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Boehringer Ingelheim

Last Updated: June 4, 2023

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. 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
Applicant:Sage Therap
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211371
Generic Entry Date for 211371*:
Constraining patent/regulatory exclusivity:

*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: 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: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
Regulatory Exclusivity Expiration:Jun 16, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try a TrialPatent Expiration:Mar 13, 2029Product Flag?YSubstance Flag?Delist Request?

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Boehringer Ingelheim

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