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Last Updated: August 10, 2022

TUKYSA Drug Patent 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 thirty-seven patent family members in thirty-eight 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:137
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 51
Clinical Trials: 10
Patent Applications: 118
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:
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

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

SponsorPhase
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2
Sarah Sammons, MDPhase 2
Criterium, Inc.Phase 1/Phase 2

See all TUKYSA clinical trials

US Patents and Regulatory Information for TUKYSA

TUKYSA is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUKYSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TUKYSA

Quinazoline analogs as receptor tyrosine kinase inhibitors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER

N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid dispersions of a ERB2 (HER2) inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER

N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER

FDA Regulatory Exclusivity protecting TUKYSA

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 METASTIC SETTING
Exclusivity Expiration: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

EU/EMA Drug Approvals for TUKYSA

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Seagen B.V. Tukysa tucatinib EMEA/H/C/005263
Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2‑positive locally advanced or metastatic breast cancer who have received at least 2 prior anti‑HER2 treatment regimens.
Authorised no no no 2021-02-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for TUKYSA

When does loss-of-exclusivity occur for TUKYSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 12322039
Estimated Expiration: See Plans and Pricing

Patent: 17210499
Estimated Expiration: See Plans and Pricing

Patent: 19200243
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014009092
Estimated Expiration: See Plans and Pricing

Patent: 2020010643
Estimated Expiration: See Plans and Pricing

Canada

Patent: 52058
Estimated Expiration: See Plans and Pricing

Patent: 14454
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14000930
Estimated Expiration: See Plans and Pricing

China

Patent: 3998023
Estimated Expiration: See Plans and Pricing

Patent: 8498465
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 60547
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140228
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171578
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19837
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 65990
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 65990
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 35247
Estimated Expiration: See Plans and Pricing

Israel

Patent: 2103
Estimated Expiration: See Plans and Pricing

Japan

Patent: 44514
Estimated Expiration: See Plans and Pricing

Patent: 14528484
Estimated Expiration: See Plans and Pricing

Patent: 16027062
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 65990
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 9072
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3970
Estimated Expiration: See Plans and Pricing

Patent: 14004551
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 913
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 4942
Estimated Expiration: See Plans and Pricing

Norway

Patent: 21029
Estimated Expiration: See Plans and Pricing

Poland

Patent: 65990
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 65990
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 48448
Estimated Expiration: See Plans and Pricing

Patent: 14119283
Estimated Expiration: See Plans and Pricing

Patent: 18107710
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 608
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201401459Y
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 65990
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1606123
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2000312
Estimated Expiration: See Plans and Pricing

Patent: 140075798
Estimated Expiration: See Plans and Pricing

Spain

Patent: 50608
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 94769
Estimated Expiration: See Plans and Pricing

Patent: 22189
Estimated Expiration: See Plans and Pricing

Patent: 1330876
Estimated Expiration: See Plans and Pricing

Patent: 1728323
Estimated Expiration: See Plans and Pricing

Patent: 2131902
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 1383
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TUKYSA around the world.

Country Patent Number Title Estimated Expiration
Croatia P20171578 See Plans and Pricing
Japan 2007502295 See Plans and Pricing
Brazil 122020010643 Dispersão sólida, composições farmacêuticas compreendendo a referida dispersão, usos das composições farmacêuticas e processo de preparação de uma dispersão sólida See Plans and Pricing
Cyprus 1119837 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TUKYSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1971601 301113 Netherlands See Plans and Pricing PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
1971601 LUC00217 Luxembourg See Plans and Pricing PRODUCT NAME: TUCATINIB EVENTUELLEMENT SOUS FORME D'UN SEL OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212
1971601 C202130042 Spain See Plans and Pricing PRODUCT NAME: TUCATINIB, OPCIONALMENTE EN FORMA DE UNA SAL O SOLVATO ACEPTABLE; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211
1971601 122021000042 Germany See Plans and Pricing PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Baxter
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Moodys

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.