Home / Generic availability / Exenatide
When will generic Exenatide be available?
Based on the patents and exclusivity the FDA lists today, generic exenatide cannot be marketed in the United States before 2031-04-04, when the last listed protection expires.
Patents listed with the FDA
38 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 6515117 | 2025-10-04 | drug substance, drug product | BYDUREON BCISE |
| 6515117 | 2025-10-04 | drug substance, drug product | BYDUREON |
| 6515117 | 2025-10-04 | drug substance, drug product | BYDUREON PEN |
| 6515117*PED | 2026-04-04 | method of use | BYDUREON BCISE |
| 6515117*PED | 2026-04-04 | method of use | BYDUREON |
| 6515117*PED | 2026-04-04 | method of use | BYDUREON PEN |
| 8329648 | 2026-08-18 | method of use | BYDUREON BCISE |
| 8906851 | 2026-08-18 | method of use | BYDUREON BCISE |
| 9884092 | 2026-08-18 | method of use | BYDUREON BCISE |
| 8329648 | 2026-08-18 | method of use | BYDUREON |
| 8906851 | 2026-08-18 | method of use | BYDUREON |
| 9884092 | 2026-08-18 | method of use | BYDUREON |
| 8329648 | 2026-08-18 | method of use | BYDUREON PEN |
| 8906851 | 2026-08-18 | method of use | BYDUREON PEN |
| 9884092 | 2026-08-18 | method of use | BYDUREON PEN |
| 8329648*PED | 2027-02-18 | method of use | BYDUREON BCISE |
| 8906851*PED | 2027-02-18 | method of use | BYDUREON BCISE |
| 9884092*PED | 2027-02-18 | method of use | BYDUREON BCISE |
| 8329648*PED | 2027-02-18 | method of use | BYDUREON |
| 8906851*PED | 2027-02-18 | method of use | BYDUREON |
| 9884092*PED | 2027-02-18 | method of use | BYDUREON |
| 8329648*PED | 2027-02-18 | method of use | BYDUREON PEN |
| 8906851*PED | 2027-02-18 | method of use | BYDUREON PEN |
| 9884092*PED | 2027-02-18 | method of use | BYDUREON PEN |
| 8501698 | 2027-06-20 | method of use | BYDUREON BCISE |
| 8501698 | 2027-06-20 | drug product | BYDUREON |
| 8501698 | 2027-06-20 | drug product | BYDUREON PEN |
| 8501698*PED | 2027-12-20 | method of use | BYDUREON BCISE |
| 8501698*PED | 2027-12-20 | method of use | BYDUREON |
| 8501698*PED | 2027-12-20 | method of use | BYDUREON PEN |
| 8361972 | 2028-03-21 | method of use | BYDUREON BCISE |
| 8361972 | 2028-03-21 | method of use | BYDUREON |
| 8361972 | 2028-03-21 | method of use | BYDUREON PEN |
| 8361972*PED | 2028-09-21 | method of use | BYDUREON BCISE |
| 8361972*PED | 2028-09-21 | method of use | BYDUREON |
| 8361972*PED | 2028-09-21 | method of use | BYDUREON PEN |
| 8895033 | 2030-10-04 | drug product | BYDUREON BCISE |
| 8895033*PED | 2031-04-04 | method of use | BYDUREON BCISE |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| BYETTA | Brand (NDA) | ASTRAZENECA AB | 2005-04-28 | reference listed drug |
| BYDUREON, BYDUREON PEN | Brand (NDA) | ASTRAZENECA AB | 2012-01-27 | reference listed drug |
| EXENATIDE SYNTHETIC | Generic (ANDA) | AMNEAL EU LTD | 2024-11-19 | |
| BYDUREON BCISE | Brand (NDA) | ASTRAZENECA AB | 2017-10-20 | reference listed drug |
What a generic Exenatide would have to match
Forms and strengths
Exenatide Injection, USP is a clear, colorless sterile solution for subcutaneous injection containing 250 mcg/mL exenatide, USP supplied as follows: 5 mcg per dose in a single-patient-use prefilled pen containing 300 mcg/1.2 mL (250mcg/mL), 60 doses. 10 mcg per dose in a single-patient-use prefilled pen containing 600 mcg/2.4 mL (250mcg/mL), 60 doses. Exenatide injection is supplied as: 5 mcg per dose, in a single-patient-use prefilled pen containing 300 mcg/1.2 mL (250 mcg/mL), 60 doses. 10 mcg per dose, in a single-patient-use prefilled pen containing 600 mcg/2.4 mL (250 mcg/mL), 60 doses.
How it is supplied
16.1 How Supplied Exenatide Injection, USP is supplied as a clear, colorless sterile solution for subcutaneous injection containing 250 mcg/mL exenatide, USP. The following packages are available: 5 mcg per dose, in a single-patient-use prefilled pen containing 300 mcg/1.2 mL (250mcg/mL), 60 doses: NDC 70121-1685-1 10 mcg per dose, in a single-patient-use prefilled pen containing 600 mcg/2.4 mL (250mcg/mL), 60 doses: NDC 70121-1686-1 16.2 Storage and Handling Store exenatide injection in the refrigerator at 36 ○ to 46 ○ F (2 ○ to 8 ○ C). After first use, exenatide injection can be kept at a temperature not to exceed 77 ○ F (25 ○ C). Do not freeze. Do not use exenatide injection if it has...
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 2026-05-27.
Recalls involving Exenatide
| Firm | State | Class | Initiated | Reason given |
|---|---|---|---|---|
| Amneal Pharmaceuticals of New York, LLC | NY | Class II | 2026-08-28 | Defective Delivery System: Possibility of no medication in the prefill |
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.
- Linaclotideprotection runs to February 2027
- Semaglutideprotection runs to March 2027
- Lanreotideprotection runs to March 2027
- Tirzepatideprotection runs to May 2027
- Octreotideprotection runs to June 2027
Frequently asked questions
When will generic Exenatide be available?
Based on the patents and exclusivity the FDA lists today, generic exenatide cannot be marketed in the United States before 2031-04-04, 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
- Exenatide 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