Empagliflozin; Linagliptin; Metformin Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as BOEHRINGER INGELHEIM. It is marketed under 1 brand name, including TRIJARDY XR. Available in 4 different strengths, such as 5MG;2.5MG;1GM, 10MG;5MG;1GM, 12.5MG;2.5MG;1GM and others, and administered through 1 route including 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; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"87342","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"87266","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"TRIJARDY XR","family_id":"c57d5710bbb34b4bbd01","publication_number":"US10022379B2","cleaned_patent_number":"10022379","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-02","publication_date":"2018-07-17","legal_status":"Patented case"} US10022379B2 Formulation 17 Jul, 2018 Patented case 02 Apr, 2029
{"application_id":"128944","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","family_id":"c57d5710bbb34b4bbd01","publication_number":"US9415016B2","cleaned_patent_number":"9415016","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-02","publication_date":"2016-08-16","legal_status":"Patented case"} US9415016B2 Formulation 16 Aug, 2016 Patented case 02 Apr, 2029
{"application_id":"129630","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"2926","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"9248","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","family_id":"c57d5710bbb34b4bbd01","publication_number":"US9155705B2","cleaned_patent_number":"9155705","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-21","publication_date":"2015-10-13","legal_status":"Patented case"} US9155705B2 Formulation 13 Oct, 2015 Patented case 21 May, 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":"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":"Patented case"} US11564886B2 Formulation 31 Jan, 2023 Patented case 07 Mar, 2032
{"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":"27805","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"27803","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"27804","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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":"Patented case"} US11090323B2 17 Aug, 2021 Patented case 03 Oct, 2034
{"application_id":"27801","ingredient":"EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE","trade_name":"TRIJARDY XR","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

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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