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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 212097


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NDA 212097 describes GVOKE PFS, which is a drug marketed by Xeris and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the GVOKE PFS profile page.

The generic ingredient in GVOKE PFS is glucagon. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the glucagon profile page.
Summary for 212097
Tradename:GVOKE PFS
Applicant:Xeris
Ingredient:glucagon
Patents:2
Pharmacology for NDA: 212097
Physiological EffectDecreased GI Motility
Decreased GI Smooth Muscle Tone
Decreased Glycolysis
Increased Gluconeogenesis
Increased Glycogenolysis
Medical Subject Heading (MeSH) Categories for 212097
Gastrointestinal Agents
Hormones
Suppliers and Packaging for NDA: 212097
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GVOKE VIALDX glucagon SOLUTION;INTRAVENOUS 212097 NDA American Regent, Inc. 0517-2901 0517-2901-01 1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL
GVOKE HYPOPEN glucagon SOLUTION;SUBCUTANEOUS 212097 NDA American Regent, Inc. 0517-2901 0517-2901-01 1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;SUBCUTANEOUSStrength0.5MG/0.1ML (0.5MG/0.1ML)
Approval Date:Sep 10, 2019TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA
Patent:⤷  Start TrialPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength1MG/0.2ML (1MG/0.2ML)
Approval Date:Sep 10, 2019TE:RLD:Yes
Patent:⤷  Start TrialPatent Expiration:Apr 22, 2036Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF SEVERE HYPOGLYCEMIA

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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