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Last Updated: June 21, 2024

Details for New Drug Application (NDA): 214231

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NDA 214231 describes ZEGALOGUE (AUTOINJECTOR), which is a drug marketed by Zealand Pharma 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 ZEGALOGUE (AUTOINJECTOR) profile page.

The generic ingredient in ZEGALOGUE (AUTOINJECTOR) is dasiglucagon hydrochloride. Two suppliers are listed for this compound. Additional details are available on the dasiglucagon hydrochloride profile page.
Summary for 214231
Applicant:Zealand Pharma
Ingredient:dasiglucagon hydrochloride
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214231
Generic Entry Date for 214231*:
Constraining patent/regulatory exclusivity:

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 214231
Mechanism of ActionGlucagon Receptor Agonists
Physiological EffectIncreased Glycogenolysis
Suppliers and Packaging for NDA: 214231
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZEGALOGUE dasiglucagon hydrochloride SOLUTION;SUBCUTANEOUS 214231 NDA Novo Nordisk 0169-1912 0169-1912-01 1 CONTAINER in 1 PACKAGE (0169-1912-01) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS
ZEGALOGUE dasiglucagon hydrochloride SOLUTION;SUBCUTANEOUS 214231 NDA Novo Nordisk 0169-1912 0169-1912-02 2 PACKAGE in 1 CARTON (0169-1912-02) / 1 CONTAINER in 1 PACKAGE (0169-1912-12) / 1 SYRINGE, GLASS in 1 CONTAINER / .6 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)
Approval Date:Mar 22, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 22, 2026
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Feb 3, 2035Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Sign UpPatent Expiration:Jan 6, 2034Product Flag?Substance Flag?Delist Request?

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