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

Baqsimi products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
powder, nasal3MGMarketed (Rx)None0None

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

Patents listed for Baqsimi
PatentExpiresCoversUse codeNDA
10213487February 16, 2036Drug productU-2604210134
12370241February 16, 2036Drug productU-2604210134
10765602September 23, 2039Drug productNone210134

Baqsimi exclusivity

Exclusivity listed for Baqsimi
CodeMeaningExpiresNDA
NPPNew patient populationMarch 17, 2028210134

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.

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