FDA Orange Book
Generic for Victoza
Victoza 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 Victoza is liraglutide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP1, AP2.
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Victoza 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) | AP1 | 11 | AP1, AP2 |
NDA 022341, 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) |
Victoza patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8114833 | August 13, 2025 | Drug substance, Drug product | None | 022341 |
| 8114833*PED | February 13, 2026 | Method of use | None | 022341 |
| 9968659 | January 9, 2037 | Method of use | U-2313 | 022341 |
| 9968659*PED | July 9, 2037 | Method of use | None | 022341 |
Victoza NDC codes
Questions
Is there a generic for Victoza?
Yes. The generic name for Victoza 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 Victoza?
The active ingredient in Victoza is liraglutide, per the FDA Orange Book.
When does the Victoza patent expire?
The last patent listed for Victoza 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.
More on Victoza and Liraglutide
- What is Liraglutide used for?FDA label uses
- Is Liraglutide a controlled substance?Federal schedule
- Generic for SaxendaFDA Orange Book
- GLP-1 Receptor Agonists listFDA drug class
- Victoza Medicare Part D coverageBy plan and state
- NDC 0169-4060Victoza NDC record
- NDC 50090-2853Victoza NDC record
- NDC 50090-4503Victoza NDC record