Details for New Drug Application (NDA): 219491

NDA 219491 describes NUZOLVENCE, which is a drug marketed by Entasis Therap and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the NUZOLVENCE profile page.

The generic ingredient in NUZOLVENCE is zoliflodacin. One supplier is listed for this compound. Additional details are available on the zoliflodacin profile page.

Summary for 219491

Tradename:	NUZOLVENCE
Applicant:	Entasis Therap
Ingredient:	zoliflodacin
Patents:	6

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 219491

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

Dosage:

FOR SUSPENSION;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Suppliers and Packaging for NDA: 219491

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
NUZOLVENCE	zoliflodacin	FOR SUSPENSION;ORAL	219491	NDA	La Jolla Pharmaceutical Company	68547-915	68547-915-10	1 PACKET in 1 CARTON (68547-915-10) / 1 FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	3GM/PACKET
Approval Date:	Dec 12, 2025	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Dec 12, 2035
Regulatory Exclusivity Use:	GENERATING ANTIBIOTIC INCENTIVES NOW
Regulatory Exclusivity Expiration:	Dec 12, 2030
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Patent:		Patent Expiration:	Jun 20, 2030	Product Flag?		Substance Flag?	Y	Delist Request?

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