Buprenorphine Global Patent Coverage & Expiry Overview

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It is formulated by 30 pharmaceutical companies such as BARR, PURDUE PHARMA LP, INDIVIOR and others. It is marketed under 12 brand names, including BUPRENORPHINE HYDROCHLORIDE, BUTRANS, SUBOXONE and others. Available in 39 different strengths, such as EQ 2MG BASE, EQ 8MG BASE, 5MCG/HR and others, and administered through 8 routes including TABLET;SUBLINGUAL, FILM, EXTENDED RELEASE;TRANSDERMAL, FILM;BUCCAL, SUBLINGUAL and others.

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Orange Book Drug Approval Timeline

FDA approval history for this ingredient

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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":"115505","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US8545832B2","cleaned_patent_number":"8545832","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-06-06","publication_date":"2013-10-01","legal_status":"Patented case"} US8545832B2 Formulation 01 Oct, 2013 Patented case 06 Jun, 2025
{"application_id":"115504","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US8236755B2","cleaned_patent_number":"8236755","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-07-31","publication_date":"2012-08-07","legal_status":"Patented case"} US8236755B2 Formulation 07 Aug, 2012 Patented case 31 Jul, 2026
{"application_id":"115503","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US8236292B2","cleaned_patent_number":"8236292","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-10","publication_date":"2012-08-07","legal_status":"Granted"} US8236292B2 Formulation 07 Aug, 2012 Granted 10 Jan, 2027
{"application_id":"56358","ingredient":"BUPRENORPHINE HYDROCHLORIDE","trade_name":"BELBUCA","family_id":"663bc864f0f1458588d0","publication_number":"US9655843B2","cleaned_patent_number":"9655843","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-23","publication_date":"2017-05-23","legal_status":"Patented case"} US9655843B2 Formulation 23 May, 2017 Patented case 23 Jul, 2027
{"application_id":"56321","ingredient":"BUPRENORPHINE HYDROCHLORIDE","trade_name":"BELBUCA","family_id":"663bc864f0f1458588d0","publication_number":"US8147866B2","cleaned_patent_number":"8147866","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-23","publication_date":"2012-04-03","legal_status":"Patented case"} US8147866B2 Formulation 03 Apr, 2012 Patented case 23 Jul, 2027
{"application_id":"104584","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"0ac90df20da043e1b0ea","publication_number":"US8658198B2","cleaned_patent_number":"8658198","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-03","publication_date":"2014-02-25","legal_status":"Granted"} US8658198B2 Formulation 25 Feb, 2014 Granted 03 Dec, 2027
{"application_id":"56488","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"SUBOXONE","family_id":"5da595ee007b4b20af58","publication_number":"US11135216B2","cleaned_patent_number":"11135216","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-07","publication_date":"2021-10-05","legal_status":"Granted"} US11135216B2 Formulation 05 Oct, 2021 Granted 07 Aug, 2029
{"application_id":"56487","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"SUBOXONE","family_id":"5da595ee007b4b20af58","publication_number":"US9687454B2","cleaned_patent_number":"9687454","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-08-07","publication_date":"2017-06-27","legal_status":"Granted"} US9687454B2 Formulation 27 Jun, 2017 Granted 07 Aug, 2029
{"application_id":"56459","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"SUBOXONE","family_id":"5da595ee007b4b20af58","publication_number":"US8475832B2","cleaned_patent_number":"8475832","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-03-26","publication_date":"2013-07-02","legal_status":"Granted"} US8475832B2 Formulation 02 Jul, 2013 Granted 26 Mar, 2030
{"application_id":"104594","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"0ac90df20da043e1b0ea","publication_number":"US8470361B2","cleaned_patent_number":"8470361","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-05-22","publication_date":"2013-06-25","legal_status":"Granted"} US8470361B2 Formulation 25 Jun, 2013 Granted 22 May, 2030
{"application_id":"70201","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US10198218B2","cleaned_patent_number":"10198218","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2019-02-05","legal_status":"Granted"} US10198218B2 05 Feb, 2019 Granted 06 Jun, 2031
{"application_id":"70207","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US10592168B1","cleaned_patent_number":"10592168","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2020-03-17","legal_status":"Granted"} US10592168B2 17 Mar, 2020 Granted 06 Jun, 2031
{"application_id":"70198","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US9272044B2","cleaned_patent_number":"9272044","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2016-03-01","legal_status":"Granted"} US9272044B2 01 Mar, 2016 Granted 06 Jun, 2031
{"application_id":"70199","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US9498432B2","cleaned_patent_number":"9498432","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2016-11-22","legal_status":"Granted"} US9498432B2 Formulation 22 Nov, 2016 Granted 06 Jun, 2031
{"application_id":"70200","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US9782402B2","cleaned_patent_number":"9782402","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2017-10-10","legal_status":"Granted"} US9782402B2 Formulation 10 Oct, 2017 Granted 06 Jun, 2031
{"application_id":"70164","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US9827241B2","cleaned_patent_number":"9827241","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-06","publication_date":"2017-11-28","legal_status":"Granted"} US9827241B2 Formulation 28 Nov, 2017 Granted 06 Jun, 2031
{"application_id":"70202","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US10558394B2","cleaned_patent_number":"10558394","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-06-25","publication_date":"2020-02-11","legal_status":"Granted"} US10558394B2 Formulation 11 Feb, 2020 Granted 25 Jun, 2031
{"application_id":"70197","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US8975270B2","cleaned_patent_number":"8975270","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-05","publication_date":"2015-03-10","legal_status":"Granted"} US8975270B2 Formulation 10 Mar, 2015 Granted 05 Sep, 2031
{"application_id":"70196","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"ad66774b3e0845e2a05c","publication_number":"US8921387B2","cleaned_patent_number":"8921387","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-06","publication_date":"2014-12-30","legal_status":"Patented case"} US8921387B2 Formulation 30 Dec, 2014 Patented case 06 Jan, 2032
{"application_id":"115406","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US11110084B2","cleaned_patent_number":"11110084","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-26","publication_date":"2021-09-07","legal_status":"Granted"} US11110084B2 Formulation 07 Sep, 2021 Granted 26 Jul, 2032
{"application_id":"115513","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US10912772B2","cleaned_patent_number":"10912772","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-26","publication_date":"2021-02-09","legal_status":"Granted"} US10912772B2 09 Feb, 2021 Granted 26 Jul, 2032
{"application_id":"115511","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US9937164B2","cleaned_patent_number":"9937164","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-26","publication_date":"2018-04-10","legal_status":"Granted"} US9937164B2 Formulation 10 Apr, 2018 Granted 26 Jul, 2032
{"application_id":"115514","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US11135215B2","cleaned_patent_number":"11135215","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-26","publication_date":"2021-10-05","legal_status":"Granted"} US11135215B2 Formulation 05 Oct, 2021 Granted 26 Jul, 2032
{"application_id":"139383","ingredient":"BUPRENORPHINE","trade_name":"BRIXADI","family_id":"8a513ce750d24a03a577","publication_number":"US12161640B2","cleaned_patent_number":"12161640","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-07-26","publication_date":"2024-12-10","legal_status":"Granted"} US12161640B2 Formulation 10 Dec, 2024 Granted 26 Jul, 2032
{"application_id":"56390","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"BUNAVAIL","family_id":"508e220580b844b6ae42","publication_number":"US8703177B2","cleaned_patent_number":"8703177","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-20","publication_date":"2014-04-22","legal_status":"Granted"} US8703177B2 Formulation 22 Apr, 2014 Granted 20 Aug, 2032
{"application_id":"36002","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US8940330B2","cleaned_patent_number":"8940330","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2015-01-27","legal_status":"Granted"} US8940330B2 Formulation 27 Jan, 2015 Granted 18 Sep, 2032
{"application_id":"36009","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US11020387B2","cleaned_patent_number":"11020387","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2021-06-01","legal_status":"Granted"} US11020387B2 Formulation 01 Jun, 2021 Granted 18 Sep, 2032
{"application_id":"6634","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US9259421B2","cleaned_patent_number":"9259421","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2016-02-16","legal_status":"Granted"} US9259421B2 Formulation 16 Feb, 2016 Granted 18 Sep, 2032
{"application_id":"36003","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US9439900B2","cleaned_patent_number":"9439900","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2016-09-13","legal_status":"Granted"} US9439900B2 Formulation 13 Sep, 2016 Granted 18 Sep, 2032
{"application_id":"6662","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US11433066B2","cleaned_patent_number":"11433066","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2022-09-06","legal_status":"Patented case"} US11433066B2 06 Sep, 2022 Patented case 18 Sep, 2032
{"application_id":"36010","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US11020388B2","cleaned_patent_number":"11020388","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2021-06-01","legal_status":"Granted"} US11020388B2 Formulation 01 Jun, 2021 Granted 18 Sep, 2032
{"application_id":"36008","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US10946010B2","cleaned_patent_number":"10946010","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2021-03-16","legal_status":"Granted"} US10946010B2 Formulation 16 Mar, 2021 Granted 18 Sep, 2032
{"application_id":"36005","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"ZUBSOLV","family_id":"2cfcb11ce8024cf08904","publication_number":"US10874661B2","cleaned_patent_number":"10874661","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-09-18","publication_date":"2020-12-29","legal_status":"Granted"} US10874661B2 Formulation 29 Dec, 2020 Granted 18 Sep, 2032
{"application_id":"56287","ingredient":"BUPRENORPHINE HYDROCHLORIDE","trade_name":"BELBUCA","family_id":"f6f61a734c0942a4b0f8","publication_number":"US9901539B2","cleaned_patent_number":"9901539","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-12-21","publication_date":"2018-02-27","legal_status":"Granted"} US9901539B2 27 Feb, 2018 Granted 21 Dec, 2032
{"application_id":"56376","ingredient":"BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE","trade_name":"BUNAVAIL","family_id":"2f3194bfee564ee5a057","publication_number":"US9522188B2","cleaned_patent_number":"9522188","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-04-24","publication_date":"2016-12-20","legal_status":"Granted"} US9522188B2 Formulation 20 Dec, 2016 Granted 24 Apr, 2035
{"application_id":"120754","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"67a529cfdb9d4f43aac4","publication_number":"US11839611B2","cleaned_patent_number":"11839611","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-06","publication_date":"2023-12-12","legal_status":"Granted"} US11839611B2 12 Dec, 2023 Granted 06 Nov, 2035
{"application_id":"70222","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"67a529cfdb9d4f43aac4","publication_number":"US11000520B2","cleaned_patent_number":"11000520","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-11-06","publication_date":"2021-05-11","legal_status":"Granted"} US11000520B2 11 May, 2021 Granted 06 Nov, 2035
{"application_id":"70208","ingredient":"BUPRENORPHINE","trade_name":"SUBLOCADE","family_id":"f35e306990184176b9ef","publication_number":"US10646484B2","cleaned_patent_number":"10646484","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-06-22","publication_date":"2020-05-12","legal_status":"Granted"} US10646484B2 12 May, 2020 Granted 22 Jun, 2038

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