Acetaminophen Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 74 pharmaceutical companies such as MIKART, MALLINCKRODT HOSP, ENDO OPERATIONS and others. It is marketed under 22 brand names, including HYDROCODONE BITARTRATE AND ACETAMINOPHEN, OFIRMEV, BUTALBITAL AND ACETAMINOPHEN and others. Available in 38 different strengths, such as 300MG/15ML;10MG/15ML, 325MG;2.5MG, 650MG;5MG and others, and administered through 6 routes including SOLUTION;ORAL, TABLET;ORAL, SOLUTION;INTRAVENOUS and others.

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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":"112019","ingredient":"ACETAMINOPHEN; IBUPROFEN","trade_name":"COMBOGESIC","family_id":"6704e069f2d94a169e5b","publication_number":"US10532036B2","cleaned_patent_number":"10532036","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-09-22","publication_date":"2020-01-14","legal_status":"Granted"} US10532036B2 14 Jan, 2020 Granted 22 Sep, 2025
{"application_id":"88029","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"1a69898d0d7c4f29bc88","publication_number":"US7976870B2","cleaned_patent_number":"7976870","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-01","publication_date":"2011-07-12","legal_status":"Expired"} US7976870B2 12 Jul, 2011 Expired 01 Jun, 2027
{"application_id":"74108","ingredient":"ACETAMINOPHEN","trade_name":"OFIRMEV","family_id":"7aa4cb027c53414ca100","publication_number":"US10383834B2","cleaned_patent_number":"10383834","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-13","publication_date":"2019-08-20","legal_status":"Granted"} US10383834B2 20 Aug, 2019 Granted 13 Nov, 2028
{"application_id":"87989","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"51307b7e553747e3ab7f","publication_number":"US8668929B2","cleaned_patent_number":"8668929","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-11","publication_date":"2014-03-11","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8668929B2 11 Mar, 2014 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 11 Mar, 2029
{"application_id":"87999","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"51307b7e553747e3ab7f","publication_number":"US8394408B2","cleaned_patent_number":"8394408","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-11","publication_date":"2013-03-12","legal_status":"Expired"} US8394408B2 Formulation 12 Mar, 2013 Expired 11 Mar, 2029
{"application_id":"87997","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"51307b7e553747e3ab7f","publication_number":"US8372432B2","cleaned_patent_number":"8372432","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-03-11","publication_date":"2013-02-12","legal_status":"Expired"} US8372432B2 Formulation 12 Feb, 2013 Expired 11 Mar, 2029
{"application_id":"74113","ingredient":"ACETAMINOPHEN","trade_name":"OFIRMEV","family_id":"7aa4cb027c53414ca100","publication_number":"US9987238B2","cleaned_patent_number":"9987238","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-13","publication_date":"2018-06-05","legal_status":"Granted"} US9987238B2 05 Jun, 2018 Granted 13 May, 2029
{"application_id":"74112","ingredient":"ACETAMINOPHEN","trade_name":"OFIRMEV","family_id":"7aa4cb027c53414ca100","publication_number":"US9610265B2","cleaned_patent_number":"9610265","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-13","publication_date":"2017-04-04","legal_status":"Granted"} US9610265B2 04 Apr, 2017 Granted 13 May, 2029
{"application_id":"87998","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"51307b7e553747e3ab7f","publication_number":"US8377453B2","cleaned_patent_number":"8377453","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-19","publication_date":"2013-02-19","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8377453B2 Formulation 19 Feb, 2013 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 19 Nov, 2029
{"application_id":"72811","ingredient":"ACETAMINOPHEN","trade_name":"ACETAMINOPHEN","family_id":"f19029a7f80040e793da","publication_number":"US8741959B2","cleaned_patent_number":"8741959","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-19","publication_date":"2014-06-03","legal_status":"Granted"} US8741959B2 Formulation 03 Jun, 2014 Granted 19 Apr, 2030
{"application_id":"89928","ingredient":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","trade_name":"APADAZ","family_id":"25d3f6597529423890a6","publication_number":"US9549923B2","cleaned_patent_number":"9549923","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-01","publication_date":"2017-01-24","legal_status":"Granted"} US9549923B2 Molecular Formulation 24 Jan, 2017 Granted 01 Jul, 2030
{"application_id":"89926","ingredient":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","trade_name":"APADAZ","family_id":"25d3f6597529423890a6","publication_number":"US8828978B2","cleaned_patent_number":"8828978","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-01","publication_date":"2014-09-09","legal_status":"Granted"} US8828978B2 Formulation 09 Sep, 2014 Granted 01 Jul, 2030
{"application_id":"89898","ingredient":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","trade_name":"APADAZ","family_id":"25d3f6597529423890a6","publication_number":"US9132125B2","cleaned_patent_number":"9132125","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-01","publication_date":"2015-09-15","legal_status":"Patented case"} US9132125B2 Molecular Formulation 15 Sep, 2015 Patented case 01 Jul, 2030
{"application_id":"89924","ingredient":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","trade_name":"APADAZ","family_id":"25d3f6597529423890a6","publication_number":"US8748413B2","cleaned_patent_number":"8748413","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-07-01","publication_date":"2014-06-10","legal_status":"Granted"} US8748413B2 Molecular Formulation 10 Jun, 2014 Granted 01 Jul, 2030
{"application_id":"88041","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"f6bffbddccbf4bfab9a6","publication_number":"US8597681B2","cleaned_patent_number":"8597681","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-21","publication_date":"2013-12-03","legal_status":"Expired"} US8597681B2 Formulation 03 Dec, 2013 Expired 21 Dec, 2030
{"application_id":"88052","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"f6bffbddccbf4bfab9a6","publication_number":"US8980319B2","cleaned_patent_number":"8980319","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-21","publication_date":"2015-03-17","legal_status":"Expired"} US8980319B2 Formulation 17 Mar, 2015 Expired 21 Dec, 2030
{"application_id":"89923","ingredient":"ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE","trade_name":"APADAZ","family_id":"25d3f6597529423890a6","publication_number":"US8461137B2","cleaned_patent_number":"8461137","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-02-22","publication_date":"2013-06-11","legal_status":"Granted"} US8461137B2 Molecular Formulation 11 Jun, 2013 Granted 22 Feb, 2031
{"application_id":"117879","ingredient":"ACETAMINOPHEN; IBUPROFEN SODIUM","trade_name":"COMBOGESIC IV","family_id":"c40c1caa707f4b5e91fa","publication_number":"US11896567B2","cleaned_patent_number":"11896567","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-26","publication_date":"2024-02-13","legal_status":"Granted"} US11896567B2 13 Feb, 2024 Granted 26 Oct, 2031
{"application_id":"117847","ingredient":"ACETAMINOPHEN; IBUPROFEN SODIUM","trade_name":"COMBOGESIC IV","family_id":"c40c1caa707f4b5e91fa","publication_number":"US11446266B2","cleaned_patent_number":"11446266","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-26","publication_date":"2022-09-20","legal_status":"Granted"} US11446266B2 20 Sep, 2022 Granted 26 Oct, 2031
{"application_id":"74111","ingredient":"ACETAMINOPHEN","trade_name":"OFIRMEV","family_id":"7aa4cb027c53414ca100","publication_number":"US9399012B2","cleaned_patent_number":"9399012","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-11","publication_date":"2016-07-26","legal_status":"Granted"} US9399012B2 26 Jul, 2016 Granted 11 Mar, 2032
{"application_id":"88011","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"a65e2e5eb43642ba9e49","publication_number":"US8658631B1","cleaned_patent_number":"8658631","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-16","publication_date":"2014-02-25","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8658631B2 Formulation 25 Feb, 2014 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 16 May, 2032
{"application_id":"88017","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"a65e2e5eb43642ba9e49","publication_number":"US9468636B2","cleaned_patent_number":"9468636","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-16","publication_date":"2016-10-18","legal_status":"Expired"} US9468636B2 18 Oct, 2016 Expired 16 May, 2032
{"application_id":"88014","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"a65e2e5eb43642ba9e49","publication_number":"US8992975B2","cleaned_patent_number":"8992975","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-16","publication_date":"2015-03-31","legal_status":"Expired"} US8992975B2 Formulation 31 Mar, 2015 Expired 16 May, 2032
{"application_id":"88015","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"a65e2e5eb43642ba9e49","publication_number":"US9050335B1","cleaned_patent_number":"9050335","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-16","publication_date":"2015-06-09","legal_status":"Expired"} US9050335B2 Formulation 09 Jun, 2015 Expired 16 May, 2032
{"application_id":"88010","ingredient":"ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE","trade_name":"XARTEMIS XR","family_id":"a65e2e5eb43642ba9e49","publication_number":"US8741885B1","cleaned_patent_number":"8741885","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-16","publication_date":"2014-06-03","legal_status":"Expired"} US8741885B2 Formulation 03 Jun, 2014 Expired 16 May, 2032
{"application_id":"117912","ingredient":"ACETAMINOPHEN; IBUPROFEN SODIUM","trade_name":"COMBOGESIC IV","family_id":"51a839178a0b451ca292","publication_number":"US11389416B2","cleaned_patent_number":"11389416","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-07-17","publication_date":"2022-07-19","legal_status":"Granted"} US11389416B2 Formulation 19 Jul, 2022 Granted 17 Jul, 2035
{"application_id":"117913","ingredient":"ACETAMINOPHEN; IBUPROFEN SODIUM","trade_name":"COMBOGESIC IV","family_id":"51a839178a0b451ca292","publication_number":"US2023181502A1","cleaned_patent_number":"12083087","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-07-17","publication_date":"2023-06-15","legal_status":"Granted"} US12083087B2 15 Jun, 2023 Granted 17 Jul, 2035
{"application_id":"117883","ingredient":"ACETAMINOPHEN; IBUPROFEN SODIUM","trade_name":"COMBOGESIC IV","family_id":"51a839178a0b451ca292","publication_number":"US11213498B2","cleaned_patent_number":"11213498","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-01-14","publication_date":"2022-01-04","legal_status":"Granted"} US11213498B2 Formulation 04 Jan, 2022 Granted 14 Jan, 2036
{"application_id":"112066","ingredient":"ACETAMINOPHEN; IBUPROFEN","trade_name":"COMBOGESIC","family_id":"0d2edaaf419348bc900b","publication_number":"US11534407B2","cleaned_patent_number":"11534407","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-02-27","publication_date":"2022-12-27","legal_status":"Granted"} US11534407B2 Formulation 27 Dec, 2022 Granted 27 Feb, 2039
{"application_id":"112047","ingredient":"ACETAMINOPHEN; IBUPROFEN","trade_name":"COMBOGESIC","family_id":"0d2edaaf419348bc900b","publication_number":"US11197830B2","cleaned_patent_number":"11197830","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-02-27","publication_date":"2021-12-14","legal_status":"Granted"} US11197830B2 Formulation 14 Dec, 2021 Granted 27 Feb, 2039
{"application_id":"122916","ingredient":"ACETAMINOPHEN; IBUPROFEN","trade_name":"ADVIL DUAL ACTION WITH ACETAMINOPHEN","family_id":"","publication_number":"US11918693B2","cleaned_patent_number":"11918693","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2041-07-09","publication_date":"2024-03-05","legal_status":"Granted"} US11918693B2 Formulation 05 Mar, 2024 Granted 09 Jul, 2041

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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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