Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 1 pharmaceutical company such as VERTEX PHARMS INC. It is marketed under 1 brand name, including TRIKAFTA (COPACKAGED). Available in 4 different strengths, such as 100MG,75MG,50MG; 150MG, 50MG,37.5MG,25MG; 75MG, 80MG, 60MG, 40MG;59.5MG and others, and administered through 2 routes including TABLET;ORAL, GRANULES;ORAL.

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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":"60038","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"e09c7c98df004651aacc","publication_number":"US8629162B2","cleaned_patent_number":"8629162","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-24","publication_date":"2014-01-14","legal_status":"Granted"} US8629162B2 14 Jan, 2014 Granted 24 Jun, 2025
{"application_id":"59926","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"e09c7c98df004651aacc","publication_number":"US8354427B2","cleaned_patent_number":"8354427","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-06","publication_date":"2013-01-15","legal_status":"Granted"} US8354427B2 15 Jan, 2013 Granted 06 Jul, 2026
{"application_id":"18759","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"f498ee3a318c48fe825d","publication_number":"US8410274B2","cleaned_patent_number":"8410274","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-28","publication_date":"2013-04-02","legal_status":"Granted"} US8410274B2 Formulation 02 Apr, 2013 Granted 28 Dec, 2026
{"application_id":"37396","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"f498ee3a318c48fe825d","publication_number":"US9931334B2","cleaned_patent_number":"9931334","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-28","publication_date":"2018-04-03","legal_status":"Granted"} US9931334B2 Formulation 03 Apr, 2018 Granted 28 Dec, 2026
{"application_id":"18783","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"f498ee3a318c48fe825d","publication_number":"US9670163B2","cleaned_patent_number":"9670163","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-28","publication_date":"2017-06-06","legal_status":"Granted"} US9670163B2 Formulation 06 Jun, 2017 Granted 28 Dec, 2026
{"application_id":"18770","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"f498ee3a318c48fe825d","publication_number":"US8754224B2","cleaned_patent_number":"8754224","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-12-28","publication_date":"2014-06-17","legal_status":"Granted"} US8754224B2 Molecular Formulation 17 Jun, 2014 Granted 28 Dec, 2026
{"application_id":"99901","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US10022352B2","cleaned_patent_number":"10022352","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-09","publication_date":"2018-07-17","legal_status":"Granted"} US10022352B2 Formulation 17 Jul, 2018 Granted 09 Apr, 2027
{"application_id":"99842","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US10239867B2","cleaned_patent_number":"10239867","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-09","publication_date":"2019-03-26","legal_status":"Patented case"} US10239867B2 Molecular Formulation 26 Mar, 2019 Patented case 09 Apr, 2027
{"application_id":"115159","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US11639347B2","cleaned_patent_number":"11639347","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-09","publication_date":"2023-05-02","legal_status":"Patented case"} US11639347B2 Molecular Formulation 02 May, 2023 Patented case 09 Apr, 2027
{"application_id":"99900","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US9974781B2","cleaned_patent_number":"9974781","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-04-09","publication_date":"2018-05-22","legal_status":"Granted"} US9974781B2 Formulation 22 May, 2018 Granted 09 Apr, 2027
{"application_id":"99894","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US8598181B2","cleaned_patent_number":"8598181","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-01","publication_date":"2013-12-03","legal_status":"Granted"} US8598181B2 03 Dec, 2013 Granted 01 May, 2027
{"application_id":"99890","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US7645789B2","cleaned_patent_number":"7645789","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-01","publication_date":"2010-01-12","legal_status":"Patented case"} US7645789B2 Molecular Formulation 12 Jan, 2010 Patented case 01 May, 2027
{"application_id":"99895","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US8623905B2","cleaned_patent_number":"8623905","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-01","publication_date":"2014-01-07","legal_status":"Granted"} US8623905B2 Molecular Formulation 07 Jan, 2014 Granted 01 May, 2027
{"application_id":"60034","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"e09c7c98df004651aacc","publication_number":"US7495103B2","cleaned_patent_number":"7495103","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-20","publication_date":"2009-02-24","legal_status":"Granted"} US7495103B2 Molecular Formulation 24 Feb, 2009 Granted 20 May, 2027
{"application_id":"99891","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US7776905B2","cleaned_patent_number":"7776905","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-03","publication_date":"2010-08-17","legal_status":"Granted"} US7776905B2 Molecular Formulation 17 Aug, 2010 Granted 03 Jun, 2027
{"application_id":"60036","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"e09c7c98df004651aacc","publication_number":"US8324242B2","cleaned_patent_number":"8324242","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-05","publication_date":"2012-12-04","legal_status":"Granted"} US8324242B2 04 Dec, 2012 Granted 05 Aug, 2027
{"application_id":"99892","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"887eedd2914f43d8abce","publication_number":"US8415387B2","cleaned_patent_number":"8415387","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-12","publication_date":"2013-04-09","legal_status":"Granted"} US8415387B2 09 Apr, 2013 Granted 12 Nov, 2027
{"application_id":"5128","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"eb52815d295f44058983","publication_number":"US10646481B2","cleaned_patent_number":"10646481","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-13","publication_date":"2020-05-12","legal_status":"Patented case"} US10646481B2 Formulation 12 May, 2020 Patented case 13 Aug, 2029
{"application_id":"35761","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"eb52815d295f44058983","publication_number":"US11564916B2","cleaned_patent_number":"11564916","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-13","publication_date":"2023-01-31","legal_status":"Patented case"} US11564916B2 31 Jan, 2023 Patented case 13 Aug, 2029
{"application_id":"35276","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"eda1a6912612404fab9d","publication_number":"US11578062B2","cleaned_patent_number":"11578062","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-25","publication_date":"2023-02-14","legal_status":"Granted"} US11578062B2 Formulation 14 Feb, 2023 Granted 25 Mar, 2031
{"application_id":"5904","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"eda1a6912612404fab9d","publication_number":"US10081621B2","cleaned_patent_number":"10081621","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-25","publication_date":"2018-09-25","legal_status":"Granted"} US10081621B2 Formulation 25 Sep, 2018 Granted 25 Mar, 2031
{"application_id":"6692","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"05abb66af4ef4f60b09c","publication_number":"US11147770B2","cleaned_patent_number":"11147770","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2021-10-19","legal_status":"Granted"} US11147770B2 Formulation 19 Oct, 2021 Granted 27 Feb, 2033
{"application_id":"38412","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"05abb66af4ef4f60b09c","publication_number":"US10272046B2","cleaned_patent_number":"10272046","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2019-04-30","legal_status":"Granted"} US10272046B2 Formulation 30 Apr, 2019 Granted 27 Feb, 2033
{"application_id":"42603","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"05abb66af4ef4f60b09c","publication_number":"US11752106B2","cleaned_patent_number":"11752106","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2023-09-12","legal_status":"Granted"} US11752106B2 Formulation 12 Sep, 2023 Granted 27 Feb, 2033
{"application_id":"164418","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"05abb66af4ef4f60b09c","publication_number":"US12214083B2","cleaned_patent_number":"12214083","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2025-02-04","legal_status":"Granted"} US12214083B2 Formulation 04 Feb, 2025 Granted 27 Feb, 2033
{"application_id":"6681","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"05abb66af4ef4f60b09c","publication_number":"US8883206B2","cleaned_patent_number":"8883206","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-27","publication_date":"2014-11-11","legal_status":"Granted"} US8883206B2 Formulation 11 Nov, 2014 Granted 27 Feb, 2033
{"application_id":"99968","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"08703da8642a47ad92a7","publication_number":"US9012496B2","cleaned_patent_number":"9012496","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-15","publication_date":"2015-04-21","legal_status":"Granted"} US9012496B2 21 Apr, 2015 Granted 15 Jul, 2033
{"application_id":"101380","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"f17e9f3269994bd79b55","publication_number":"US11426407B2","cleaned_patent_number":"11426407","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-06","publication_date":"2022-08-30","legal_status":"Granted"} US11426407B2 Molecular Formulation 30 Aug, 2022 Granted 06 Oct, 2035
{"application_id":"101340","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"9424a949be724b659394","publication_number":"US10758534B2","cleaned_patent_number":"10758534","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-10-06","publication_date":"2020-09-01","legal_status":"Granted"} US10758534B2 Molecular Formulation 01 Sep, 2020 Granted 06 Oct, 2035
{"application_id":"101400","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"c8a195c077574549a1b6","publication_number":"US10793547B2","cleaned_patent_number":"10793547","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-08","publication_date":"2020-10-06","legal_status":"Patented case"} US10793547B2 Molecular Formulation 06 Oct, 2020 Patented case 08 Dec, 2037
{"application_id":"109978","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"29ee9054d87d4b51b81b","publication_number":"US11517564B2","cleaned_patent_number":"11517564","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-08","publication_date":"2022-12-06","legal_status":"Granted"} US11517564B2 Formulation 06 Dec, 2022 Granted 08 Dec, 2037
{"application_id":"101385","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"4393955edeec4321be7f","publication_number":"US11179367B2","cleaned_patent_number":"11179367","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-08","publication_date":"2021-11-23","legal_status":"Granted"} US11179367B2 Formulation 23 Nov, 2021 Granted 08 Dec, 2037
{"application_id":"101435","ingredient":"ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR","trade_name":"TRIKAFTA (COPACKAGED)","family_id":"c8a195c077574549a1b6","publication_number":"US11453655B2","cleaned_patent_number":"11453655","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-12-08","publication_date":"2022-09-27","legal_status":"Granted"} US11453655B2 Molecular Formulation 27 Sep, 2022 Granted 08 Dec, 2037

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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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