Home / Generic availability / Glucagon
When will generic Glucagon be available?
Based on the patents and exclusivity the FDA lists today, generic glucagon cannot be marketed in the United States before 2039-09-23, when the last listed protection expires.
Patents listed with the FDA
8 unexpired or current listing(s).
| Patent | Expires | Covers | Product |
|---|---|---|---|
| 10213487 | 2036-02-16 | drug product | BAQSIMI |
| 12370241 | 2036-02-16 | drug product | BAQSIMI |
| 11590205 | 2036-04-22 | drug product | GVOKE PFS |
| 9649364 | 2036-04-22 | drug product | GVOKE PFS |
| 11590205 | 2036-04-22 | drug product | GVOKE HYPOPEN |
| 9649364 | 2036-04-22 | drug product | GVOKE HYPOPEN |
| 11590205 | 2036-04-22 | drug product | GVOKE KIT |
| 10765602 | 2039-09-23 | drug product | BAQSIMI |
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 |
|---|---|---|---|
| CGT | 2026-04-18 | Competitive generic therapy (180 days) | GLUCAGON |
| NPP | 2028-03-17 | New patient population | BAQSIMI |
Approved products
| Product | Type | Applicant | Approved | |
|---|---|---|---|---|
| GLUCAGON | Brand (NDA) | ELI LILLY AND CO | reference listed drug | |
| GLUCAGEN | Brand (NDA) | NOVO NORDISK PHARMACEUTICALS INC | 1998-06-22 | reference listed drug |
| GLUCAGON | Brand (NDA) | ELI LILLY AND CO | 1998-09-11 | reference listed drug |
| GLUCAGON | Brand (NDA) | FRESENIUS KABI USA LLC | 2015-05-08 | reference listed drug, reference standard |
| GLUCAGON | Generic (ANDA) | MYLAN LABORATORIES LTD | 2024-12-12 | |
| GLUCAGON | Generic (ANDA) | AMPHASTAR PHARMACEUTICALS INC | 2020-12-28 | reference standard |
| BAQSIMI | Brand (NDA) | AMPHASTAR PHARMACEUTICALS INC | 2019-07-24 | reference listed drug, reference standard |
| GVOKE HYPOPEN, GVOKE KIT, GVOKE PFS, GVOKE VIALDX | Brand (NDA) | XERIS PHARMACEUTICALS INC | 2019-09-10 | reference listed drug, reference standard |
| GLUCAGON | Generic (ANDA) | LUPIN LTD | 2025-07-22 | |
| GLUCAGON | Generic (ANDA) | CIPLA LTD | 2025-09-15 |
Frequently asked questions
When will generic Glucagon be available?
Based on the patents and exclusivity the FDA lists today, generic glucagon cannot be marketed in the United States before 2039-09-23, 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.