Niraparib Tosylate Global Patent Coverage & Expiry Overview

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It is formulated by 2 pharmaceutical companies such as GLAXOSMITHKLINE, JANSSEN BIOTECH. It is marketed under 2 brand names, including ZEJULA, AKEEGA. Available in 5 different strengths, such as EQ 100MG BASE, EQ 200MG BASE, EQ 300MG BASE and others, 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":"36742","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"926ec6e88a4a4e729f31","publication_number":"US8143241B2","cleaned_patent_number":"8143241","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-12","publication_date":"2012-03-27","legal_status":"Granted"} US8143241B2 27 Mar, 2012 Granted 12 Aug, 2027
{"application_id":"36741","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"926ec6e88a4a4e729f31","publication_number":"US8071579B2","cleaned_patent_number":"8071579","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-12","publication_date":"2011-12-06","legal_status":"Granted"} US8071579B2 06 Dec, 2011 Granted 12 Aug, 2027
{"application_id":"39763","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"36df53f8d5244870a6dd","publication_number":"US8436185B2","cleaned_patent_number":"8436185","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-24","publication_date":"2013-05-07","legal_status":"Granted"} US8436185B2 Molecular 07 May, 2013 Granted 24 Apr, 2029
{"application_id":"39781","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"6a13c9e41c6e46e8aabf","publication_number":"US8071623B2","cleaned_patent_number":"8071623","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-27","publication_date":"2011-12-06","legal_status":"Granted"} US8071623B2 Molecular Formulation 06 Dec, 2011 Granted 27 Mar, 2031
{"application_id":"35804","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"ff530a092cee43339847","publication_number":"US8859562B2","cleaned_patent_number":"8859562","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-08-04","publication_date":"2014-10-14","legal_status":"Granted"} US8859562B2 14 Oct, 2014 Granted 04 Aug, 2031
{"application_id":"111544","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"db49ef0a362b43fda4ed","publication_number":"US11992486B2","cleaned_patent_number":"11992486","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-28","publication_date":"2024-05-28","legal_status":"Granted"} US11992486B2 28 May, 2024 Granted 28 Jul, 2037
{"application_id":"30253","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"db49ef0a362b43fda4ed","publication_number":"US11207311B2","cleaned_patent_number":"11207311","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-28","publication_date":"2021-12-28","legal_status":"Granted"} US11207311B2 28 Dec, 2021 Granted 28 Jul, 2037
{"application_id":"111228","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"db49ef0a362b43fda4ed","publication_number":"US11986468B2","cleaned_patent_number":"11986468","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-28","publication_date":"2024-05-21","legal_status":"Granted"} US11986468B2 21 May, 2024 Granted 28 Jul, 2037
{"application_id":"112892","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"db49ef0a362b43fda4ed","publication_number":"US11986469B2","cleaned_patent_number":"11986469","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-07-28","publication_date":"2024-05-21","legal_status":"Granted"} US11986469B2 21 May, 2024 Granted 28 Jul, 2037
{"application_id":"37991","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"c5f876a72bbc4d87a4fd","publication_number":"US11091459B2","cleaned_patent_number":"11091459","drug_product_flag":"Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-03-27","publication_date":"2021-08-17","legal_status":"Granted"} US11091459B2 Formulation 17 Aug, 2021 Granted 27 Mar, 2038
{"application_id":"37992","ingredient":"ABIRATERONE ACETATE; NIRAPARIB TOSYLATE","trade_name":"AKEEGA","family_id":"c5f876a72bbc4d87a4fd","publication_number":"US11673877B2","cleaned_patent_number":"11673877","drug_product_flag":"Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-03-27","publication_date":"2023-06-13","legal_status":"Granted"} US11673877B2 Formulation 13 Jun, 2023 Granted 27 Mar, 2038
{"application_id":"116946","ingredient":"NIRAPARIB TOSYLATE","trade_name":"ZEJULA","family_id":"0cd1bb9280ba4024bd71","publication_number":"US11730725B2","cleaned_patent_number":"11730725","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-01-25","publication_date":"2023-08-22","legal_status":"Granted"} US11730725B2 Formulation 22 Aug, 2023 Granted 25 Jan, 2039

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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