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Last Updated: December 24, 2024

Details for New Drug Application (NDA): 217388


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NDA 217388 describes WAINUA (AUTOINJECTOR), which is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the WAINUA (AUTOINJECTOR) profile page.

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:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)
Approval Date:Dec 21, 2023TE: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:10,683,499Patent Expiration:Aug 25, 2034Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.