Details for New Drug Application (NDA): 214759
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NDA 214759 describes GRAFAPEX, which is a drug marketed by Medexus and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the GRAFAPEX profile page.
The generic ingredient in GRAFAPEX is treosulfan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the treosulfan profile page.
The generic ingredient in GRAFAPEX is treosulfan. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the treosulfan profile page.
Summary for 214759
| Tradename: | GRAFAPEX |
| Applicant: | Medexus |
| Ingredient: | treosulfan |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214759
Generic Entry Date for 214759*:
Constraining patent/regulatory exclusivity:
AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML) 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.
Suppliers and Packaging for NDA: 214759
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GRAFAPEX | treosulfan | POWDER;INTRAVENOUS | 214759 | NDA | Medexus Pharma, Inc. | 59137-335 | 59137-335-01 | 1 VIAL in 1 CARTON (59137-335-01) / 1 g in 1 VIAL |
| GRAFAPEX | treosulfan | POWDER;INTRAVENOUS | 214759 | NDA | Medexus Pharma, Inc. | 59137-365 | 59137-365-01 | 1 VIAL in 1 CARTON (59137-365-01) / 5 g in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 1GM/VIAL | ||||
| Approval Date: | Jan 21, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 21, 2032 | ||||||||
| Regulatory Exclusivity Use: | AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH ACUTE MYELOID LEUKEMIA (AML) | ||||||||
| Regulatory Exclusivity Expiration: | Jan 21, 2032 | ||||||||
| Regulatory Exclusivity Use: | AS A PREPARATIVE REGIMEN FOR ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH MYELODYSPLASTIC SYNDROME (MDS) | ||||||||
| Regulatory Exclusivity Expiration: | Jan 21, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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