FDA Orange Book · active-ingredient family
Glucagon
Glucagon is approved as 3 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:GVOKE VIALDX · NDA 212097
3
Brand (NDA)
4
Generics (ANDA)
5
Listed patents
2
Exclusivity periods
Brand (NDA) products · injectable, powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| GVOKE VIALDXRLD×6 | XERIS | NDA 212097 | — | Mar 14, 2025 | |
| BAQSIMIRLD | AMPHASTAR PHARMS INC | NDA 210134 | — | Jul 24, 2019 | |
| GLUCAGONRLD | LILLY | NDA 020928 | — | Sep 11, 1998 |
Generic (ANDA) products (4)
Marketing exclusivity (2)
- CGTFDA marketing exclusivity
Apr 18, 2026
2 mo ago
- NPPNew patient population exclusivity (3 years)
Mar 17, 2028
in 1 yr 9 mo
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10213487 | Feb 16, 2036 | in 9 yr 10 mo | ProductU-2604 |
| 12370241 | Feb 16, 2036 | in 9 yr 10 mo | ProductU-2604 |
| 9649364 | Apr 22, 2036 | in 10 yr | ProductU-2742 |
| 11590205 | Apr 22, 2036 | in 10 yr | ProductU-2742 |
| 10765602 | Sep 23, 2039 | in 13 yr 5 mo | Product |
Glucagon — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
