Ivacaftor; Lumacaftor 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 ORKAMBI. Available in 5 different strengths, such as 125MG;200MG, 125MG;100MG, 125MG/PACKET;100MG/PACKET and others, and administered through 2 routes including TABLET;ORAL, GRANULE;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":"60146","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"31f50dd378bc47e7ae5c","publication_number":"US8741933B2","cleaned_patent_number":"8741933","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-08","publication_date":"2014-06-03","legal_status":"Patented case"} US8741933B2 03 Jun, 2014 Patented case 08 May, 2027
{"application_id":"60149","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"31f50dd378bc47e7ae5c","publication_number":"US9216969B2","cleaned_patent_number":"9216969","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-08","publication_date":"2015-12-22","legal_status":"Granted"} US9216969B2 22 Dec, 2015 Granted 08 May, 2027
{"application_id":"60060","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"31f50dd378bc47e7ae5c","publication_number":"US7973038B2","cleaned_patent_number":"7973038","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-08","publication_date":"2011-07-05","legal_status":"Granted"} US7973038B2 05 Jul, 2011 Granted 08 May, 2027
{"application_id":"37396","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"f498ee3a318c48fe825d","publication_number":"US9931334B2","cleaned_patent_number":"9931334","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-28","publication_date":"2018-04-03","legal_status":"Granted"} US9931334B2 03 Apr, 2018 Granted 28 Jun, 2027
{"application_id":"18759","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"f498ee3a318c48fe825d","publication_number":"US8410274B2","cleaned_patent_number":"8410274","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-28","publication_date":"2013-04-02","legal_status":"Granted"} US8410274B2 02 Apr, 2013 Granted 28 Jun, 2027
{"application_id":"18783","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"f498ee3a318c48fe825d","publication_number":"US9670163B2","cleaned_patent_number":"9670163","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-28","publication_date":"2017-06-06","legal_status":"Granted"} US9670163B2 06 Jun, 2017 Granted 28 Jun, 2027
{"application_id":"18770","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","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":"2027-06-28","publication_date":"2014-06-17","legal_status":"Granted"} US8754224B2 17 Jun, 2014 Granted 28 Jun, 2027
{"application_id":"60034","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","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":"2027-11-20","publication_date":"2009-02-24","legal_status":"Granted"} US7495103B2 24 Feb, 2009 Granted 20 Nov, 2027
{"application_id":"60036","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"e09c7c98df004651aacc","publication_number":"US8324242B2","cleaned_patent_number":"8324242","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-02-05","publication_date":"2012-12-04","legal_status":"Granted"} US8324242B2 04 Dec, 2012 Granted 05 Feb, 2028
{"application_id":"37496","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US8653103B2","cleaned_patent_number":"8653103","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2014-02-18","legal_status":"Granted"} US8653103B2 18 Feb, 2014 Granted 04 Jun, 2029
{"application_id":"37501","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US10597384B2","cleaned_patent_number":"10597384","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2020-03-24","legal_status":"Granted"} US10597384B2 24 Mar, 2020 Granted 04 Jun, 2029
{"application_id":"97523","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"d70394355c644077b260","publication_number":"US11052075B2","cleaned_patent_number":"11052075","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2021-07-06","legal_status":"Granted"} US11052075B2 06 Jul, 2021 Granted 04 Jun, 2029
{"application_id":"37502","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US12065432B2","cleaned_patent_number":"12065432","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2024-08-20","legal_status":"Granted"} US12065432B2 20 Aug, 2024 Granted 04 Jun, 2029
{"application_id":"97462","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"d70394355c644077b260","publication_number":"US10076513B2","cleaned_patent_number":"10076513","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2018-09-18","legal_status":"Granted"} US10076513B2 18 Sep, 2018 Granted 04 Jun, 2029
{"application_id":"4958","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US9150552B2","cleaned_patent_number":"9150552","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2015-10-06","legal_status":"Granted"} US9150552B2 06 Oct, 2015 Granted 04 Jun, 2029
{"application_id":"37497","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US8846718B2","cleaned_patent_number":"8846718","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-01-02","publication_date":"2014-09-30","legal_status":"Granted"} US8846718B2 30 Sep, 2014 Granted 02 Jan, 2030
{"application_id":"35761","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"eb52815d295f44058983","publication_number":"US11564916B2","cleaned_patent_number":"11564916","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-13","publication_date":"2023-01-31","legal_status":"Patented case"} US11564916B2 31 Jan, 2023 Patented case 13 Feb, 2030
{"application_id":"5128","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"eb52815d295f44058983","publication_number":"US10646481B2","cleaned_patent_number":"10646481","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-13","publication_date":"2020-05-12","legal_status":"Patented case"} US10646481B2 12 May, 2020 Patented case 13 Feb, 2030
{"application_id":"60189","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"1b7bcf1f10dc46a0b0c4","publication_number":"US9192606B2","cleaned_patent_number":"9192606","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-29","publication_date":"2015-11-24","legal_status":"Granted"} US9192606B2 24 Nov, 2015 Granted 29 Mar, 2030
{"application_id":"4930","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"52e59fc4c53e479c8369","publication_number":"US8507534B2","cleaned_patent_number":"8507534","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-20","publication_date":"2013-08-13","legal_status":"Granted"} US8507534B2 13 Aug, 2013 Granted 20 Mar, 2031
{"application_id":"60175","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"1b7bcf1f10dc46a0b0c4","publication_number":"US8716338B2","cleaned_patent_number":"8716338","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-20","publication_date":"2014-05-06","legal_status":"Granted"} US8716338B2 06 May, 2014 Granted 20 Mar, 2031
{"application_id":"60148","ingredient":"IVACAFTOR; LUMACAFTOR","trade_name":"ORKAMBI","family_id":"31f50dd378bc47e7ae5c","publication_number":"US8993600B2","cleaned_patent_number":"8993600","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-11","publication_date":"2015-03-31","legal_status":"Granted"} US8993600B2 31 Mar, 2015 Granted 11 Jun, 2031

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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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