Details for New Drug Application (NDA): 217388
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The generic ingredient in WAINUA (AUTOINJECTOR) is eplontersen sodium. One supplier is listed for this compound. Additional details are available on the eplontersen sodium profile page.
Summary for 217388
Tradename: | WAINUA (AUTOINJECTOR) |
Applicant: | Astrazeneca Ab |
Ingredient: | eplontersen sodium |
Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217388
Generic Entry Date for 217388*:
Constraining patent/regulatory exclusivity:
TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS 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: 217388
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
WAINUA (AUTOINJECTOR) | eplontersen sodium | SOLUTION;SUBCUTANEOUS | 217388 | NDA | AstraZeneca Pharmaceuticals LP | 0310-9400 | 0310-9400-01 | 45 mg in 1 SYRINGE, GLASS (0310-9400-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML) | ||||
Approval Date: | Dec 21, 2023 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 21, 2028 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Dec 21, 2030 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 25, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patented Use: | TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS |
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