SUFENTA PRESERVATIVE FREE (nda019050)- (EQ 0.05MG BASE/ML)

Generic Name	SUFENTANIL CITRATE	Innovator	RISING
Dosage	EQ 0.05MG BASE/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Sufentanil Citrate Injection is an opioid agonist indicated: • as an analgesic adjunct in the maintenance of balanced general anesthesia in patients who are intubated and ventilated. • as a primary anesthetic agent for the induction and maintenance of anesthesia with 100% oxygen in patients undergoing major surgical procedures, in patients who are intubated and ventilated, such as cardiovascular surgery or neurosurgical procedures in the sitting position, to provide favorable myocardial and cerebral oxygen balance or when extended postoperative ventilation is anticipated. • for epidural administration as an analgesic combined with low dose (usually 12.5 mg per administration) bupivacaine usually during labor and vaginal delivery.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

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 0.05MG BASE/ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of SUFENTA PRESERVATIVE FREE