Pioglitazone Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 15 pharmaceutical companies such as NORVIUM BIOSCIENCE, CHARTWELL RX, TAKEDA PHARMS USA and others. It is marketed under 4 brand names, including PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE and others. Available in 13 different strengths, such as 850MG;EQ 15MG BASE, 500MG;EQ 15MG BASE, EQ 30MG BASE and others, and administered through 1 route including 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":"95150","ingredient":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"OSENI","family_id":"a68761525bab406db4fc","publication_number":"US8173663B2","cleaned_patent_number":"8173663","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-15","publication_date":"2012-05-08","legal_status":"Granted"} US8173663B2 08 May, 2012 Granted 15 Mar, 2025
{"application_id":"95152","ingredient":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"OSENI","family_id":"a68761525bab406db4fc","publication_number":"US8288539B2","cleaned_patent_number":"8288539","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-15","publication_date":"2012-10-16","legal_status":"Patented case"} US8288539B2 Molecular 16 Oct, 2012 Patented case 15 Mar, 2025
{"application_id":"84484","ingredient":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"ACTOPLUS MET XR","family_id":"7ced6bfba3614dfcba12","publication_number":"US7785627B2","cleaned_patent_number":"7785627","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-31","publication_date":"2010-08-31","legal_status":"Granted"} US7785627B2 Formulation 31 Aug, 2010 Granted 31 Jul, 2026
{"application_id":"84539","ingredient":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"ACTOPLUS MET XR","family_id":"7ced6bfba3614dfcba12","publication_number":"US7959946B2","cleaned_patent_number":"7959946","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-31","publication_date":"2011-06-14","legal_status":"Granted"} US7959946B2 Formulation 14 Jun, 2011 Granted 31 Jul, 2026
{"application_id":"89576","ingredient":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"ACTOPLUS MET","family_id":"1953db80db614db696b9","publication_number":"US9101660B2","cleaned_patent_number":"9101660","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-22","publication_date":"2015-08-11","legal_status":"Granted"} US9101660B2 Formulation 11 Aug, 2015 Granted 22 Jan, 2027
{"application_id":"92482","ingredient":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"DUETACT","family_id":"35f1b7819a6448aebf6c","publication_number":"US7700128B2","cleaned_patent_number":"7700128","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-30","publication_date":"2010-04-20","legal_status":"Granted"} US7700128B2 Formulation 20 Apr, 2010 Granted 30 Jan, 2027
{"application_id":"92457","ingredient":"GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"DUETACT","family_id":"0bf4cbe8c6554caea3ca","publication_number":"US8071130B2","cleaned_patent_number":"8071130","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-08","publication_date":"2011-12-06","legal_status":"Granted"} US8071130B2 Formulation 06 Dec, 2011 Granted 08 Jun, 2028
{"application_id":"95099","ingredient":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"OSENI","family_id":"a68761525bab406db4fc","publication_number":"US7807689B2","cleaned_patent_number":"7807689","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-27","publication_date":"2010-10-05","legal_status":"Patented case"} US7807689B2 Molecular Formulation 05 Oct, 2010 Patented case 27 Jun, 2028
{"application_id":"89606","ingredient":"METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"ACTOPLUS MET","family_id":"14c9530dc238481c900d","publication_number":"US9320714B2","cleaned_patent_number":"9320714","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-03","publication_date":"2016-04-26","legal_status":"Granted"} US9320714B2 Formulation 26 Apr, 2016 Granted 03 Feb, 2029
{"application_id":"97536","ingredient":"ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE","trade_name":"OSENI","family_id":"63d267c4bd1c4fe7b09f","publication_number":"US8637079B2","cleaned_patent_number":"8637079","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-04","publication_date":"2014-01-28","legal_status":"Granted"} US8637079B2 Formulation 28 Jan, 2014 Granted 04 Jun, 2029

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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