Details for New Drug Application (NDA): 215814
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NDA 215814 describes REZLIDHIA, which is a drug marketed by Rigel Pharms and is included in one NDA. It is available from one supplier. There are fourteen patents protecting this drug. Additional details are available on the REZLIDHIA profile page.
The generic ingredient in REZLIDHIA is olutasidenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the olutasidenib profile page.
The generic ingredient in REZLIDHIA is olutasidenib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the olutasidenib profile page.
Summary for 215814
| Tradename: | REZLIDHIA |
| Applicant: | Rigel Pharms |
| Ingredient: | olutasidenib |
| Patents: | 14 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215814
Generic Entry Date for 215814*:
Constraining patent/regulatory exclusivity:
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: 215814
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REZLIDHIA | olutasidenib | CAPSULE;ORAL | 215814 | NDA | Rigel Pharmaceuticals, Inc. | 71332-005 | 71332-005-01 | 30 CAPSULE in 1 BOTTLE (71332-005-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 150MG | ||||
| Approval Date: | Dec 1, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 1, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 1, 2029 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY ACUTE MYELOID LEUKEMIA (AML) WITH A SUSCEPTIBLE ISOCITRATE DEHYDROGENASE-1 (IDH1) MUTATION AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Patent: | 10,414,752 | Patent Expiration: | Sep 18, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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