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 six patents protecting this drug.
This drug has two hundred and nine patent family members in forty-four 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: | 209 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 13 |
Patent Applications: | 124 |
Drug Prices: | Drug price information for TUKYSA |
What excipients (inactive ingredients) are in TUKYSA? | TUKYSA excipients list |
DailyMed Link: | TUKYSA at DailyMed |


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
Sponsor | Phase |
---|---|
SCRI Development Innovations, LLC | Phase 2 |
Spanish Breast Cancer Research Group | Phase 2 |
Criterium, Inc. | 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 six US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUKYSA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: COMBINATION TREATMENT OF COLORECTAL CANCER INCLUDING RAS WILD-TYPE HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING UNRESECTABLE OR METASTATIC COLORECTAL CANCER
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BREAST CANCER INCLUDING HER2 (ERBB2)-POSITIVE OR -OVEREXPRESSING BREAST CANCER
Quinazoline analogs as receptor tyrosine kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid dispersions of a ERB2 (HER2) inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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: ⤷ Try a Trial
Patent: 17210499
Estimated Expiration: ⤷ Try a Trial
Patent: 19200243
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2014009092
Estimated Expiration: ⤷ Try a Trial
Patent: 2020010643
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 52058
Estimated Expiration: ⤷ Try a Trial
Patent: 14454
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 14000930
Estimated Expiration: ⤷ Try a Trial
China
Patent: 3998023
Estimated Expiration: ⤷ Try a Trial
Patent: 8498465
Estimated Expiration: ⤷ Try a Trial
Patent: 4886853
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 60547
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 140228
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0171578
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 19837
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 35247
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 2103
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 44514
Estimated Expiration: ⤷ Try a Trial
Patent: 14528484
Estimated Expiration: ⤷ Try a Trial
Patent: 16027062
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 9072
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 3970
Estimated Expiration: ⤷ Try a Trial
Patent: 14004551
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 913
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 4942
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 21029
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 48448
Estimated Expiration: ⤷ Try a Trial
Patent: 14119283
Estimated Expiration: ⤷ Try a Trial
Patent: 18107710
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 608
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201401459Y
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 65990
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1606123
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2000312
Estimated Expiration: ⤷ Try a Trial
Patent: 140075798
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 50608
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 94769
Estimated Expiration: ⤷ Try a Trial
Patent: 22189
Estimated Expiration: ⤷ Try a Trial
Patent: 88733
Estimated Expiration: ⤷ Try a Trial
Patent: 1330876
Estimated Expiration: ⤷ Try a Trial
Patent: 1728323
Estimated Expiration: ⤷ Try a Trial
Patent: 2131902
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 1383
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
China | 109223791 | 脑癌的治疗 (Treatment of brain cancer) | ⤷ Try a Trial |
Japan | 2010270154 | METHOD FOR PRODUCING N4-PHENYL-QUINAZOLINE-4-AMINE DERIVATIVE, AND INTERMEDIATE THEREOF | ⤷ Try a Trial |
China | 114886853 | ErbB2(HER2)抑制剂的固态分散体 (Solid dispersions of ErbB2 (HER2) inhibitors) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TUKYSA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1971601 | C202130042 | Spain | ⤷ Try a Trial | 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 | C 2021 022 | Romania | ⤷ Try a Trial | PRODUCT NAME: TUCATINIB OPTIONAL SUB FORMA DE SARE ACCEPTABILA FARMACEUTIC SAU SOLVAT; NATIONAL AUTHORISATION NUMBER: EU/1/20/1526; DATE OF NATIONAL AUTHORISATION: 20210211; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1526; DATE OF FIRST AUTHORISATION IN EEA: 20210211 |
1971601 | C20210018 00331 | Estonia | ⤷ Try a Trial | PRODUCT NAME: TUKATINIIB;REG NO/DATE: EU/1/20/1526 12.02.2021 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |