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Last Updated: June 16, 2025

Details for New Drug Application (NDA): 211371


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NDA 211371 describes ZULRESSO, which is a drug marketed by Sage Therap and is included in one NDA. There are eight patents protecting this drug. Additional details are available on the ZULRESSO profile page.

The generic ingredient in ZULRESSO is brexanolone. Additional details are available on the brexanolone profile page.
Summary for 211371
Tradename:ZULRESSO
Applicant:Sage Therap
Ingredient:brexanolone
Patents:8
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211371
Generic Entry Date for 211371*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS

*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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jun 17, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 16, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:10,117,951Patent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:10,251,894Patent Expiration:Nov 27, 2033Product 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.