Details for New Drug Application (NDA): 219132

NDA 219132 describes AQNEURSA, which is a drug marketed by Intrabio and is included in one NDA. It is available from one supplier. Additional details are available on the AQNEURSA profile page.

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

Summary for 219132

Tradename:	AQNEURSA
Applicant:	Intrabio
Ingredient:	levacetylleucine
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 219132

Constraining patent/regulatory exclusivity:

TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG

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: 219132

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
AQNEURSA	levacetylleucine	FOR SUSPENSION;ORAL	219132	NDA	IntraBio Inc	83853-101	83853-101-01	28 PACKET in 1 CARTON (83853-101-01) / 1 GRANULE, FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION;ORAL			Strength	1GM/PACKET
Approval Date:	Sep 24, 2024	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 24, 2029
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Sep 24, 2031
Regulatory Exclusivity Use:	TREATMENT OF NEUROLOGICAL MANIFESTATIONS OF NIEMANN-PICK DISEASE TYPE C (NPC) IN ADULTS AND PEDIATRIC PATIENTS WEIGHING GREATER THAN OR EQUAL TO 15 KG

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