Naltrexone Global Patent Coverage & Expiry Overview

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It is formulated by 10 pharmaceutical companies such as SALIX PHARMS, ACCORD HLTHCARE, SUN PHARM and others. It is marketed under 6 brand names, including RELISTOR, NALTREXONE HYDROCHLORIDE, CONTRAVE and others. Available in 12 different strengths, such as 8MG/0.4ML (8MG/0.4ML), 12MG/0.6ML (12MG/0.6ML), 50MG and others, and administered through 5 routes including SOLUTION;SUBCUTANEOUS, TABLET;ORAL, TABLET, EXTENDED RELEASE;ORAL 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

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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":"84788","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"78bfd13ae7384cd2a3fe","publication_number":"US7375111B2","cleaned_patent_number":"7375111","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-03-26","publication_date":"2008-05-20","legal_status":"Granted"} US7375111B2 Formulation 20 May, 2008 Granted 26 Mar, 2025
{"application_id":"44215","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US8685443B2","cleaned_patent_number":"8685443","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-03","publication_date":"2014-04-01","legal_status":"Expired"} US8685443B2 01 Apr, 2014 Expired 03 Jul, 2025
{"application_id":"44232","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US8685444B2","cleaned_patent_number":"8685444","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-03","publication_date":"2014-04-01","legal_status":"Expired"} US8685444B2 Formulation 01 Apr, 2014 Expired 03 Jul, 2025
{"application_id":"84855","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"f4ab2e8a55494ba288db","publication_number":"US9107837B2","cleaned_patent_number":"9107837","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-04","publication_date":"2015-08-18","legal_status":"Granted"} US9107837B2 18 Aug, 2015 Granted 04 Jun, 2027
{"application_id":"44286","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US7682634B2","cleaned_patent_number":"7682634","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2010-03-23","legal_status":"Expired"} US7682634B2 Formulation 23 Mar, 2010 Expired 19 Jun, 2027
{"application_id":"44289","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8877247B2","cleaned_patent_number":"8877247","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2014-11-04","legal_status":"Expired"} US8877247B2 Formulation 04 Nov, 2014 Expired 19 Jun, 2027
{"application_id":"44288","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8846104B2","cleaned_patent_number":"8846104","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2014-09-30","legal_status":"Expired"} US8846104B2 Formulation 30 Sep, 2014 Expired 19 Jun, 2027
{"application_id":"44287","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US8158156B2","cleaned_patent_number":"8158156","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2012-04-17","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8158156B2 17 Apr, 2012 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 19 Jun, 2027
{"application_id":"44236","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"716d8999e0e74342b162","publication_number":"US7682633B2","cleaned_patent_number":"7682633","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-19","publication_date":"2010-03-23","legal_status":"Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362"} US7682633B2 23 Mar, 2010 Patent Expired Due to NonPayment of Maintenance Fees Under 37 CFR 1.362 19 Jun, 2027
{"application_id":"242139","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"","publication_number":"US12303592B2","cleaned_patent_number":"12303592","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-03","publication_date":"2025-05-20","legal_status":"Granted"} US12303592B2 Formulation 20 May, 2025 Granted 03 Aug, 2027
{"application_id":"84995","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"47cd997faa684290a198","publication_number":"US8318788B2","cleaned_patent_number":"8318788","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2012-11-27","legal_status":"Patented case"} US8318788B2 27 Nov, 2012 Patented case 08 Nov, 2027
{"application_id":"84823","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"c1bb9e6e538e43f387d8","publication_number":"US20200352863A1","cleaned_patent_number":"12048769","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2020-11-12","legal_status":"Abandoned"} US12048769B2 12 Nov, 2020 Abandoned 08 Nov, 2027
{"application_id":"84819","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"c1bb9e6e538e43f387d8","publication_number":"US10307376B2","cleaned_patent_number":"10307376","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2019-06-04","legal_status":"Granted"} US10307376B2 04 Jun, 2019 Granted 08 Nov, 2027
{"application_id":"84799","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"c1bb9e6e538e43f387d8","publication_number":"US8722085B2","cleaned_patent_number":"8722085","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2014-05-13","legal_status":"Granted"} US8722085B2 13 May, 2014 Granted 08 Nov, 2027
{"application_id":"84818","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"c1bb9e6e538e43f387d8","publication_number":"US9125868B2","cleaned_patent_number":"9125868","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-08","publication_date":"2015-09-08","legal_status":"Granted"} US9125868B2 08 Sep, 2015 Granted 08 Nov, 2027
{"application_id":"44231","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"554e0edd0efb43dbbc25","publication_number":"US7815934B2","cleaned_patent_number":"7815934","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-12","publication_date":"2010-10-19","legal_status":"Expired"} US7815934B2 Formulation 19 Oct, 2010 Expired 12 Dec, 2027
{"application_id":"85024","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"47cd997faa684290a198","publication_number":"US8088786B2","cleaned_patent_number":"8088786","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-02-03","publication_date":"2012-01-03","legal_status":"Granted"} US8088786B2 Formulation 03 Jan, 2012 Granted 03 Feb, 2029
{"application_id":"85030","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"2698804f96da4bd2a03f","publication_number":"US11324741B2","cleaned_patent_number":"11324741","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-05-29","publication_date":"2022-05-10","legal_status":"Granted"} US11324741B2 10 May, 2022 Granted 29 May, 2029
{"application_id":"79851","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US9724343B2","cleaned_patent_number":"9724343","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-30","publication_date":"2017-08-08","legal_status":"Granted"} US9724343B2 Formulation 08 Aug, 2017 Granted 30 Sep, 2029
{"application_id":"79814","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US8420663B2","cleaned_patent_number":"8420663","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-30","publication_date":"2013-04-16","legal_status":"Granted"} US8420663B2 16 Apr, 2013 Granted 30 Sep, 2029
{"application_id":"79848","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US8822490B2","cleaned_patent_number":"8822490","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-30","publication_date":"2014-09-02","legal_status":"Granted"} US8822490B2 Formulation 02 Sep, 2014 Granted 30 Sep, 2029
{"application_id":"79849","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US9180125B2","cleaned_patent_number":"9180125","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-30","publication_date":"2015-11-10","legal_status":"Granted"} US9180125B2 Formulation 10 Nov, 2015 Granted 30 Sep, 2029
{"application_id":"79850","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US9492445B2","cleaned_patent_number":"9492445","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-30","publication_date":"2016-11-15","legal_status":"Granted"} US9492445B2 Formulation 15 Nov, 2016 Granted 30 Sep, 2029
{"application_id":"57843","ingredient":"NALTREXONE","trade_name":"VIVITROL","family_id":"36062ea5548b47739534","publication_number":"US7919499B2","cleaned_patent_number":"7919499","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-10-15","publication_date":"2011-04-05","legal_status":"Granted"} US7919499B2 05 Apr, 2011 Granted 15 Oct, 2029
{"application_id":"44297","ingredient":"MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE","trade_name":"EMBEDA","family_id":"bfa31f6ebb63470f9660","publication_number":"US8623418B2","cleaned_patent_number":"8623418","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-11-07","publication_date":"2014-01-07","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8623418B2 07 Jan, 2014 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 07 Nov, 2029
{"application_id":"84864","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"f4ab2e8a55494ba288db","publication_number":"US8916195B2","cleaned_patent_number":"8916195","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-02-02","publication_date":"2014-12-23","legal_status":"Granted"} US8916195B2 23 Dec, 2014 Granted 02 Feb, 2030
{"application_id":"79846","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"d8c7da3383e348c991a6","publication_number":"US8247425B2","cleaned_patent_number":"8247425","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-12-31","publication_date":"2012-08-21","legal_status":"Patented case"} US8247425B2 21 Aug, 2012 Patented case 31 Dec, 2030
{"application_id":"84972","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"a25d0f137f20461c9b7b","publication_number":"US11033543B2","cleaned_patent_number":"11033543","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-10","publication_date":"2021-06-15","legal_status":"Granted"} US11033543B2 15 Jun, 2021 Granted 10 Jan, 2031
{"application_id":"98496","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"840a25d1f0254699b8c5","publication_number":"US9314461B2","cleaned_patent_number":"9314461","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2016-04-19","legal_status":"Granted"} US9314461B2 Formulation 19 Apr, 2016 Granted 10 Mar, 2031
{"application_id":"98495","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"840a25d1f0254699b8c5","publication_number":"US8956651B2","cleaned_patent_number":"8956651","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2015-02-17","legal_status":"Granted"} US8956651B2 Formulation 17 Feb, 2015 Granted 10 Mar, 2031
{"application_id":"98497","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"840a25d1f0254699b8c5","publication_number":"US10376505B2","cleaned_patent_number":"10376505","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2019-08-13","legal_status":"Granted"} US10376505B2 Formulation 13 Aug, 2019 Granted 10 Mar, 2031
{"application_id":"98450","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"840a25d1f0254699b8c5","publication_number":"US10307417B2","cleaned_patent_number":"10307417","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2019-06-04","legal_status":"Granted"} US10307417B2 Formulation 04 Jun, 2019 Granted 10 Mar, 2031
{"application_id":"98494","ingredient":"METHYLNALTREXONE BROMIDE","trade_name":"RELISTOR","family_id":"840a25d1f0254699b8c5","publication_number":"US8524276B2","cleaned_patent_number":"8524276","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-03-10","publication_date":"2013-09-03","legal_status":"Granted"} US8524276B2 Formulation 03 Sep, 2013 Granted 10 Mar, 2031
{"application_id":"84990","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"a25d0f137f20461c9b7b","publication_number":"US9248123B2","cleaned_patent_number":"9248123","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-13","publication_date":"2016-02-02","legal_status":"Granted"} US9248123B2 02 Feb, 2016 Granted 13 Jan, 2032
{"application_id":"84967","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"36e599b828c34fd49bd8","publication_number":"US10403170B2","cleaned_patent_number":"10403170","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-05","publication_date":"2019-09-03","legal_status":"Granted"} US10403170B2 03 Sep, 2019 Granted 05 Jun, 2033
{"application_id":"84923","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"36e599b828c34fd49bd8","publication_number":"US11139056B2","cleaned_patent_number":"11139056","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-05","publication_date":"2021-10-05","legal_status":"Granted"} US11139056B2 05 Oct, 2021 Granted 05 Jun, 2033
{"application_id":"84966","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"36e599b828c34fd49bd8","publication_number":"US9633575B2","cleaned_patent_number":"9633575","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-06-25","publication_date":"2017-04-25","legal_status":"Granted"} US9633575B2 25 Apr, 2017 Granted 25 Jun, 2033
{"application_id":"84914","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"fedd7e26e7a3466ea267","publication_number":"US10835527B2","cleaned_patent_number":"10835527","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-02","publication_date":"2020-11-17","legal_status":"Expired"} US10835527B2 17 Nov, 2020 Expired 02 Jul, 2034
{"application_id":"84915","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"fedd7e26e7a3466ea267","publication_number":"US11998542B2","cleaned_patent_number":"11998542","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-02","publication_date":"2024-06-04","legal_status":"Granted"} US11998542B2 04 Jun, 2024 Granted 02 Jul, 2034
{"application_id":"84913","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"fedd7e26e7a3466ea267","publication_number":"US10828294B2","cleaned_patent_number":"10828294","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-02","publication_date":"2020-11-10","legal_status":"Expired"} US10828294B2 10 Nov, 2020 Expired 02 Jul, 2034
{"application_id":"84872","ingredient":"BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE","trade_name":"CONTRAVE","family_id":"fedd7e26e7a3466ea267","publication_number":"US10231964B2","cleaned_patent_number":"10231964","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-07-02","publication_date":"2019-03-19","legal_status":"Expired"} US10231964B2 19 Mar, 2019 Expired 02 Jul, 2034

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