Orange Book product · Brand (NDA)

SAXENDA

LIRAGLUTIDE

Brand (NDA)NDA 206321TE AP2RX NOVO

Dec 23, 2014

Approved

Brand (NDA)

Application

AP2

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 23, 2014
11 yr 8 mo ago
Patent 8114833 expires
Listed drug product patent expiration.
Aug 13, 2025
10 mo ago
Patent 8114833*PED expires
Listed listed patent expiration.
Feb 13, 2026
4 mo ago
Today
Patent 9968659 expires
Listed method-of-use patent (U-2438) expiration.
Jan 09, 2037
in 10 yr 9 mo
Patent 9968659*PED expires
Listed listed patent expiration.
Jul 09, 2037
in 11 yr 3 mo

Active ingredient

LIRAGLUTIDE

Strength

18MG/3ML (6MG/ML)

Dosage form

SOLUTION

Route

SUBCUTANEOUS

TE code

AP2

Application

NDA 206321

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
8114833	Aug 13, 2025	10 mo ago	Product
8114833*PED	Feb 13, 2026	4 mo ago
9968659	Jan 09, 2037	in 10 yr 9 mo	U-2438
9968659*PED	Jul 09, 2037	in 11 yr 3 mo