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 eight patents protecting this drug. Additional details are available on the TUKYSA profile page.

The generic ingredient in TUKYSA is tucatinib. One supplier is listed for this compound. Additional details are available on the tucatinib profile page.

Summary for 213411

Tradename:	TUKYSA
Applicant:	Seagen
Ingredient:	tucatinib
Patents:	8

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 213411

Generic Entry Date for 213411^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Mechanism of Action	Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors

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:	Apr 17, 2025
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
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

Expired US Patents for NDA 213411

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-002	Apr 17, 2020	⤷ Sign Up	⤷ Sign Up
Seagen	TUKYSA	tucatinib	TABLET;ORAL	213411-001	Apr 17, 2020	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.