Details for New Drug Application (NDA): 217159
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NDA 217159 describes APHEXDA, which is a drug marketed by Ayrmid Pharma and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the APHEXDA profile page.
The generic ingredient in APHEXDA is motixafortide acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the motixafortide acetate profile page.
The generic ingredient in APHEXDA is motixafortide acetate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the motixafortide acetate profile page.
Summary for 217159
| Tradename: | APHEXDA |
| Applicant: | Ayrmid Pharma |
| Ingredient: | motixafortide acetate |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217159
Generic Entry 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 | Gamida Cell Inc. | 73441-062 | 73441-062-01 | 1 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS |
| 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 | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 29, 2041 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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