Fentanyl Global Patent Coverage & Expiry Overview

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It is formulated by 14 pharmaceutical companies such as WATSON LABS, SENTYNL THERAPS INC, SPECGX LLC and others. It is marketed under 14 brand names, including FENTANYL CITRATE, ABSTRAL, FENTANYL-50 and others. Available in 25 different strengths, such as EQ 0.1MG BASE, EQ 0.8MG BASE, EQ 0.6MG BASE and others, and administered through 7 routes including TABLET;BUCCAL, SUBLINGUAL, TABLET;SUBLINGUAL, FILM, EXTENDED RELEASE;TRANSDERMAL 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

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":"81867","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"cecd31b4a2314023b59c","publication_number":"US10016403B2","cleaned_patent_number":"10016403","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2018-07-10","legal_status":"Expired"} US10016403B2 Formulation 10 Jul, 2018 Expired 25 Jan, 2027
{"application_id":"81841","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"05a5d0dfe4c74cf9bb02","publication_number":"US10610523B2","cleaned_patent_number":"10610523","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2020-04-07","legal_status":"Granted"} US10610523B2 Formulation 07 Apr, 2020 Granted 25 Jan, 2027
{"application_id":"81838","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"05a5d0dfe4c74cf9bb02","publication_number":"US8835459B2","cleaned_patent_number":"8835459","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2014-09-16","legal_status":"Expired"} US8835459B2 Formulation 16 Sep, 2014 Expired 25 Jan, 2027
{"application_id":"81845","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"cecd31b4a2314023b59c","publication_number":"US8835460B2","cleaned_patent_number":"8835460","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2014-09-16","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US8835460B2 Formulation 16 Sep, 2014 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 25 Jan, 2027
{"application_id":"81839","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"05a5d0dfe4c74cf9bb02","publication_number":"US9241935B2","cleaned_patent_number":"9241935","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2016-01-26","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9241935B2 Formulation 26 Jan, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 25 Jan, 2027
{"application_id":"81865","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"cecd31b4a2314023b59c","publication_number":"US9289387B2","cleaned_patent_number":"9289387","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2016-03-22","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9289387B2 Formulation 22 Mar, 2016 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 25 Jan, 2027
{"application_id":"81866","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"cecd31b4a2314023b59c","publication_number":"US9642797B2","cleaned_patent_number":"9642797","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2017-05-09","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9642797B2 Formulation 09 May, 2017 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 25 Jan, 2027
{"application_id":"81840","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"05a5d0dfe4c74cf9bb02","publication_number":"US9642844B2","cleaned_patent_number":"9642844","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-01-25","publication_date":"2017-05-09","legal_status":"Granted"} US9642844B2 Formulation 09 May, 2017 Granted 25 Jan, 2027
{"application_id":"56357","ingredient":"FENTANYL CITRATE","trade_name":"ONSOLIS","family_id":"663bc864f0f1458588d0","publication_number":"US9597288B2","cleaned_patent_number":"9597288","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-23","publication_date":"2017-03-21","legal_status":"Patented case"} US9597288B2 Formulation 21 Mar, 2017 Patented case 23 Jul, 2027
{"application_id":"89005","ingredient":"FENTANYL CITRATE","trade_name":"FENTORA","family_id":"4f0f41afa6c84018a92b","publication_number":"US7862833B2","cleaned_patent_number":"7862833","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-15","publication_date":"2011-01-04","legal_status":"Granted"} US7862833B2 Formulation 04 Jan, 2011 Granted 15 Jun, 2028
{"application_id":"89004","ingredient":"FENTANYL CITRATE","trade_name":"FENTORA","family_id":"4f0f41afa6c84018a92b","publication_number":"US7862832B2","cleaned_patent_number":"7862832","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-06-15","publication_date":"2011-01-04","legal_status":"Granted"} US7862832B2 Formulation 04 Jan, 2011 Granted 15 Jun, 2028
{"application_id":"81829","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"05a5d0dfe4c74cf9bb02","publication_number":"US8486973B2","cleaned_patent_number":"8486973","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-27","publication_date":"2013-07-16","legal_status":"Patented case"} US8486973B2 16 Jul, 2013 Patented case 27 Apr, 2030
{"application_id":"81864","ingredient":"FENTANYL","trade_name":"SUBSYS","family_id":"cecd31b4a2314023b59c","publication_number":"US8486972B2","cleaned_patent_number":"8486972","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-04-27","publication_date":"2013-07-16","legal_status":"Granted"} US8486972B2 Formulation 16 Jul, 2013 Granted 27 Apr, 2030
{"application_id":"83563","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9364656B2","cleaned_patent_number":"9364656","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-30","publication_date":"2016-06-14","legal_status":"Expired"} US9364656B2 14 Jun, 2016 Expired 30 Sep, 2031
{"application_id":"83559","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8301238B2","cleaned_patent_number":"8301238","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-30","publication_date":"2012-10-30","legal_status":"Expired"} US8301238B2 Formulation 30 Oct, 2012 Expired 30 Sep, 2031
{"application_id":"83565","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9731121B2","cleaned_patent_number":"9731121","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-10-17","publication_date":"2017-08-15","legal_status":"Expired"} US9731121B2 Formulation 15 Aug, 2017 Expired 17 Oct, 2031
{"application_id":"81121","ingredient":"FENTANYL CITRATE","trade_name":"LAZANDA","family_id":"2661d1f19c2a4760be9e","publication_number":"US9731869B2","cleaned_patent_number":"9731869","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-01-26","publication_date":"2017-08-15","legal_status":"Granted"} US9731869B2 Formulation 15 Aug, 2017 Granted 26 Jan, 2032
{"application_id":"83561","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8781571B2","cleaned_patent_number":"8781571","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-31","publication_date":"2014-07-15","legal_status":"Expired"} US8781571B2 Formulation 15 Jul, 2014 Expired 31 Mar, 2032
{"application_id":"83560","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8428708B1","cleaned_patent_number":"8428708","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-05-21","publication_date":"2013-04-23","legal_status":"Expired"} US8428708B2 23 Apr, 2013 Expired 21 May, 2032
{"application_id":"83487","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US8428709B1","cleaned_patent_number":"8428709","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-06-11","publication_date":"2013-04-23","legal_status":"Expired"} US8428709B2 Formulation 23 Apr, 2013 Expired 11 Jun, 2032
{"application_id":"83562","ingredient":"FENTANYL HYDROCHLORIDE","trade_name":"IONSYS","family_id":"b1570d9b61bd4d96923b","publication_number":"US9095706B2","cleaned_patent_number":"9095706","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-03","publication_date":"2015-08-04","legal_status":"Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362"} US9095706B2 Formulation 04 Aug, 2015 Patent expired due to nonpayment of maintenance fees under 37 cfr 1.362 03 Feb, 2033

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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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