ZYNRELEF KIT (nda211988)- (60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML),200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML),300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML),400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML))

Generic Name	BUPIVACAINE; MELOXICAM	Innovator	HERON THERAPS INC
Dosage	60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML),200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML),300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML),400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2036-Apr-21	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	2024-May-12
GAIN Expiry	None	Drug Complexity	No
Indication	ZYNRELEF contains bupivacaine, an amide local anesthetic, and meloxicam, a nonsteroidal anti-inflammatory drug (NSAID), and is indicated in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures.

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
60MG/2.3ML (29.25MG/ML);1.8MG/2.3ML (0.88MG/ML)	**	**	-	-	-
200MG/7ML (29.25MG/ML);6MG/7ML (0.88MG/ML)	**	**	-	-	-
300MG/10.5ML (29.25MG/ML);9MG/10.5ML (0.88MG/ML)	**	**	-	-	-
400MG/14ML (29.25MG/ML);12MG/14ML (0.88MG/ML)	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of ZYNRELEF KIT