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Last Updated: October 12, 2024

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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 eight patents protecting this drug.

This drug has two hundred and eighteen patent family members in forty-five 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 was eligible for patent challenges on April 17, 2024.

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:218
US Patents:8
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 59
Clinical Trials: 17
Patent Applications: 93
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 Loss of Exclusivity (LOE) 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
RemeGen Co., Ltd.Phase 1/Phase 2
National Cancer Institute (NCI)Phase 1
Jonathan RiessPhase 1

See all TUKYSA clinical trials

US Patents and Regulatory Information for TUKYSA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUKYSA is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Treatment of HER2 positive cancers
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: COMBINATION TREATMENT WITH TUCATINIB AND TRASTUZUMAB OF ADULTS WITH RAS WILD-TYPE HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING PREVIOUS TREATMENT AS CLAIMED


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: COMBINATION TREATMENT WITH TUCATINIB AND TRASTUZUMAB OF ADULTS WITH RAS WILD-TYPE HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING PREVIOUS TREATMENT AS CLAIMED


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: COMBINATION TREATMENT WITH TUCATINIB AND TRASTUZUMAB OF ADULTS WITH RAS WILD-TYPE HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING PREVIOUS TREATMENT AS CLAIMED

Quinazoline analogs as receptor tyrosine kinase inhibitors
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dispersions of a ERB2 (HER2) inhibitor
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 METASTATIC SETTING
Exclusivity Expiration: ⤷  Sign Up

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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
Exclusivity Expiration: ⤷  Sign Up

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
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-001 Apr 17, 2020 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Seagen TUKYSA tucatinib TABLET;ORAL 213411-002 Apr 17, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
>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
Patent: Solid dispersions of a Erb2 (HER2) inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 17210499
Patent: SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

Patent: 19200243
Patent: SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2014009092
Patent: dispersão sólida
Estimated Expiration: ⤷  Sign Up

Patent: 2020010643
Patent: Dispersão sólida, composições farmacêuticas compreendendo a referida dispersão, usos das composições farmacêuticas e processo de preparação de uma dispersão sólida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 52058
Patent: DISPERSION SOLIDE (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

Patent: 14454
Patent: DISPERSION SOLIDE DE N4-(4-([1,2,4]TRIAZOLO[1,5-A]PYRIDIN-7-YLOXY)-3-METHYLPHENYL)-N6-(4,4-DIMETHYL-4,5-DIHYDROOXAZOL-2-YL)QUINAZOLINE-4,6-DIAMINE (A SOLID DISPERSION OF N4-(4-([1,2,4]TRIAZOLO[1,5-.ALPHA.]PYRIDIN-7-YLOXY)-3-METHYLPHENYL)-N6-(4,4-DIMETHYL-4,5-DIHYDROOXAZOL-2-YL)QUINAZOLINE-4,6-DIAMINE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 14000930
Patent: Dispersion solida que comprende n4-(4-([1,2,4]triazolo-[1,5-a]piridina-7-iloxi)-3-metilfenil)-n6-(4,4-dimetil-4,5-dihidrooxazol-2-il)quinazolina-4,6-diamina y un polimero de dispersion; proceso de preparacion; composicion farmaceutica; uso en el tratamiento del cancer de mama, gastrico, colorectal, pancreatico, entre otros.
Estimated Expiration: ⤷  Sign Up

China

Patent: 3998023
Patent: Solid dispersions of a ErbB2 (HER2) inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 8498465
Patent: ErbB2(HER2)抑制剂的固态分散体 (Solid dispersions of a Erb2 (HER2) inhibitor)
Estimated Expiration: ⤷  Sign Up

Patent: 4886853
Patent: ErbB2(HER2)抑制剂的固态分散体 (Solid dispersions of ErbB2 (HER2) inhibitors)
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 60547
Patent: Dispersión sólida de un inhibidor erb2 (her2)
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140228
Patent: DISPERSIÓN SÓLIDA
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0171578
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 19837
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 65990
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 65990
Patent: DISPERSION SOLIDE (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 35247
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 2103
Patent: דיספרסיה מוצקה המכילה 4n-)4-([4.2.1]טריאזולו[a5,1]פירידין-7-אילאוקסי-3-מתילפניל)-n6 - (4,4-דימתיל-5,4-דיהידרוקסואוקסאזול-2-איל)קיוונאזולין-6,4-דיאמין ופולימר מבדר, תהליך להכנתה ותכשיר רוקחות המכיל אותה (Solid dispersions of a erb2 (her2) inhibitor)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 44514
Estimated Expiration: ⤷  Sign Up

Patent: 14528484
Patent: 固体分散体
Estimated Expiration: ⤷  Sign Up

Patent: 16027062
Patent: 固体分散体 (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 65990
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 9072
Patent: SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 3970
Patent: DISPERSION SOLIDA. (SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR.)
Estimated Expiration: ⤷  Sign Up

Patent: 14004551
Patent: DISPERSION SOLIDA. (SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 913
Patent: ČVRSTA DISPERZIJA (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 4942
Patent: Solid dispersions of a erb2 (her2) inhibitor
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 21029
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 65990
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 65990
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 48448
Patent: ТВЕРДАЯ ДИСПЕРСИЯ (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

Patent: 14119283
Patent: ТВЕРДАЯ ДИСПЕРСИЯ
Estimated Expiration: ⤷  Sign Up

Patent: 18107710
Patent: ТВЕРДАЯ ДИСПЕРСИЯ
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 608
Patent: ČVRSTA DISPERZIJA (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201401459Y
Patent: SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 65990
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1606123
Patent: PHARMACEUTICAL COMPOSITIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2000312
Estimated Expiration: ⤷  Sign Up

Patent: 140075798
Patent: SOLID DISPERSIONS OF A ERB2 (HER2) INHIBITOR
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 50608
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 94769
Estimated Expiration: ⤷  Sign Up

Patent: 22189
Estimated Expiration: ⤷  Sign Up

Patent: 88733
Estimated Expiration: ⤷  Sign Up

Patent: 1330876
Patent: Solid dispersion
Estimated Expiration: ⤷  Sign Up

Patent: 1728323
Patent: Solid dispersion
Estimated Expiration: ⤷  Sign Up

Patent: 2131902
Patent: Solid dispersion
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 1383
Patent: ТВЕРДА ДИСПЕРСІЯ (SOLID DISPERSION)
Estimated Expiration: ⤷  Sign Up

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
Spain 2650608 ⤷  Sign Up
South Korea 102490961 ⤷  Sign Up
Poland 2765990 ⤷  Sign Up
European Patent Office 2827900 DISPERSION SOLIDE AMORPHE POUR SON UTILISATION DANS LE TRAITEMENT DU CANCER DU CERVEAU (AMORPHOUS SOLID DISPERSION FOR USE IN THE TREATMENT OF BRAIN CANCER) ⤷  Sign Up
South Africa 201606123 PHARMACEUTICAL COMPOSITIONS OF A ERB2 (HER2) INHIBITOR ⤷  Sign Up
Japan 5134548 ⤷  Sign Up
Australia 2022241509 Treatment of HER2 positive cancers ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TUKYSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1971601 CA 2021 00025 Denmark ⤷  Sign Up PRODUCT NAME: TUCATINIB, EVENTUELT I FORM AF ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF; NAT. REG. NO/DATE: EU/1/20/1526 20210212; FIRST REG. NO/DATE: CH 67798 20200507
1971601 27/2021 Austria ⤷  Sign Up PRODUCT NAME: TUCATINIB; REGISTRATION NO/DATE: EU/1/20/1526 (MITTEILUNG) 20210212
1971601 301113 Netherlands ⤷  Sign Up PRODUCT NAME: TUCATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; REGISTRATION NO/DATE: 67798 20200507
1971601 PA2021516,C1971601 Lithuania ⤷  Sign Up PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601 122021000042 Germany ⤷  Sign Up PRODUCT NAME: TUCATINIB UND SEINE PHYSIOLOGISCH VERTRAEGLICHEN SALZE UND SOLVATE; REGISTRATION NO/DATE: EU/1/20/1526 20210211
1971601 C202130042 Spain ⤷  Sign Up 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 2190026-1 Sweden ⤷  Sign Up PRODUCT NAME: TUCATINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE; NAT. REG. NO/DATE: EU/20/1526 20210212; FIRST REG.: CH 67798 20200507
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.