Darolutamide

Sold as NUBEQA · given by oral

Ten years or more until it comes off patent
15.8 yr
Until anyone may copy it
Protection runs to 2042-06-17
40
Trials running now
158 registered in total
In routine use
Furthest stage reached
already in routine clinical use
3
Organisations running trials
lead sponsors on record
01

Who owns it, and until when

Bayer Healthcare Pharmaceuticals I
Approval holder
the only company permitted to sell it today
2042-06
Last patent expires
latest patent filed against this product
2028-06
FDA exclusivity ends
a separate protection granted at approval

Whichever date falls later is when other manufacturers may apply to sell copies. Price typically falls steeply within a year of that point, and with it any company's ability to recover the cost of new research on the molecule. That is when it becomes a candidate for the ledger on the first tab.

02

What it is being tested for

Prostate CancerMetastatic Castration-resistant ProstaMetastatic Prostate Cancer
03

Who is paying for the research

Bayer
Company
15
Janssen Research & Development, LL
Company
2
University College, London
University or hospital
2

Who funds the trials matters after protection lapses. Company-funded work usually stops once exclusivity ends; university, hospital and government-funded work does not, and is the research most likely to continue on this molecule afterwards.

04

The trials themselves

NCT06660862In routine use2026 · 80 people · not yet recruiting
Evaluating Treatment Outcomes Using Daroluta

Expiry dates are what the patent holder has filed; litigation, paediatric extensions and settlements routinely move them, so read these as the earliest plausible date rather than a schedule. Not medical advice.

← Back to the patent line