FDA Orange Book
Generic for Saxenda
Saxenda contains liraglutide. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Saxenda is liraglutide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
Run it in Rivvi
Map Saxenda and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Saxenda products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 18MG/3ML (6MG/ML) | Marketed (Rx) | AP2 | 11 | AP1, AP2 |
NDA 206321, held by NOVO NORDISK INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic liraglutide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 215503 | AP1 (A-rated, therapeutically equivalent) | December 23, 2024 | 18MG/3ML (6MG/ML) |
| NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD | 218115 | AP1 (A-rated, therapeutically equivalent) | April 2, 2025 | 18MG/3ML (6MG/ML) |
| LUPIN LTD | 215421 | AP1 (A-rated, therapeutically equivalent) | July 22, 2025 | 18MG/3ML (6MG/ML) |
| TEVA PHARMACEUTICALS DEVELOPMENT INC | 214568 | AP2 (A-rated, therapeutically equivalent) | August 27, 2025 | 18MG/3ML (6MG/ML) |
| ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD | 217590 | AP1 (A-rated, therapeutically equivalent) | January 14, 2026 | 18MG/3ML (6MG/ML) |
| BIOCON PHARMA LTD | 217063 | AP2 (A-rated, therapeutically equivalent) | February 24, 2026 | 18MG/3ML (6MG/ML) |
| ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD | 217234 | AP2 (A-rated, therapeutically equivalent) | February 24, 2026 | 18MG/3ML (6MG/ML) |
| BIOCON PHARMA LTD | 215245 | AP1 (A-rated, therapeutically equivalent) | March 11, 2026 | 18MG/3ML (6MG/ML) |
| FRESENIUS KABI USA LLC | 212552 | AP1 (A-rated, therapeutically equivalent) | March 30, 2026 | 18MG/3ML (6MG/ML) |
| MYLAN INSTITUTIONAL LLC | 213155 | AP1 (A-rated, therapeutically equivalent) | June 15, 2026 | 18MG/3ML (6MG/ML) |
| SANDOZ INC | 212972 | AP1 (A-rated, therapeutically equivalent) | July 1, 2026 | 18MG/3ML (6MG/ML) |
Saxenda patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8114833 | August 13, 2025 | Drug product | None | 206321 |
| 8114833*PED | February 13, 2026 | Method of use | None | 206321 |
| 9968659 | January 9, 2037 | Method of use | U-2438 | 206321 |
| 9968659*PED | July 9, 2037 | Method of use | None | 206321 |
Saxenda NDC codes
Questions
Is there a generic for Saxenda?
Yes. The generic name for Saxenda is liraglutide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
What is the generic name for Saxenda?
The active ingredient in Saxenda is liraglutide, per the FDA Orange Book.
When does the Saxenda patent expire?
The last patent listed for Saxenda in the Orange Book expires July 9, 2037. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.