NUBEQA (nda212099)- (300MG)

Generic Name	DAROLUTAMIDE	Innovator	BAYER HEALTHCARE
Dosage	300MG
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2038-Feb-27	NCE Excl Expiry	2024-Jul-30
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NUBEQA is an androgen receptor inhibitor indicated for the treatment of patients with non-metastatic castration-resistant prostate cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	1	0

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
300MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of NUBEQA