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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TUKYSA
*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 |
|---|---|
| RemeGen Co., Ltd. | Phase 1/Phase 2 |
| Jonathan Riess | Phase 1 |
| National Cancer Institute (NCI) | Phase 1 |
Pharmacology for TUKYSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 2C8 Inhibitors Cytochrome P450 3A Inhibitors P-Glycoprotein Inhibitors Tyrosine Kinase Inhibitors |
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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for TUKYSA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
|---|---|---|---|
| Japan | 2009515988 | ⤷ Sign Up | |
| South Korea | 102490961 | ⤷ Sign Up | |
| Slovenia | 2090575 | ⤷ 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 | 2021C/531 | Belgium | ⤷ Sign Up | PRODUCT NAME: TUCATINIB, OPTIONEEL IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT; AUTHORISATION NUMBER AND DATE: EU/1/20/1526 20210212 |
| 1971601 | 132021000000128 | Italy | ⤷ Sign Up | PRODUCT NAME: TUCATINIB OPZIONALMENTE NELLA FORMA DI UN SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE(TUKYSA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1526, 20210212 |
| 1971601 | PA2021516,C1971601 | Lithuania | ⤷ Sign Up | PRODUCT NAME: TUKATINIBAS, PASIRINKTINAI FARMACISKAI PRIIMTINOS DRUSKOS ARBA SOLVATO PAVIDALU; REGISTRATION NO/DATE: EU/1/20/1526 20210211 |
| >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.
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