Details for New Drug Application (NDA): 215430
✉ Email this page to a colleague
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 twenty 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.
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: | 120 |
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.
Pharmacology for NDA: 215430
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: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 105MG;45MG | ||||
| Approval Date: | Aug 18, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | 10,058,518 | Patent Expiration: | Nov 5, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER | ||||||||
| Patent: | 10,064,857 | Patent Expiration: | Nov 5, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DEXTROMETHORPHAN AND BUPROPION IN COMBINATION TO TREAT MAJOR DEPRESSIVE DISORDER | ||||||||
Complete Access Available with Subscription
