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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 215430


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NDA 215430 describes AUVELITY, which is a drug marketed by Axsome and is included in one NDA. It is available from one supplier. There are one hundred and nineteen patents protecting this drug. Additional details are available on the AUVELITY profile page.

The generic ingredient in AUVELITY is bupropion hydrochloride; dextromethorphan hydrobromide. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the bupropion hydrochloride; dextromethorphan hydrobromide profile page.
Summary for 215430
Tradename:AUVELITY
Applicant:Axsome
Ingredient:bupropion hydrochloride; dextromethorphan hydrobromide
Patents:119
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215430
Generic Entry Date for 215430*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;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.

Suppliers and Packaging for NDA: 215430
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430 NDA Axsome Therapeutics, Inc. 81968-045 81968-045-14 1 BOTTLE in 1 CARTON (81968-045-14) / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
AUVELITY bupropion hydrochloride; dextromethorphan hydrobromide TABLET, EXTENDED RELEASE;ORAL 215430 NDA Axsome Therapeutics, Inc. 81968-045 81968-045-30 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE (81968-045-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength105MG;45MG
Approval Date:Aug 18, 2022TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 18, 2025
Regulatory Exclusivity Use:NEW PRODUCT
Patent:⤷  Sign UpPatent Expiration:Nov 5, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER
Patent:⤷  Sign UpPatent Expiration:Nov 5, 2034Product Flag?Substance Flag?Delist Request?
Patented Use:DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER

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