VYLEESI (AUTOINJECTOR) (nda210557)- (EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML))

Generic Name	BREMELANOTIDE ACETATE	Innovator	COSETTE
Dosage	EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2041-Apr-29	NCE Excl Expiry	2024-Jun-21
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	VYLEESI is a melanocortin receptor agonist indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to: • A co-existing medical or psychiatric condition, • Problems with the relationship, or • The effects of a medication or drug substance.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of VYLEESI (AUTOINJECTOR)