ORGOVYX (nda214621)- (120MG)

Generic Name	RELUGOLIX	Innovator	SUMITOMO PHARMA
Dosage	120MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2037-Sep-29	NCE Excl Expiry	2025-Dec-18
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	ORGOVYX is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	16

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
120MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of ORGOVYX