KYNMOBI (nda210875)- (10MG,15MG,20MG,25MG,30MG)

Generic Name	APOMORPHINE HYDROCHLORIDE	Innovator	SUMITOMO PHARMA AM
Dosage	10MG,15MG,20MG,25MG,30MG
ParaIV Filing	No	505(b)2 Filing	Yes
Last Patent Expiry	2036-Apr-19	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2023-May-21
GAIN Expiry	None	Drug Complexity	No
Indication	KYNMOBI is a non-ergoline dopamine agonist indicated for the acute, intermittent treatment of “off” episodes in patients with Parkinson’s disease.

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
10MG	**	**	-	-	-
15MG	**	**	-	-	-
20MG	**	**	-	-	-
25MG	**	**	-	-	-
30MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of KYNMOBI