FDA Orange Book · active-ingredient family
Liraglutide
Liraglutide is approved as 2 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SAXENDA · NDA 206321
2
Brand (NDA)
9
Generics (ANDA)
4
Listed patents
1
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SAXENDARLD | NOVO | NDA 206321 | AP2 | Dec 23, 2014 | |
| VICTOZARLD | NOVO NORDISK INC | NDA 022341 | AP1 | Jan 25, 2010 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LIRAGLUTIDE | FRESENIUS KABI USA | ANDA 212552 | AP1 | Mar 30, 2026 | |
| LIRAGLUTIDE | BIOCON PHARMA | ANDA 215245 | AP1 | Mar 11, 2026 | |
| LIRAGLUTIDE | BIOCON PHARMA | ANDA 217063 | AP2 | Feb 24, 2026 | |
| LIRAGLUTIDE | ORBICULAR | ANDA 217234 | AP2 | Feb 24, 2026 | |
| LIRAGLUTIDE | ORBICULAR | ANDA 217590 | AP1 | Jan 14, 2026 | |
| LIRAGLUTIDE | TEVA PHARMS | ANDA 214568 | AP2 | Aug 27, 2025 | |
| LIRAGLUTIDE | LUPIN | ANDA 215421 | AP1 | Jul 22, 2025 | |
| LIRAGLUTIDE | NANJING KING FRIEND | ANDA 218115 | AP1 | Apr 02, 2025 | |
| LIRAGLUTIDE | HIKMA | ANDA 215503 | AP1 | Dec 23, 2024 |
Marketing exclusivity (1)
- PCPatent-challenge (180-day generic) exclusivity
Feb 24, 2026
4 mo ago
Listed patents (4)
| 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 |
Liraglutide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
