About darolutamide
Darolutamide manufacturers are currently limited to the originators, Bayer and Orion, with Bayer selling it worldwide as Nubeqa. Darolutamide is an oral androgen receptor inhibitor for prostate cancer. Its chemical structure limits entry into the brain, which may reduce side effects such as falls and fatigue. It is approved for non-metastatic castration-resistant and metastatic hormone-sensitive prostate cancer. Pharmaceutical companies can prepare darolutamide tablet and API dossiers for launch after patent expiry.
Darolutamide key facts
|
Property |
Darolutamide |
|---|---|
|
INN |
Darolutamide |
|
Molecular formula / weight |
C19H19ClN6O2 / 398.8 g/mol |
|
ATC code |
L02BB06 |
|
Drug class |
Androgen receptor inhibitor (anti-androgen) |
|
Brand name |
Nubeqa |
|
Originators |
Orion (Finland) and Bayer (Germany) |
|
Dosage form and strength |
Film-coated tablets 300 mg |
|
Dose |
600 mg (two tablets) twice daily |
|
Indications |
Non-metastatic castration-resistant prostate cancer (nmCRPC); metastatic hormone-sensitive prostate cancer (mHSPC), with or without docetaxel |
|
First approval |
US FDA, 30 July 2019 (nmCRPC) |
|
Other US approvals |
mHSPC with docetaxel (2022); mHSPC without docetaxel (2025) |
|
US compound patent |
Expires October 2030 |
|
Other US patents |
Crystal form and composition patents listed to 2038–2042 |
|
Generic status |
No generic approved |
Darolutamide manufacturers and licensing history
Orion discovered darolutamide and developed it with Bayer. The FDA approved Nubeqa on 30 July 2019 for non-metastatic castration-resistant prostate cancer, based on the ARAMIS trial. The EU followed in 2020.
In 2022, the FDA approved darolutamide with docetaxel for metastatic hormone-sensitive prostate cancer, based on ARASENS. In 2025, it was approved for the same disease without docetaxel, based on ARANOTE. Darolutamide competes with apalutamide and enzalutamide.
No generic darolutamide is approved. The US compound patent expires in October 2030, but crystal form and composition patents are listed to 2038–2042, and EU patents have faced oppositions. Buyers should confirm the API's crystal form, GMP status and freedom to operate before choosing a dossier partner.
Darolutamide dosage forms and dossier types
Darolutamide is approved as 300 mg film-coated tablets.
|
Form |
Strengths |
Typical dossier |
Notes |
|---|---|---|---|
|
Darolutamide tablets |
300 mg |
Future US ANDA; EU CTD |
Reference Nubeqa |
|
Darolutamide API |
Bulk |
Future DMF; ASMF |
Crystal form patents apply |
|
Target market |
Dossier format |
Key requirement |
|---|---|---|
|
United States |
Future ANDA |
Compound patent to October 2030; later patents to 2042 |
|
European Union |
Future EU CTD |
SPC expiry; patent oppositions |
|
Other markets |
CTD |
Check local patents |
Darolutamide regulatory and patent status
The FDA approved darolutamide on 30 July 2019, and expanded it to metastatic hormone-sensitive prostate cancer in 2022 and 2025. The US compound patent expires in October 2030, with crystal form and composition patents listed to 2038–2042. No generic is approved. Check the FDA Orange Book and national registers before planning development.
Darolutamide mechanism of action and therapeutic use
Darolutamide binds the androgen receptor and blocks testosterone signalling, stopping prostate cancer cells from growing. Because it crosses into the brain less than other androgen receptor inhibitors, it may cause fewer central nervous system side effects. Darolutamide is used with androgen deprivation therapy for nmCRPC and mHSPC.
Darolutamide licensing and sourcing
Darolutamide is currently available only from Bayer. Companies interested in this molecule usually prepare future generic dossiers or API supply. Current offers and supplier contacts are listed among the darolutamide manufacturers on Pipelinepharma.
Frequently asked questions about darolutamide
Who manufactures darolutamide? Bayer sells darolutamide as Nubeqa, co-developed with Orion.
Is there a generic version of darolutamide? No. No generic darolutamide is approved. The US compound patent expires in October 2030, with other patents listed to 2042.
What is darolutamide used for? Darolutamide is used for non-metastatic castration-resistant and metastatic hormone-sensitive prostate cancer.
What forms and strengths of darolutamide are available? Darolutamide is available as 300 mg film-coated tablets.
How is darolutamide different from apalutamide and enzalutamide? All three are androgen receptor inhibitors. Darolutamide crosses into the brain less, which may reduce side effects such as fatigue and falls.
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