FDA Orange Book
Is there a generic for Gvoke HypoPen?
Gvoke HypoPen contains glucagon. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gvoke HypoPen (glucagon). The Orange Book shows its last listed patent expires April 22, 2036.
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Gvoke HypoPen products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, subcutaneous | 0.5MG/0.1ML (0.5MG/0.1ML) | Marketed (Rx) | None | 0 | None |
| solution, subcutaneous | 1MG/0.2ML (1MG/0.2ML) | Marketed (Rx) | None | 0 | None |
NDA 212097, held by XERIS PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Gvoke HypoPen patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9649364 | April 22, 2036 | Drug product | U-2742 | 212097 |
| 11590205 | April 22, 2036 | Drug product | U-2742 | 212097 |
Gvoke HypoPen NDC codes
Questions
Is there a generic for Gvoke HypoPen?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Gvoke HypoPen (glucagon). The Orange Book shows its last listed patent expires April 22, 2036.
What is the generic name for Gvoke HypoPen?
The active ingredient in Gvoke HypoPen is glucagon, per the FDA Orange Book.
When does the Gvoke HypoPen patent expire?
The last patent listed for Gvoke HypoPen in the Orange Book expires April 22, 2036. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.
More on Gvoke HypoPen and Glucagon
- What is Glucagon used for?FDA label uses
- Is Glucagon a controlled substance?Federal schedule
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- NDC 72065-120Gvoke HypoPen NDC record
- NDC 72065-121Gvoke HypoPen NDC record