Orange Book product · Brand (NDA)

AQNEURSA

LEVACETYLLEUCINE

Brand (NDA)NDA 219132RX INTRABIO

Sep 24, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 24, 2024
1 yr 9 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 24, 2029
in 3 yr 4 mo
Exclusivity ends · ODE-498
Orphan-drug exclusivity (7 years)
Sep 24, 2031
in 5 yr 4 mo
Patent 11400067 expires
Listed method-of-use patent (U-4170) expiration.
Apr 19, 2037
in 11 yr
Patent 12433862 expires
Listed method-of-use patent (U-4284) expiration.
Apr 19, 2037
in 11 yr
Patent 12433863 expires
Listed method-of-use patent (U-4285) expiration.
Apr 19, 2037
in 11 yr

Active ingredient

LEVACETYLLEUCINE

Strength

1GM/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

NDA 219132

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11400067	Apr 19, 2037	in 11 yr	U-4170
12433862	Apr 19, 2037	in 11 yr	U-4284
12433863	Apr 19, 2037	in 11 yr	U-4285