Deutivacaftor; Tezacaftor; Vanzacaftor Calcium Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as VERTEX PHARMS INC. It is marketed under 1 brand name, including ALYFTREK. Available in 2 different strengths, such as 50MG;20MG;EQ 4MG BASE, 125MG;50MG;EQ 10MG BASE, and administered through 1 route including TABLET;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

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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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"18770","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"18759","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"18783","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"37396","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99842","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99901","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99900","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"115159","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"180493","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"887eedd2914f43d8abce","publication_number":"USRE50453E","cleaned_patent_number":"RE50453","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-01","publication_date":"2025-06-10","legal_status":"Patented case"} USRE50453E1 Molecular Formulation 10 Jun, 2025 Patented case 01 May, 2027
{"application_id":"99890","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99894","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99895","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"5904","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"35276","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"139416","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"65293c84b491425b9f21","publication_number":"US8865902B2","cleaned_patent_number":"8865902","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-17","publication_date":"2014-10-21","legal_status":"Granted"} US8865902B2 Molecular Formulation 21 Oct, 2014 Granted 17 May, 2032
{"application_id":"139414","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"65293c84b491425b9f21","publication_number":"US9512079B2","cleaned_patent_number":"9512079","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-17","publication_date":"2016-12-06","legal_status":"Granted"} US9512079B2 Molecular Formulation 06 Dec, 2016 Granted 17 May, 2032
{"application_id":"139417","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"65293c84b491425b9f21","publication_number":"US10047053B2","cleaned_patent_number":"10047053","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-17","publication_date":"2018-08-14","legal_status":"Granted"} US10047053B2 Molecular 14 Aug, 2018 Granted 17 May, 2032
{"application_id":"139413","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"65293c84b491425b9f21","publication_number":"US9181192B2","cleaned_patent_number":"9181192","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-17","publication_date":"2015-11-10","legal_status":"Patented case"} US9181192B2 Molecular Formulation 10 Nov, 2015 Patented case 17 May, 2032
{"application_id":"99960","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"08703da8642a47ad92a7","publication_number":"US10058546B2","cleaned_patent_number":"10058546","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-07-15","publication_date":"2018-08-28","legal_status":"Granted"} US10058546B2 28 Aug, 2018 Granted 15 Jul, 2033
{"application_id":"99968","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","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":"99955","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"d468db57ff40402fb3ad","publication_number":"US11951212B2","cleaned_patent_number":"11951212","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-14","publication_date":"2024-04-09","legal_status":"Granted"} US11951212B2 Formulation 09 Apr, 2024 Granted 14 Apr, 2035
{"application_id":"99910","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"d468db57ff40402fb3ad","publication_number":"US10206877B2","cleaned_patent_number":"10206877","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-14","publication_date":"2019-02-19","legal_status":"Granted"} US10206877B2 Formulation 19 Feb, 2019 Granted 14 Apr, 2035
{"application_id":"139415","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"","publication_number":"US11066417B2","cleaned_patent_number":"11066417","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-02-14","publication_date":"2021-07-20","legal_status":"Granted"} US11066417B2 Molecular Formulation 20 Jul, 2021 Granted 14 Feb, 2039
{"application_id":"139412","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"","publication_number":"US11866450B2","cleaned_patent_number":"11866450","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-02-14","publication_date":"2024-01-09","legal_status":"Patented Case"} US11866450B2 09 Jan, 2024 Patented Case 14 Feb, 2039
{"application_id":"139410","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"","publication_number":"US11873300B2","cleaned_patent_number":"11873300","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-13","publication_date":"2024-01-16","legal_status":"Granted"} US11873300B2 Molecular Formulation 16 Jan, 2024 Granted 13 Aug, 2040
{"application_id":"139411","ingredient":"DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM","trade_name":"ALYFTREK","family_id":"","publication_number":"US12186306B2","cleaned_patent_number":"12186306","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2043-01-10","publication_date":"2025-01-07","legal_status":"Granted"} US12186306B2 07 Jan, 2025 Granted 10 Jan, 2043

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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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