Orange Book product · Generic (ANDA)
LIRAGLUTIDE
LIRAGLUTIDE
At a glance
Aug 27, 2025
Approved
Generic (ANDA)
Application
AP2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 27, 2025
10 mo ago
Exclusivity ends · PC
Patent-challenge (180-day generic) exclusivity
Feb 24, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
LIRAGLUTIDE
Strength
18MG/3ML (6MG/ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
AP2
Application
ANDA 214568
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of LIRAGLUTIDE
- 2014SAXENDABrand (NDA)
NDA 206321 · NOVO
- 2010VICTOZABrand (NDA)
NDA 022341 · NOVO NORDISK INC
- 2026LIRAGLUTIDEGeneric (ANDA)
ANDA 212552 · FRESENIUS KABI USA
- 2026LIRAGLUTIDEGeneric (ANDA)
ANDA 215245 · BIOCON PHARMA
- 2026LIRAGLUTIDEGeneric (ANDA)
ANDA 217063 · BIOCON PHARMA
- 2026LIRAGLUTIDEGeneric (ANDA)
ANDA 217234 · ORBICULAR
- 2026LIRAGLUTIDEGeneric (ANDA)
ANDA 217590 · ORBICULAR
- 2025LIRAGLUTIDEGeneric (ANDA)
ANDA 215421 · LUPIN
- 2025LIRAGLUTIDEGeneric (ANDA)
ANDA 218115 · NANJING KING FRIEND
- 2024LIRAGLUTIDEGeneric (ANDA)
ANDA 215503 · HIKMA
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Feb 24, 2026
4 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
