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Last Updated: June 13, 2021

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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 Seagen 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.

DrugPatentWatch® 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
International Patents:126
US Patents:4
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 46
Clinical Trials: 4
Patent Applications: 56
Drug Prices: Drug price information for TUKYSA
What excipients (inactive ingredients) are in TUKYSA?TUKYSA excipients list
DailyMed Link:TUKYSA at DailyMed
Drug patent expirations by year for TUKYSA
Drug Prices for TUKYSA

See drug prices for TUKYSA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for TUKYSA
Generic Entry Date for TUKYSA*:
Constraining patent/regulatory exclusivity:

*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

Identify potential brand extensions & 505(b)(2) entrants

Breast Cancer Trials, Australia and New ZealandPhase 2
Merck Sharp & Dohme Corp.Phase 2
Merck Sharp & Dohme Corp.Phase 1/Phase 2

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
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes   Get Started Free   Get Started Free Y   Get Started Free
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
>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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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.