NAROPIN (nda020533)- (1GM/200ML (5MG/ML),20MG/10ML (2MG/ML),40MG/20ML (2MG/ML),50MG/10ML (5MG/ML),75MG/10ML (7.5MG/ML),100MG/20ML (5MG/ML),100MG/10ML (10MG/ML),150MG/20ML (7.5MG/ML),150MG/30ML (5MG/ML),200MG/100ML (2MG/ML),200MG/20ML (10MG/ML),400MG/200ML (2MG/ML),500MG/100ML (5MG/ML))

Generic Name	ROPIVACAINE HYDROCHLORIDE	Innovator	FRESENIUS KABI USA
Dosage	1GM/200ML (5MG/ML),20MG/10ML (2MG/ML),40MG/20ML (2MG/ML),50MG/10ML (5MG/ML),75MG/10ML (7.5MG/ML),100MG/20ML (5MG/ML),100MG/10ML (10MG/ML),150MG/20ML (7.5MG/ML),150MG/30ML (5MG/ML),200MG/100ML (2MG/ML),200MG/20ML (10MG/ML),400MG/200ML (2MG/ML),500MG/100ML (5MG/ML)
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2026-Nov-28	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	NAROPIN is an amide local anesthetic indicated in adults for the production of local or regional anesthesia for surgery and for acute pain management.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
14	0	12

Other Developers

Total Other Developers	10

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1GM/200ML (5MG/ML)	**	**	-	-	-
20MG/10ML (2MG/ML)	**	**	-	-	-
40MG/20ML (2MG/ML)	**	**	-	-	-
50MG/10ML (5MG/ML)	**	**	-	-	-
75MG/10ML (7.5MG/ML)	**	**	-	-	-
100MG/20ML (5MG/ML)	**	**	-	-	-
100MG/10ML (10MG/ML)	**	**	-	-	-
150MG/20ML (7.5MG/ML)	**	**	-	-	-
150MG/30ML (5MG/ML)	**	**	-	-	-
200MG/100ML (2MG/ML)	**	**	-	-	-
200MG/20ML (10MG/ML)	**	**	-	-	-
400MG/200ML (2MG/ML)	**	**	-	-	-
500MG/100ML (5MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	8

Manufacturing Details of NAROPIN