Linagliptin Global Patent Coverage & Expiry Overview

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It is formulated by 4 pharmaceutical companies such as BOEHRINGER INGELHEIM, SUNSHINE, ZYDUS PHARMS and others. It is marketed under 7 brand names, including TRADJENTA, JENTADUETO, GLYXAMBI and others. Available in 11 different strengths, such as 5MG, 2.5MG;850MG, 2.5MG;1GM and others, and administered through 2 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;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":"3674","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"d0f4545c1bbb47d3817d","publication_number":"US7407955B2","cleaned_patent_number":"7407955","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-11-02","publication_date":"2008-08-05","legal_status":"Patented case"} US7407955B2 05 Aug, 2008 Patented case 02 Nov, 2025
{"application_id":"128938","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"b005fd93319f450e8697","publication_number":"US8883805B2","cleaned_patent_number":"8883805","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-05-26","publication_date":"2014-11-11","legal_status":"Patented case"} US8883805B2 11 Nov, 2014 Patented case 26 May, 2026
{"application_id":"122576","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"91003f57f7284bc6a121","publication_number":"US12178819B2","cleaned_patent_number":"12178819","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-04","publication_date":"2024-12-31","legal_status":"Granted"} US12178819B2 Formulation 31 Dec, 2024 Granted 04 May, 2027
{"application_id":"87342","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"ffc4172272ab426986ef","publication_number":"US7713938B2","cleaned_patent_number":"7713938","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-10-15","publication_date":"2010-05-11","legal_status":"Patented case"} US7713938B2 11 May, 2010 Patented case 15 Oct, 2027
{"application_id":"4488","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"d085a2058e3c4372af39","publication_number":"US8673927B2","cleaned_patent_number":"8673927","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-04","publication_date":"2014-03-18","legal_status":"Patented case"} US8673927B2 18 Mar, 2014 Patented case 04 Nov, 2027
{"application_id":"128933","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"d085a2058e3c4372af39","publication_number":"US9173859B2","cleaned_patent_number":"9173859","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-04","publication_date":"2015-11-03","legal_status":"Patented case"} US9173859B2 03 Nov, 2015 Patented case 04 Nov, 2027
{"application_id":"94167","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"91003f57f7284bc6a121","publication_number":"US11033552B2","cleaned_patent_number":"11033552","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-04","publication_date":"2021-06-15","legal_status":"Granted"} US11033552B2 15 Jun, 2021 Granted 04 Nov, 2027
{"application_id":"87266","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"791f672105f54f7991fb","publication_number":"US7579449B2","cleaned_patent_number":"7579449","drug_product_flag":"-","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-01","publication_date":"2009-08-25","legal_status":"Court proceedings terminated"} US7579449B2 25 Aug, 2009 Court proceedings terminated 01 Feb, 2029
{"application_id":"128943","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"JENTADUETO","family_id":"c57d5710bbb34b4bbd01","publication_number":"US10022379B2","cleaned_patent_number":"10022379","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-02","publication_date":"2018-07-17","legal_status":"Patented case"} US10022379B2 17 Jul, 2018 Patented case 02 Oct, 2029
{"application_id":"9271","ingredient":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"JENTADUETO","family_id":"c57d5710bbb34b4bbd01","publication_number":"US10973827B2","cleaned_patent_number":"10973827","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-02","publication_date":"2021-04-13","legal_status":"Granted"} US10973827B2 13 Apr, 2021 Granted 02 Oct, 2029
{"application_id":"128944","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"JENTADUETO","family_id":"c57d5710bbb34b4bbd01","publication_number":"US9415016B2","cleaned_patent_number":"9415016","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-02","publication_date":"2016-08-16","legal_status":"Patented case"} US9415016B2 16 Aug, 2016 Patented case 02 Oct, 2029
{"application_id":"5086","ingredient":"LINAGLIPTIN","trade_name":"TRADJENTA","family_id":"edaa52a884594b88a7a5","publication_number":"US10034877B2","cleaned_patent_number":"10034877","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-05","publication_date":"2018-07-31","legal_status":"Patented case"} US10034877B2 31 Jul, 2018 Patented case 05 Feb, 2030
{"application_id":"129345","ingredient":"LINAGLIPTIN","trade_name":"TRADJENTA","family_id":"edaa52a884594b88a7a5","publication_number":"US9486526B2","cleaned_patent_number":"9486526","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-05","publication_date":"2016-11-08","legal_status":"Granted"} US9486526B2 08 Nov, 2016 Granted 05 Feb, 2030
{"application_id":"129630","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"a8cfb2e0910e427380e7","publication_number":"US12115179B2","cleaned_patent_number":"12115179","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-11","publication_date":"2024-10-15","legal_status":"Patented case"} US12115179B2 15 Oct, 2024 Patented case 11 Feb, 2030
{"application_id":"129347","ingredient":"LINAGLIPTIN","trade_name":"JENTADUETO","family_id":"c0d9634ba3f048cfbe74","publication_number":"US11911388B2","cleaned_patent_number":"11911388","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-10","publication_date":"2024-02-27","legal_status":"Patented case"} US11911388B2 27 Feb, 2024 Patented case 10 Apr, 2030
{"application_id":"2926","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"9b474d4dce3f44d08a3b","publication_number":"US8551957B2","cleaned_patent_number":"8551957","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-14","publication_date":"2013-10-08","legal_status":"Patented case"} US8551957B2 08 Oct, 2013 Patented case 14 Apr, 2030
{"application_id":"128946","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","family_id":"a8cfb2e0910e427380e7","publication_number":"US10406172B2","cleaned_patent_number":"10406172","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-15","publication_date":"2019-09-10","legal_status":"Patented case"} US10406172B2 Formulation 10 Sep, 2019 Patented case 15 Jun, 2030
{"application_id":"9248","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"JENTADUETO","family_id":"c57d5710bbb34b4bbd01","publication_number":"US9155705B2","cleaned_patent_number":"9155705","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-21","publication_date":"2015-10-13","legal_status":"Granted"} US9155705B2 13 Oct, 2015 Granted 21 Nov, 2030
{"application_id":"94995","ingredient":"LINAGLIPTIN","trade_name":"JENTADUETO","family_id":"8c31d33095a84bf78392","publication_number":"US8846695B2","cleaned_patent_number":"8846695","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-04","publication_date":"2014-09-30","legal_status":"Expired"} US8846695B2 30 Sep, 2014 Expired 04 Dec, 2030
{"application_id":"129344","ingredient":"LINAGLIPTIN","trade_name":"TRADJENTA","family_id":"edaa52a884594b88a7a5","publication_number":"US8853156B2","cleaned_patent_number":"8853156","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-05","publication_date":"2014-10-07","legal_status":"Patented case"} US8853156B2 07 Oct, 2014 Patented case 05 Sep, 2031
{"application_id":"87243","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","family_id":"3172922541784e29b519","publication_number":"US10596120B2","cleaned_patent_number":"10596120","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-07","publication_date":"2020-03-24","legal_status":"Patented case"} US10596120B2 Formulation 24 Mar, 2020 Patented case 07 Mar, 2032
{"application_id":"87261","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","family_id":"3172922541784e29b519","publication_number":"US11564886B2","cleaned_patent_number":"11564886","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-07","publication_date":"2023-01-31","legal_status":"Granted"} US11564886B2 Formulation 31 Jan, 2023 Granted 07 Mar, 2032
{"application_id":"86175","ingredient":"LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"JENTADUETO XR","family_id":"0a3c5d67d5ba489a965b","publication_number":"US9555001B2","cleaned_patent_number":"9555001","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-09-06","publication_date":"2017-01-31","legal_status":"Patented case"} US9555001B2 31 Jan, 2017 Patented case 06 Sep, 2033
{"application_id":"27805","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"71430f9a55cb497db184","publication_number":"US11833166B2","cleaned_patent_number":"11833166","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-04-03","publication_date":"2023-12-05","legal_status":"Patented case"} US11833166B2 05 Dec, 2023 Patented case 03 Apr, 2034
{"application_id":"27804","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"71430f9a55cb497db184","publication_number":"US11090323B2","cleaned_patent_number":"11090323","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-03","publication_date":"2021-08-17","legal_status":"Granted"} US11090323B2 17 Aug, 2021 Granted 03 Oct, 2034
{"application_id":"27803","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"71430f9a55cb497db184","publication_number":"US10258637B2","cleaned_patent_number":"10258637","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-10-03","publication_date":"2019-04-16","legal_status":"Patented case"} US10258637B2 16 Apr, 2019 Patented case 03 Oct, 2034
{"application_id":"27801","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN","trade_name":"GLYXAMBI","family_id":"71430f9a55cb497db184","publication_number":"US9949998B2","cleaned_patent_number":"9949998","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-12-11","publication_date":"2018-04-24","legal_status":"Patented case"} US9949998B2 24 Apr, 2018 Patented case 11 Dec, 2034

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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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