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Last Updated: October 7, 2024

Details for New Drug Application (NDA): 217369


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NDA 217369 describes ZURZUVAE, which is a drug marketed by Biogen 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 ZURZUVAE profile page.

The generic ingredient in ZURZUVAE is zuranolone. One supplier is listed for this compound. Additional details are available on the zuranolone profile page.
Summary for 217369
Tradename:ZURZUVAE
Applicant:Biogen Inc
Ingredient:zuranolone
Patents:5
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217369
Generic Entry Date for 217369*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
CAPSULE;ORAL

*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: 217369
Suppliers and Packaging for NDA: 217369
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZURZUVAE zuranolone CAPSULE;ORAL 217369 NDA Biogen MA Inc. 64406-029 64406-029-01 1 BOTTLE in 1 CARTON (64406-029-01) / 14 CAPSULE in 1 BOTTLE
ZURZUVAE zuranolone CAPSULE;ORAL 217369 NDA Biogen MA Inc. 64406-030 64406-030-01 1 BOTTLE in 1 CARTON (64406-030-01) / 14 CAPSULE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength20MG
Approval Date:Oct 31, 2023TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 31, 2028
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:Apr 17, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING POSTPARTUM DEPRESSION
Patent:⤷  Sign UpPatent Expiration:Apr 17, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING POSTPARTUM DEPRESSION

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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.