Details for New Drug Application (NDA): 218944
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NDA 218944 describes REVUFORJ, which is a drug marketed by Syndax and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the REVUFORJ profile page.
The generic ingredient in REVUFORJ is revumenib citrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the revumenib citrate profile page.
The generic ingredient in REVUFORJ is revumenib citrate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the revumenib citrate profile page.
Summary for 218944
| Tradename: | REVUFORJ |
| Applicant: | Syndax |
| Ingredient: | revumenib citrate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218944
Generic Entry Date for 218944*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.
Pharmacology for NDA: 218944
| Mechanism of Action | Menin Inhibitors |
Suppliers and Packaging for NDA: 218944
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REVUFORJ | revumenib citrate | TABLET;ORAL | 218944 | NDA | Syndax Pharmaceuticals, Inc. | 73555-500 | 73555-500-00 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-500-00) |
| REVUFORJ | revumenib citrate | TABLET;ORAL | 218944 | NDA | Syndax Pharmaceuticals, Inc. | 73555-501 | 73555-501-00 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (73555-501-00) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Nov 15, 2024 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 15, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 15, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF RELAPSED OR REFRACTORY ACUTE LYMPHOCYTIC LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER | ||||||||
| Regulatory Exclusivity Expiration: | Nov 15, 2031 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA WITH A LYSINE METHYLTRANSFERASE 2A GENE (KMT2A) TRANSLOCATION IN ADULT AND PEDIATRIC PATIENTS 1 YEAR AND OLDER | ||||||||
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