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 |
What a generic Liraglutide would have to match
Forms and strengths
Injection: 18 mg per 3 mL (6 mg per mL) clear, colorless solution in a prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg. Injection: 6 mg per mL solution in a prefilled, single-patient-use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg. (3)
How it is supplied
How Supplied Liraglutide Injection is a clear, colorless solution and is supplied as follows: NDC Liraglutide Injection (6 mg per mL) Package Factor 71288- 563 -84 18 mg per 3 mL prefilled, Single-Patient-Use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg 3 pens in a carton 71288- 563 -85 18 mg per 3 mL prefilled, Single-Patient-Use pen that delivers doses of 0.6 mg, 1.2 mg, or 1.8 mg 2 pens in a carton Recommended Storage Prior to first use, Liraglutide Injection should be stored in a refrigerator between 36° to 46°F (2° to 8°C). Do not store in the freezer or directly adjacent to the refrigerator cooling element. Do not freeze Liraglutide Injection and do not use Liraglutide...
A generic has to match the reference product on active ingredient, strength, dosage form and route. These are the forms the FDA label currently lists. Source: FDA Structured Product Labeling, label effective 2026-07-27.
Recalls involving Liraglutide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Lupin Pharmaceuticals Inc. | FL | Class II | 2026-04-24 | Presence of particulate matter: a white thread-like structure in the c |
| Novo Nordisk Inc | NJ | Class II | 2021-03-22 | Temperature Abuse: product samples were stored at temperatures below 3 |
Supply history matters to availability: a recalled batch is a batch that did not reach patients. Most records here are compounded preparations rather than the approved product. Source: openFDA drug enforcement reports, checked 2026-11-09.
Other drugs and when their protection ends
Ordered by the date the last listed patent or exclusivity expires.
- Calcitoninno patent or exclusivity listed
- Cetrorelixno patent or exclusivity listed
- Cosyntropinno patent or exclusivity listed
- Enfuvirtideno patent or exclusivity listed
- Eptifibatideno patent or exclusivity listed
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 2026-11-01. 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.
Related data
- Liraglutide clinical trials →Registered studies, phases and status
- Which peptides are FDA-approved →Approval status for every peptide, from Drugs@FDA
- FDA drug shortage tracker →Which peptide drugs are in shortage now, with the FDA-stated cause
- When peptide drugs go generic →Patent and exclusivity expiry dates from the FDA Orange Book