Details for New Drug Application (NDA): 218709
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NDA 218709 describes XOLREMDI, which is a drug marketed by X4 Pharms and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the XOLREMDI profile page.
The generic ingredient in XOLREMDI is mavorixafor. One supplier is listed for this compound. Additional details are available on the mavorixafor profile page.
The generic ingredient in XOLREMDI is mavorixafor. One supplier is listed for this compound. Additional details are available on the mavorixafor profile page.
Summary for 218709
| Tradename: | XOLREMDI |
| Applicant: | X4 Pharms |
| Ingredient: | mavorixafor |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218709
Generic Entry Date for 218709*:
Constraining patent/regulatory exclusivity:
TO INCREASE THE NUMBER OF CIRCULATING MATURE NEUTROPHILS AND LYMPHOCYTES IN PATIENTS 12 YEARS OF AGE AND OLDER WITH WHIM SYNDROME (WARTS, HYPOGAMMAGLOBULINEMIA, INFECTIONS AND MYELOKATHEXIS) Dosage:
CAPSULE;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.
Suppliers and Packaging for NDA: 218709
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| XOLREMDI | mavorixafor | CAPSULE;ORAL | 218709 | NDA | X4 Pharmaceuticals, Inc. | 83296-100 | 83296-100-12 | 120 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-12) |
| XOLREMDI | mavorixafor | CAPSULE;ORAL | 218709 | NDA | X4 Pharmaceuticals, Inc. | 83296-100 | 83296-100-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (83296-100-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 26, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 26, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Apr 26, 2031 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE THE NUMBER OF CIRCULATING MATURE NEUTROPHILS AND LYMPHOCYTES IN PATIENTS 12 YEARS OF AGE AND OLDER WITH WHIM SYNDROME (WARTS, HYPOGAMMAGLOBULINEMIA, INFECTIONS AND MYELOKATHEXIS) | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 11, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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