Dapagliflozin Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as ASTRAZENECA AB. It is marketed under 4 brand names, including FARXIGA, XIGDUO XR, QTERN and others. Available in 13 different strengths, such as 10MG, 5MG, 5MG;500MG and others, and administered through 2 routes including TABLET;ORAL, TABLET, EXTENDED RELEASE;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":"41918","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","family_id":"2c2dc51a052641d0a70a","publication_number":"US8628799B2","cleaned_patent_number":"8628799","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-13","publication_date":"2014-01-14","legal_status":"Patented case"} US8628799B2 Formulation 14 Jan, 2014 Patented case 13 Jul, 2025
{"application_id":"39969","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"914c5084e73143e7a5df","publication_number":"US8461105B2","cleaned_patent_number":"8461105","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-13","publication_date":"2013-06-11","legal_status":"Granted"} US8461105B2 11 Jun, 2013 Granted 13 Oct, 2025
{"application_id":"39968","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"914c5084e73143e7a5df","publication_number":"US8431685B2","cleaned_patent_number":"8431685","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-13","publication_date":"2013-04-30","legal_status":"Granted"} US8431685B2 30 Apr, 2013 Granted 13 Oct, 2025
{"application_id":"39931","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"914c5084e73143e7a5df","publication_number":"US7456254B2","cleaned_patent_number":"7456254","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-30","publication_date":"2008-11-25","legal_status":"Patented case"} US7456254B2 25 Nov, 2008 Patented case 30 Dec, 2025
{"application_id":"1315","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"16d27eafce1142e3979e","publication_number":"US6515117B2","cleaned_patent_number":"6515117","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-04","publication_date":"2003-02-04","legal_status":"Patented case"} US6515117B2 04 Feb, 2003 Patented case 04 Apr, 2026
{"application_id":"129376","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"658139e8eacc45fc8056","publication_number":"US8329648B2","cleaned_patent_number":"8329648","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-18","publication_date":"2012-12-11","legal_status":"Patented case"} US8329648B2 11 Dec, 2012 Patented case 18 Feb, 2027
{"application_id":"129378","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"658139e8eacc45fc8056","publication_number":"US8906851B2","cleaned_patent_number":"8906851","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-02-18","publication_date":"2014-12-09","legal_status":"Patented case"} US8906851B2 09 Dec, 2014 Patented case 18 Feb, 2027
{"application_id":"1322","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"4b7ba1cd2cc042648767","publication_number":"US8501698B2","cleaned_patent_number":"8501698","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-20","publication_date":"2013-08-06","legal_status":"Patented case"} US8501698B2 06 Aug, 2013 Patented case 20 Dec, 2027
{"application_id":"1320","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0844ff11d6e64e509841","publication_number":"US8221786B2","cleaned_patent_number":"8221786","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2012-07-17","legal_status":"Patented case"} US8221786B2 17 Jul, 2012 Patented case 21 Sep, 2028
{"application_id":"34219","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0844ff11d6e64e509841","publication_number":"US8716251B2","cleaned_patent_number":"8716251","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2014-05-06","legal_status":"Granted"} US8716251B2 06 May, 2014 Granted 21 Sep, 2028
{"application_id":"129370","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0844ff11d6e64e509841","publication_number":"US8361972B2","cleaned_patent_number":"8361972","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-09-21","publication_date":"2013-01-29","legal_status":"Granted"} US8361972B2 29 Jan, 2013 Granted 21 Sep, 2028
{"application_id":"1317","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0844ff11d6e64e509841","publication_number":"US7851502B2","cleaned_patent_number":"7851502","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-19","publication_date":"2010-12-14","legal_status":"Patented case"} US7851502B2 14 Dec, 2010 Patented case 19 Feb, 2029
{"application_id":"1318","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"4b7ba1cd2cc042648767","publication_number":"US7919598B2","cleaned_patent_number":"7919598","drug_product_flag":"-","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-16","publication_date":"2011-04-05","legal_status":"Patented case"} US7919598B2 05 Apr, 2011 Patented case 16 Jun, 2030
{"application_id":"40023","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"4732dfcaf9c34a599415","publication_number":"US8721615B2","cleaned_patent_number":"8721615","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-18","publication_date":"2014-05-13","legal_status":"Patented case"} US8721615B2 13 May, 2014 Patented case 18 Jul, 2030
{"application_id":"129358","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"9bbe193f427f4d7a8078","publication_number":"US8685934B2","cleaned_patent_number":"8685934","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-11-26","publication_date":"2014-04-01","legal_status":"Granted"} US8685934B2 01 Apr, 2014 Granted 26 Nov, 2030
{"application_id":"129386","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE","trade_name":"QTERNMET XR","family_id":"60d8d0915b8046e5bff1","publication_number":"US9616028B2","cleaned_patent_number":"9616028","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-05-12","publication_date":"2017-04-11","legal_status":"Patented case"} US9616028B2 11 Apr, 2017 Patented case 12 May, 2031
{"application_id":"118842","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"374c8501a10c496fb1dd","publication_number":"US11826376B2","cleaned_patent_number":"11826376","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-01-18","publication_date":"2023-11-28","legal_status":"Granted"} US11826376B2 28 Nov, 2023 Granted 18 Jan, 2040
{"application_id":"107446","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0f171d1bb2ee460aa50f","publication_number":"US11903955B2","cleaned_patent_number":"11903955","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-09","publication_date":"2024-02-20","legal_status":"Granted"} US11903955B2 20 Feb, 2024 Granted 09 Sep, 2040
{"application_id":"118843","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"0f171d1bb2ee460aa50f","publication_number":"US10973836B2","cleaned_patent_number":"10973836","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-09-09","publication_date":"2021-04-13","legal_status":"Granted"} US10973836B2 13 Apr, 2021 Granted 09 Sep, 2040
{"application_id":"2122","ingredient":"DAPAGLIFLOZIN","trade_name":"FARXIGA","family_id":"d0e3fe67090c494880fb","publication_number":"US20220023321A1","cleaned_patent_number":"12213988","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-04-01","publication_date":"2022-01-27","legal_status":"Pending"} US12213988B2 27 Jan, 2022 Pending 01 Apr, 2041

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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