Details for New Drug Application (NDA): 213411
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NDA 213411 describes TUKYSA, which is a drug marketed by Seagen and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the TUKYSA profile page.
The generic ingredient in TUKYSA is tucatinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tucatinib profile page.
The generic ingredient in TUKYSA is tucatinib. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the tucatinib profile page.
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213411
Generic Entry Date for 213411*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY 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: 213411
Suppliers and Packaging for NDA: 213411
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TUKYSA | tucatinib | TABLET;ORAL | 213411 | NDA | SEAGEN INC. | 51144-001 | 51144-001-60 | 60 TABLET in 1 BOTTLE (51144-001-60) |
| TUKYSA | tucatinib | TABLET;ORAL | 213411 | NDA | SEAGEN INC. | 51144-002 | 51144-002-12 | 120 TABLET in 1 BOTTLE (51144-002-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Apr 17, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 17, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR USE IN COMBINATION WITH TRASTUZUMAB AND CAPECITABINE FOR TREATMENT OF ADULT PATIENTS WITH METASTATIC HER2-POSITIVE BREAST CANCER AND BRAIN METASTASES, WHO HAVE RECEIVED ONE OR MORE PRIOR ANTI-HER2-BASED REGIMENS IN THE METASTATIC SETTING | ||||||||
| Regulatory Exclusivity Expiration: | Jan 19, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY | ||||||||
| Regulatory Exclusivity Expiration: | Jan 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | TUCATINIB IN COMBINATION WITH TRASTUZUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE, UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY | ||||||||
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