Home / Generic availability / Liraglutide
When will generic Liraglutide be available?
Based on the patents and exclusivity the FDA lists today, generic liraglutide cannot be marketed in the United States before 2037-07-09, when the last listed protection expires.
Patents listed with the FDA
8 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 8114833 | 2025-08-13 | drug substance, drug product | VICTOZA |
| 8114833 | 2025-08-13 | drug product | SAXENDA |
| 8114833*PED | 2026-02-13 | method of use | VICTOZA |
| 8114833*PED | 2026-02-13 | method of use | SAXENDA |
| 9968659 | 2037-01-09 | method of use | VICTOZA |
| 9968659 | 2037-01-09 | method of use | SAXENDA |
| 9968659*PED | 2037-07-09 | method of use | VICTOZA |
| 9968659*PED | 2037-07-09 | method of use | SAXENDA |
FDA exclusivity
Exclusivity is granted by the FDA and runs separately from patents. It can block a generic even after a patent expires.
| Code | Expires | What it is | Product |
|---|---|---|---|
| PC | 2026-02-24 | Exclusivity tied to a specific approval condition | LIRAGLUTIDE |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| VICTOZA | Brand (NDA) | NOVO NORDISK INC | 2010-01-25 | reference listed drug, reference standard |
| SAXENDA | Brand (NDA) | NOVO NORDISK INC | 2014-12-23 | reference listed drug, reference standard |
| LIRAGLUTIDE | Generic (ANDA) | FRESENIUS KABI USA LLC | 2026-03-30 | |
| LIRAGLUTIDE | Generic (ANDA) | SANDOZ INC | 2026-07-01 | |
| LIRAGLUTIDE | Generic (ANDA) | MYLAN INSTITUTIONAL LLC | 2026-06-15 | |
| LIRAGLUTIDE | Generic (ANDA) | TEVA PHARMACEUTICALS DEVELOPMENT INC | 2025-08-27 | |
| LIRAGLUTIDE | Generic (ANDA) | BIOCON PHARMA LTD | 2026-03-11 | |
| LIRAGLUTIDE | Generic (ANDA) | LUPIN LTD | 2025-07-22 | |
| LIRAGLUTIDE | Generic (ANDA) | HIKMA PHARMACEUTICALS USA INC | 2024-12-23 | |
| LIRAGLUTIDE | Generic (ANDA) | BIOCON PHARMA LTD | 2026-02-24 | |
| LIRAGLUTIDE | Generic (ANDA) | ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD | 2026-02-24 | |
| LIRAGLUTIDE | Generic (ANDA) | ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LTD | 2026-01-14 | |
| LIRAGLUTIDE | Generic (ANDA) | NANJING KING FRIEND BIOCHEMICAL PHARMACEUTICAL CO LTD | 2025-04-02 |
Frequently asked questions
When will generic Liraglutide be available?
Based on the patents and exclusivity the FDA lists today, generic liraglutide cannot be marketed in the United States before 2037-07-09, when the last listed protection expires.
Does this date guarantee a generic launches then?
No. It is the date the last protection the FDA currently lists expires. Patents can be challenged, licensed, or designed around, which can bring a generic earlier, and new patents can be listed later. Treat it as the outer limit of the brand's protection, not a launch forecast.
What is the difference between a patent and exclusivity?
A patent is granted by the patent office and listed with the FDA by the brand. Exclusivity is granted by the FDA itself on approval. They run independently, and exclusivity can keep a generic off the market even after a patent has expired.
What is a tentative approval?
It means the FDA has reviewed a generic application and judged it acceptable, but cannot allow it to be marketed yet because patents or exclusivity are still running. It is the clearest signal that a generic is ready to launch once the dates clear.
Source: FDA Orange Book via openFDA, with tentative-approval data from Drugs@FDA. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.