Details for New Drug Application (NDA): 219407
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NDA 219407 describes DAWNZERA (AUTOINJECTOR), which is a drug marketed by Ionis Pharms Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the DAWNZERA (AUTOINJECTOR) profile page.
The generic ingredient in DAWNZERA (AUTOINJECTOR) is donidalorsen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the donidalorsen sodium profile page.
The generic ingredient in DAWNZERA (AUTOINJECTOR) is donidalorsen sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the donidalorsen sodium profile page.
Summary for 219407
| Tradename: | DAWNZERA (AUTOINJECTOR) |
| Applicant: | Ionis Pharms Inc |
| Ingredient: | donidalorsen sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219407
Generic Entry Date for 219407*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 219407
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAWNZERA (AUTOINJECTOR) | donidalorsen sodium | SOLUTION;SUBCUTANEOUS | 219407 | NDA | Ionis Pharmaceuticals Inc. | 71860-103 | 71860-103-01 | 1 SYRINGE, GLASS in 1 CARTON (71860-103-01) / .8 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) | ||||
| Approval Date: | Aug 21, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 21, 2032 | ||||||||
| Regulatory Exclusivity Use: | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 1, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | PROPHYLAXIS TO PREVENT ATTACKS OF HEREDITARY ANGIOEDEMA (HAE) IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 1, 2034 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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