Details for New Drug Application (NDA): 217159

NDA 217159 describes APHEXDA, which is a drug marketed by Biolinerx Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the APHEXDA profile page.

The generic ingredient in APHEXDA is motixafortide acetate. One supplier is listed for this compound. Additional details are available on the motixafortide acetate profile page.

Summary for 217159

Tradename:	APHEXDA
Applicant:	Biolinerx Ltd
Ingredient:	motixafortide acetate
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 217159

Constraining patent/regulatory exclusivity:

TO MOBILIZE HEMATOPOIETIC STEM CELLS TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Dosage:

POWDER;SUBCUTANEOUS

^*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: 217159

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	BioLineRx USA Inc	82737-073	82737-073-01	1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	POWDER;SUBCUTANEOUS			Strength	EQ 62MG BASE/VIAL
Approval Date:	Sep 8, 2023	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 8, 2028
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Sep 8, 2030
Regulatory Exclusivity Use:	TO MOBILIZE HEMATOPOIETIC STEM CELLS TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Complete Access Available with Subscription