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 one supplier. 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. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dasiglucagon hydrochloride profile page.
The generic ingredient in ZEGALOGUE (AUTOINJECTOR) is dasiglucagon hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the dasiglucagon hydrochloride profile page.
Summary for 214231
| Tradename: | ZEGALOGUE (AUTOINJECTOR) |
| Applicant: | Zealand Pharma |
| Ingredient: | dasiglucagon hydrochloride |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214231
Generic Entry Date for 214231*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SOLUTION;SUBCUTANEOUS |
*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 Action | Glucagon Receptor Agonists |
| Physiological Effect | Increased 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 (AUTOINJECTOR) | 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 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML) | ||||
| Approval Date: | Mar 22, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 18, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 10,442,847 | Patent Expiration: | Mar 22, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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