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Last Updated: July 10, 2020

DrugPatentWatch Database Preview

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 seven 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:7
Generic Entry Opportunity 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:RXDosage:SOLUTION;INTRAVENOUSStrength100MG/20ML (5MG/ML)
Approval Date:Jun 17, 2019TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 17, 2024
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:  Start TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 27, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING POSTPARTUM DEPRESSION

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