Details for New Drug Application (NDA): 214383
✉ Email this page to a colleague
The generic ingredient in PEPAXTO is melphalan flufenamide hydrochloride. There are twelve drug master file entries for this compound. Additional details are available on the melphalan flufenamide hydrochloride profile page.
Summary for 214383
Tradename: | PEPAXTO |
Applicant: | Oncopeptides Ab |
Ingredient: | melphalan flufenamide hydrochloride |
Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214383
Generic Entry Date for 214383*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;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: | DISCN | Dosage: | POWDER;INTRAVENOUS | Strength | EQ 20MG BASE/VIAL | ||||
Approval Date: | Feb 26, 2021 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Feb 26, 2026 | ||||||||
Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Regulatory Exclusivity Expiration: | Feb 26, 2028 | ||||||||
Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST FOUR PRIOR LINES OF THERAPY AND WHOSE DISEASE IS REFRACTORY TO AT LEAST ONE PROTEASOME INHIBITOR, ONE IMMUNOMODULATORY AGENT, AND ONE CD-38 DIRECTED MONOCLONAL ANTIBODY | ||||||||
Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 25, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? |
Complete Access Available with Subscription