Lumateperone Tosylate Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as INTRA-CELLULAR. It is marketed under 1 brand name, including CAPLYTA. Available in 3 different strengths, such as EQ 42MG BASE, EQ 10.5MG BASE, EQ 21MG 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":"35159","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"31696bc87fba442b90de","publication_number":"US10464938B2","cleaned_patent_number":"10464938","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-03-12","publication_date":"2019-11-05","legal_status":"Granted"} US10464938B2 Formulation 05 Nov, 2019 Granted 12 Mar, 2028
{"application_id":"27941","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"db05a1726ce54bf2a6a1","publication_number":"USRE48825E","cleaned_patent_number":"RE48825","drug_product_flag":"-, Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-12","publication_date":"2021-11-23","legal_status":"Granted"} USRE48825E1 Molecular 23 Nov, 2021 Granted 12 Mar, 2029
{"application_id":"36411","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"db05a1726ce54bf2a6a1","publication_number":"US9586960B2","cleaned_patent_number":"9586960","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-12","publication_date":"2017-03-07","legal_status":"Granted"} US9586960B2 Molecular Formulation 07 Mar, 2017 Granted 12 Mar, 2029
{"application_id":"36410","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"db05a1726ce54bf2a6a1","publication_number":"US9199995B2","cleaned_patent_number":"9199995","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-12","publication_date":"2015-12-01","legal_status":"Granted"} US9199995B2 01 Dec, 2015 Granted 12 Mar, 2029
{"application_id":"36607","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"a7f49907e6344ea0badd","publication_number":"US9616061B2","cleaned_patent_number":"9616061","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-27","publication_date":"2017-04-11","legal_status":"Granted"} US9616061B2 Formulation 11 Apr, 2017 Granted 27 May, 2029
{"application_id":"36608","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"a7f49907e6344ea0badd","publication_number":"US10117867B2","cleaned_patent_number":"10117867","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-27","publication_date":"2018-11-06","legal_status":"Granted"} US10117867B2 06 Nov, 2018 Granted 27 May, 2029
{"application_id":"36606","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"a7f49907e6344ea0badd","publication_number":"US9168258B2","cleaned_patent_number":"9168258","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-27","publication_date":"2015-10-27","legal_status":"Granted"} US9168258B2 Formulation 27 Oct, 2015 Granted 27 May, 2029
{"application_id":"36409","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"db05a1726ce54bf2a6a1","publication_number":"US8648077B2","cleaned_patent_number":"8648077","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-01","publication_date":"2014-02-11","legal_status":"Granted"} US8648077B2 Molecular Formulation 11 Feb, 2014 Granted 01 Dec, 2029
{"application_id":"36605","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"a7f49907e6344ea0badd","publication_number":"US8598119B2","cleaned_patent_number":"8598119","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-28","publication_date":"2013-12-03","legal_status":"Granted"} US8598119B2 03 Dec, 2013 Granted 28 Dec, 2029
{"application_id":"1842","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"a7f49907e6344ea0badd","publication_number":"USRE48839E1","cleaned_patent_number":"RE48839","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-19","publication_date":"2021-12-07","legal_status":"Patented case"} USRE48839E1 07 Dec, 2021 Patented case 19 Aug, 2033
{"application_id":"35992","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"47b951e86fcf4c1f98d7","publication_number":"US10960009B2","cleaned_patent_number":"10960009","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-03","publication_date":"2021-03-30","legal_status":"Granted"} US10960009B2 30 Mar, 2021 Granted 03 Dec, 2034
{"application_id":"35994","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"47b951e86fcf4c1f98d7","publication_number":"US11026951B2","cleaned_patent_number":"11026951","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-03","publication_date":"2021-06-08","legal_status":"Granted"} US11026951B2 08 Jun, 2021 Granted 03 Dec, 2034
{"application_id":"35990","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"47b951e86fcf4c1f98d7","publication_number":"US9956227B2","cleaned_patent_number":"9956227","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-03","publication_date":"2018-05-01","legal_status":"Granted"} US9956227B2 01 May, 2018 Granted 03 Dec, 2034
{"application_id":"121792","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US12070459B2","cleaned_patent_number":"12070459","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2024-08-27","legal_status":"Granted"} US12070459B2 Formulation 27 Aug, 2024 Granted 30 Aug, 2039
{"application_id":"121720","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US20240216368A1","cleaned_patent_number":"12128043","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2024-10-29","legal_status":"Pending"} US12128043B2 Formulation 29 Oct, 2024 Pending 30 Aug, 2039
{"application_id":"31356","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US11806348B2","cleaned_patent_number":"11806348","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2023-11-07","legal_status":"Granted"} US11806348B2 Formulation 07 Nov, 2023 Granted 30 Aug, 2039
{"application_id":"36665","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US11690842B2","cleaned_patent_number":"11690842","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2023-07-04","legal_status":"Patented case"} US11690842B2 Formulation 04 Jul, 2023 Patented case 30 Aug, 2039
{"application_id":"36663","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US11052084B2","cleaned_patent_number":"11052084","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2021-07-06","legal_status":"Granted"} US11052084B2 Formulation 06 Jul, 2021 Granted 30 Aug, 2039
{"application_id":"36664","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"913c887ca9454d79aa4f","publication_number":"US10695345B2","cleaned_patent_number":"10695345","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-08-30","publication_date":"2020-06-30","legal_status":"Granted"} US10695345B2 Formulation 30 Jun, 2020 Granted 30 Aug, 2039
{"application_id":"34877","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"3320ef9f6abb4169ad0a","publication_number":"US11980617B2","cleaned_patent_number":"11980617","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-10-27","publication_date":"2024-05-14","legal_status":"Granted"} US11980617B2 14 May, 2024 Granted 27 Oct, 2039
{"application_id":"114780","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"97d2b146a8c6464c9312","publication_number":"US20240066030A1","cleaned_patent_number":"12090155","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-07-07","publication_date":"2024-02-29","legal_status":"Granted"} US12090155B2 Formulation 29 Feb, 2024 Granted 07 Jul, 2040
{"application_id":"119134","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"d6072994967c4350a6fe","publication_number":"US11753419B2","cleaned_patent_number":"11753419","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-10","publication_date":"2023-09-12","legal_status":"Granted"} US11753419B2 Formulation 12 Sep, 2023 Granted 10 Dec, 2040
{"application_id":"119703","ingredient":"LUMATEPERONE TOSYLATE","trade_name":"CAPLYTA","family_id":"d6072994967c4350a6fe","publication_number":"US20240002403A1","cleaned_patent_number":"12122792","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-12-10","publication_date":"2024-01-04","legal_status":"Granted"} US12122792B2 Formulation 04 Jan, 2024 Granted 10 Dec, 2040

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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