Valbenazine Tosylate Global Patent Coverage & Expiry Overview

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It is formulated by 3 pharmaceutical companies such as NEUROCRINE, LUPIN LTD, ZYDUS LIFESCIENCES. It is marketed under 3 brand names, including INGREZZA, VALBENAZINE TOSYLATE, INGREZZA SPRINKLE. Available in 3 different strengths, such as EQ 40MG BASE, EQ 80MG BASE, EQ 60MG BASE, and administered through 1 route including CAPSULE;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":"48328","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"7936ed861b334063b653","publication_number":"US8357697B2","cleaned_patent_number":"8357697","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2013-01-22","legal_status":"Granted"} US8357697B2 22 Jan, 2013 Granted 08 Nov, 2027
{"application_id":"48344","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"7936ed861b334063b653","publication_number":"US8039627B2","cleaned_patent_number":"8039627","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-11","publication_date":"2011-10-18","legal_status":"Granted"} US8039627B2 Molecular Formulation 18 Oct, 2011 Granted 11 Apr, 2031
{"application_id":"48321","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"e0bc7f821de443aa93da","publication_number":"US10851103B2","cleaned_patent_number":"10851103","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2020-12-01","legal_status":"Granted"} US10851103B2 Molecular Formulation 01 Dec, 2020 Granted 28 Oct, 2036
{"application_id":"48322","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"e0bc7f821de443aa93da","publication_number":"US10851104B2","cleaned_patent_number":"10851104","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2020-12-01","legal_status":"Granted"} US10851104B2 Molecular 01 Dec, 2020 Granted 28 Oct, 2036
{"application_id":"48290","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"e0bc7f821de443aa93da","publication_number":"US10065952B2","cleaned_patent_number":"10065952","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2018-09-04","legal_status":"Granted"} US10065952B2 Molecular Formulation 04 Sep, 2018 Granted 28 Oct, 2036
{"application_id":"48320","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"e0bc7f821de443aa93da","publication_number":"US10844058B2","cleaned_patent_number":"10844058","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-10-28","publication_date":"2020-11-24","legal_status":"Patented case"} US10844058B2 Molecular Formulation 24 Nov, 2020 Patented case 28 Oct, 2036
{"application_id":"48475","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"83887c2142ef44498e23","publication_number":"US10906902B2","cleaned_patent_number":"10906902","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-22","publication_date":"2021-02-02","legal_status":"Granted"} US10906902B2 Molecular Formulation 02 Feb, 2021 Granted 22 Dec, 2036
{"application_id":"48491","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"83887c2142ef44498e23","publication_number":"US10919892B2","cleaned_patent_number":"10919892","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-22","publication_date":"2021-02-16","legal_status":"Granted"} US10919892B2 Molecular Formulation 16 Feb, 2021 Granted 22 Dec, 2036
{"application_id":"48490","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"83887c2142ef44498e23","publication_number":"US10906903B2","cleaned_patent_number":"10906903","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-12-22","publication_date":"2021-02-02","legal_status":"Granted"} US10906903B2 Molecular Formulation 02 Feb, 2021 Granted 22 Dec, 2036
{"application_id":"48348","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US10874648B2","cleaned_patent_number":"10874648","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2020-12-29","legal_status":"Granted"} US10874648B2 29 Dec, 2020 Granted 10 Oct, 2037
{"application_id":"48395","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US10912771B1","cleaned_patent_number":"10912771","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2021-02-09","legal_status":"Patented case"} US10912771B2 09 Feb, 2021 Patented case 10 Oct, 2037
{"application_id":"48397","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US10993941B2","cleaned_patent_number":"10993941","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2021-05-04","legal_status":"Granted"} US10993941B2 04 May, 2021 Granted 10 Oct, 2037
{"application_id":"48398","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US11040029B2","cleaned_patent_number":"11040029","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2021-06-22","legal_status":"Granted"} US11040029B2 22 Jun, 2021 Granted 10 Oct, 2037
{"application_id":"48401","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US11439629B2","cleaned_patent_number":"11439629","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2022-09-13","legal_status":"Granted"} US11439629B2 13 Sep, 2022 Granted 10 Oct, 2037
{"application_id":"48413","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"287d2e4b0f1a4851a22f","publication_number":"US10857148B2","cleaned_patent_number":"10857148","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2020-12-08","legal_status":"Granted"} US10857148B2 08 Dec, 2020 Granted 10 Oct, 2037
{"application_id":"48394","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US10857137B2","cleaned_patent_number":"10857137","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2020-12-08","legal_status":"Patented case"} US10857137B2 08 Dec, 2020 Patented case 10 Oct, 2037
{"application_id":"48396","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"c2e6cbd087554d8ea1b1","publication_number":"US10952997B2","cleaned_patent_number":"10952997","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-10","publication_date":"2021-03-23","legal_status":"Granted"} US10952997B2 23 Mar, 2021 Granted 10 Oct, 2037
{"application_id":"48469","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"93dd6f608d6e488a9199","publication_number":"US11311532B2","cleaned_patent_number":"11311532","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-18","publication_date":"2022-04-26","legal_status":"Granted"} US11311532B2 Formulation 26 Apr, 2022 Granted 18 Sep, 2038
{"application_id":"48457","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"93dd6f608d6e488a9199","publication_number":"US11026939B2","cleaned_patent_number":"11026939","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-18","publication_date":"2021-06-08","legal_status":"Granted"} US11026939B2 Formulation 08 Jun, 2021 Granted 18 Sep, 2038
{"application_id":"48424","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"287d2e4b0f1a4851a22f","publication_number":"US11654142B2","cleaned_patent_number":"11654142","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-11-14","publication_date":"2023-05-23","legal_status":"Granted"} US11654142B2 23 May, 2023 Granted 14 Nov, 2038
{"application_id":"48438","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"bc78c5cbb22941bbb331","publication_number":"US11026931B2","cleaned_patent_number":"11026931","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-14","publication_date":"2021-06-08","legal_status":"Granted"} US11026931B2 08 Jun, 2021 Granted 14 Aug, 2039
{"application_id":"48427","ingredient":"VALBENAZINE TOSYLATE","trade_name":"INGREZZA","family_id":"2e6086f41e6c4825a1a8","publication_number":"US10940141B1","cleaned_patent_number":"10940141","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-10","publication_date":"2021-03-09","legal_status":"Granted"} US10940141B2 09 Mar, 2021 Granted 10 Aug, 2040

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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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