Details for New Drug Application (NDA): 211371

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

The generic ingredient in ZULRESSO is brexanolone. One supplier is listed for this compound. 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

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.

Pharmacology for NDA: 211371

Mechanism of Action

GABA A Receptor Positive Modulators

Suppliers and Packaging for NDA: 211371

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZULRESSO	brexanolone	SOLUTION;INTRAVENOUS	211371	NDA	Sage Therapeutics, Inc.	72152-547	72152-547-20	1 VIAL, SINGLE-DOSE in 1 CARTON (72152-547-20) / 20 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	100MG/20ML (5MG/ML)
Approval Date:	Jun 17, 2019	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jun 17, 2024
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Jun 16, 2025
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Patent:		Patent Expiration:	Mar 13, 2029	Product Flag?	Y	Substance Flag?		Delist Request?

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