Details for New Drug Application (NDA): 217564
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NDA 217564 describes FRUZAQLA, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the FRUZAQLA profile page.
The generic ingredient in FRUZAQLA is fruquintinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fruquintinib profile page.
The generic ingredient in FRUZAQLA is fruquintinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fruquintinib profile page.
Summary for 217564
| Tradename: | FRUZAQLA |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | fruquintinib |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217564
Generic Entry Date for 217564*:
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: 217564
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-210 | 63020-210-21 | 1 BOTTLE in 1 CARTON (63020-210-21) / 21 CAPSULE in 1 BOTTLE |
| FRUZAQLA | fruquintinib | CAPSULE;ORAL | 217564 | NDA | Takeda Pharmaceuticals America, Inc. | 63020-225 | 63020-225-21 | 1 BOTTLE in 1 CARTON (63020-225-21) / 21 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
| Approval Date: | Nov 8, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 8, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,519,142 | Patent Expiration: | Sep 7, 2035 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY, ANTI-VEGF THERAPY, AND, IF RAS WILD-TYPE AND MEDICALLY APPROPRIATE, ANTI-EGFR THERAPY | ||||||||
| Patent: | 11,046,674 | Patent Expiration: | Sep 7, 2035 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF PATIENTS WITH METASTATIC COLORECTAL CANCER WHO HAVE BEEN PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY, ANTI-VEGF THERAPY, AND, IF RAS WILD-TYPE AND MEDICALLY APPROPRIATE, ANTI-EGFR THERAPY | ||||||||
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