Zanubrutinib Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as BEONE MEDICINES USA. It is marketed under 1 brand name, including BRUKINSA. Available in 2 different strengths, such as 80MG, 160MG, and administered through 2 routes including CAPSULE;ORAL, TABLET;ORAL.

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Sourcing & Feasibility

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

NDA (New Drug Application) ANDA (Generic Application)

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US Orange Book Patents Expiration Timeline

Key expiration dates for US patents covering this ingredient

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Orange Book Drug Strengths

Latest drug strengths approved by FDA

Strength Route of Administration Companies Latest Approval Date

Orange Book Patents

Patents approved by the FDA for the ingredient

Patent Number Publication Date Legal Status Patent Expiry Date
{"application_id":"46348","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"bf9ed8bdf90d45cea1cf","publication_number":"US10570139B2","cleaned_patent_number":"10570139","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-22","publication_date":"2020-02-25","legal_status":"Granted"} US10570139B2 25 Feb, 2020 Granted 22 Apr, 2034
{"application_id":"46349","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"bf9ed8bdf90d45cea1cf","publication_number":"US11142528B2","cleaned_patent_number":"11142528","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-22","publication_date":"2021-10-12","legal_status":"Granted"} US11142528B2 Formulation 12 Oct, 2021 Granted 22 Apr, 2034
{"application_id":"46320","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"bf9ed8bdf90d45cea1cf","publication_number":"US9447106B2","cleaned_patent_number":"9447106","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-22","publication_date":"2016-09-20","legal_status":"Granted"} US9447106B2 Molecular Formulation 20 Sep, 2016 Granted 22 Apr, 2034
{"application_id":"122581","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"92486740ddc34cf2a4fa","publication_number":"US11970500B2","cleaned_patent_number":"11970500","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-15","publication_date":"2024-04-30","legal_status":"Granted"} US11970500B2 30 Apr, 2024 Granted 15 Aug, 2037
{"application_id":"105222","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"cc0782889dc845bf88e0","publication_number":"US11591340B2","cleaned_patent_number":"11591340","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-15","publication_date":"2023-02-28","legal_status":"Granted"} US11591340B2 28 Feb, 2023 Granted 15 Aug, 2037
{"application_id":"111003","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"cc0782889dc845bf88e0","publication_number":"US11851437B2","cleaned_patent_number":"11851437","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-15","publication_date":"2023-12-26","legal_status":"Granted"} US11851437B2 Molecular Formulation 26 Dec, 2023 Granted 15 Aug, 2037
{"application_id":"108222","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"cc0782889dc845bf88e0","publication_number":"US11884674B2","cleaned_patent_number":"11884674","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-15","publication_date":"2024-01-30","legal_status":"Granted"} US11884674B2 30 Jan, 2024 Granted 15 Aug, 2037
{"application_id":"27515","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"cc0782889dc845bf88e0","publication_number":"US10927117B2","cleaned_patent_number":"10927117","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-08-15","publication_date":"2021-02-23","legal_status":"Granted"} US10927117B2 Molecular Formulation 23 Feb, 2021 Granted 15 Aug, 2037
{"application_id":"1735","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"9db7dd55e02d4e90a2cc","publication_number":"US11701357B2","cleaned_patent_number":"11701357","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-06-24","publication_date":"2023-07-18","legal_status":"Granted"} US11701357B2 18 Jul, 2023 Granted 24 Jun, 2039
{"application_id":"117276","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"aa3a212926c74d0dba32","publication_number":"US20240075039A1","cleaned_patent_number":"12233069","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-06-10","publication_date":"2024-03-07","legal_status":"Granted"} US12233069B2 Formulation 07 Mar, 2024 Granted 10 Jun, 2040
{"application_id":"121587","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"06f006e55a254425b80c","publication_number":"US11911386B2","cleaned_patent_number":"11911386","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-19","publication_date":"2024-02-27","legal_status":"Granted"} US11911386B2 27 Feb, 2024 Granted 19 Jan, 2043
{"application_id":"121622","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"6d441638ada64144bbe8","publication_number":"US11896596B2","cleaned_patent_number":"11896596","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-19","publication_date":"2024-02-13","legal_status":"Granted"} US11896596B2 13 Feb, 2024 Granted 19 Jan, 2043
{"application_id":"117091","ingredient":"ZANUBRUTINIB","trade_name":"BRUKINSA","family_id":"06f006e55a254425b80c","publication_number":"US11786531B1","cleaned_patent_number":"11786531","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-19","publication_date":"2023-10-17","legal_status":"Granted"} US11786531B2 17 Oct, 2023 Granted 19 Jan, 2043

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

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.

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