Jun 3, 2028

~1.9 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 107110134.3y
Oct 27, 2030compositionUS 110467134.3y
Oct 27, 2030compositionUS 96570034.3y

FDA exclusivities (1)

Jun 3, 2028I-971Indication (3y)1.9y

comments(0)

5-min edit window · permanent after that

sign in to leave a comment · permanent archive after 5 minutes

no comments yet — first sniff?

Data sources

ClinicalTrials.gov

last refreshed 31m ago

Found something off?

🐶 something off?

Report a data issue

Tell Bork what looks wrong — wrong sponsor, stale phase, mislinked ticker, anything. We’ll triage and fix.

Trials studying darolutamide

phase2A Study of HRS-5041 Tablets Combined With Antitumor Therapy in Subjects With Advanced Prostate Cancerrecruitingn=100
phase1QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interactionnot yet recruitingn=48
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 Therapiesactive not recruitingn=985
—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 Cancerrecruitingn=100
phase1A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)recruitingn=60
—An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatmentnot yet recruitingn=800
phase2A 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.active not recruitingn=223
phase1Safety, Pharmacokinetics, and Preliminary Efficacy of VIR-5500 (AMX-500) in Prostate Cancerrecruitingn=390

more trials →