NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as SEAGEN. It is marketed under 1 brand name, including TUKYSA. Available in 2 different strengths, such as 50MG, 150MG, and administered through 1 route including TABLET;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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Patent Number | Publication Date | Legal Status | Patent Expiry Date | |
|---|---|---|---|---|---|
| {"application_id":"101500","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"617f713600574ad88376","publication_number":"US7452895B2","cleaned_patent_number":"7452895","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-16","publication_date":"2008-11-18","legal_status":"Granted"} | US7452895B2 Molecular Formulation | 18 Nov, 2008 | Granted | 16 Nov, 2025 | |
| {"application_id":"101598","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"c784b6ed29e648b8b3a1","publication_number":"US9693989B2","cleaned_patent_number":"9693989","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-09","publication_date":"2017-07-04","legal_status":"Granted"} | US9693989B2 Formulation | 04 Jul, 2017 | Granted | 09 May, 2027 | |
| {"application_id":"101640","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"c784b6ed29e648b8b3a1","publication_number":"US8648087B2","cleaned_patent_number":"8648087","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-12","publication_date":"2014-02-11","legal_status":"Granted"} | US8648087B2 Molecular Formulation | 11 Feb, 2014 | Granted | 12 Apr, 2031 | |
| {"application_id":"101549","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"dff18622db8b4c568e68","publication_number":"US9457093B2","cleaned_patent_number":"9457093","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-10-12","publication_date":"2016-10-04","legal_status":"Granted"} | US9457093B2 Formulation | 04 Oct, 2016 | Granted | 12 Oct, 2032 | |
| {"application_id":"37389","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"ba222c847c994ae88f11","publication_number":"US11504370B2","cleaned_patent_number":"11504370","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-03-25","publication_date":"2022-11-22","legal_status":"Granted"} | US11504370B2 | 22 Nov, 2022 | Granted | 25 Mar, 2033 | |
| {"application_id":"110705","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"6b2f3b65623b44ec8c0c","publication_number":"US11666572B2","cleaned_patent_number":"11666572","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-27","publication_date":"2023-06-06","legal_status":"Granted"} | US11666572B2 | 06 Jun, 2023 | Granted | 27 Apr, 2038 | |
| {"application_id":"130742","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"","publication_number":"US12048698B2","cleaned_patent_number":"12048698","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-27","publication_date":"2024-07-30","legal_status":"Granted"} | US12048698B2 | 30 Jul, 2024 | Granted | 27 Apr, 2038 | |
| {"application_id":"110693","ingredient":"TUCATINIB","trade_name":"TUKYSA","family_id":"6b2f3b65623b44ec8c0c","publication_number":"US11207324B2","cleaned_patent_number":"11207324","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-27","publication_date":"2021-12-28","legal_status":"Granted"} | US11207324B2 | 28 Dec, 2021 | Granted | 27 Apr, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
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Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.