Saxagliptin Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 7 pharmaceutical companies such as ASTRAZENECA AB, SUN PHARM, MYLAN and others. It is marketed under 5 brand names, including KOMBIGLYZE XR, QTERN, QTERNMET XR and others. Available in 11 different strengths, such as 1GM;EQ 5MG BASE, 500MG;EQ 5MG BASE, 1GM;EQ 2.5MG BASE and others, and administered through 2 routes including TABLET, EXTENDED RELEASE;ORAL, TABLET;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":"129389","ingredient":"METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"KOMBIGLYZE XR","family_id":"93bf360deec84f4fbecc","publication_number":"US9339472B2","cleaned_patent_number":"9339472","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-13","publication_date":"2016-05-17","legal_status":"Patented case"} US9339472B2 Formulation 17 May, 2016 Patented case 13 Jul, 2025
{"application_id":"41918","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"KOMBIGLYZE XR","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":"1315","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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":"1322","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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":"129370","ingredient":"DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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":"1320","ingredient":"DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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":"41969","ingredient":"SAXAGLIPTIN HYDROCHLORIDE","trade_name":"ONGLYZA","family_id":"96987a76e85c48eeb0ee","publication_number":"US7951400B2","cleaned_patent_number":"7951400","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-30","publication_date":"2011-05-31","legal_status":"Patented case"} US7951400B2 Formulation 31 May, 2011 Patented case 30 Nov, 2028
{"application_id":"1318","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE","trade_name":"QTERN","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":"129386","ingredient":"DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE; SAXAGLIPTIN 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

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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API Suppliers/Manufacturer (Branded/Generic companies)

Manufacturing Locations

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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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