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Last Updated: September 18, 2020

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TUKYSA Drug Profile

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Which patents cover Tukysa, and what generic alternatives are available?

Tukysa is a drug marketed by Seattle Genetics and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and twenty-six patent family members in thirty-six countries.

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

US ANDA Litigation and Generic Entry Outlook for Tukysa

Tukysa will be eligible for patent challenges on April 17, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TUKYSA
Drug patent expirations by year for TUKYSA
Drug Prices for TUKYSA

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Generic Entry Opportunity Date for TUKYSA
Generic Entry Date for TUKYSA*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for TUKYSA

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SponsorPhase
Seattle Genetics, Inc.Phase 1

See all TUKYSA clinical trials

US Patents and Regulatory Information for TUKYSA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Seattle Genetics TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Seattle Genetics TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Seattle Genetics TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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