Buprenorphine Hydrochloride Global Patent Coverage & Expiry Overview

Track protection status across key markets to assess launch feasibility.

It is formulated by 25 pharmaceutical companies such as BARR, INDIVIOR, ETHYPHARM and others. It is marketed under 8 brand names, including BUPRENORPHINE HYDROCHLORIDE, SUBOXONE, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE and others. Available in 25 different strengths, such as EQ 2MG BASE, EQ 8MG BASE, EQ 2MG BASE;EQ 0.5MG BASE and others, and administered through 6 routes including TABLET;SUBLINGUAL, FILM;BUCCAL, SUBLINGUAL, FILM;BUCCAL 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":"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":"Patented case"} US9687454B2 Formulation 27 Jun, 2017 Patented case 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":"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":"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":"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":"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":"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":"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":"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":"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":"Patented case"} US9259421B2 Formulation 16 Feb, 2016 Patented case 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":"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

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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