FDA Orange Book
Is there a generic for Baqsimi?
Baqsimi 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 Baqsimi (glucagon). The Orange Book shows its last listed patent expires September 23, 2039 and its last listed exclusivity ends March 17, 2028.
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Baqsimi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, nasal | 3MG | Marketed (Rx) | None | 0 | None |
NDA 210134, held by AMPHASTAR PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Baqsimi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10213487 | February 16, 2036 | Drug product | U-2604 | 210134 |
| 12370241 | February 16, 2036 | Drug product | U-2604 | 210134 |
| 10765602 | September 23, 2039 | Drug product | None | 210134 |
Baqsimi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | March 17, 2028 | 210134 |
Baqsimi NDC codes
Questions
Is there a generic for Baqsimi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Baqsimi (glucagon). The Orange Book shows its last listed patent expires September 23, 2039 and its last listed exclusivity ends March 17, 2028.
What is the generic name for Baqsimi?
The active ingredient in Baqsimi is glucagon, per the FDA Orange Book.
When does the Baqsimi patent expire?
The last patent listed for Baqsimi in the Orange Book expires September 23, 2039. 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 Baqsimi and Glucagon
- What is Baqsimi used for?FDA label uses
- Is Baqsimi a controlled substance?Federal schedule
- Is Glucagon a controlled substance?Federal schedule
- Generic for Gvoke HypoPenFDA Orange Book
- Generic for Gvoke KitFDA Orange Book
- Generic for Gvoke PFSFDA Orange Book
- Antihypoglycemic Agents listFDA drug class
- Gastrointestinal Motility Inhibitors listFDA drug class
- NDC 0548-8351Baqsimi NDC record
- NDC 0548-8352Baqsimi NDC record
- NDC 85766-212Baqsimi NDC record