TUKYSA Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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
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 |


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
Sponsor | Phase |
---|---|
Jonsson Comprehensive Cancer Center | Phase 1/Phase 2 |
Sarah Sammons, MD | Phase 2 |
Criterium, Inc. | Phase 1/Phase 2 |
Pharmacology for TUKYSA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for TUKYSA
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 |