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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

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. There is one patent 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. One supplier is listed for this compound. Additional details are available on the glucagon profile page.
Summary for 212097
Tradename:GVOKE PFS
Applicant:Xeris
Ingredient:glucagon
Patents:1
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 212097

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength0.5MG/0.1ML (0.5MG/0.1ML)
Approval Date:Sep 10, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 10, 2022
Regulatory Exclusivity Use:NEW PRODUCT
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
Regulatory Exclusivity Expiration:Sep 10, 2022
Regulatory Exclusivity Use:NEW PRODUCT

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