Doxepin Hydrochloride Global Patent Coverage & Expiry Overview

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It is formulated by 25 pharmaceutical companies such as CURRAX, ACTAVIS ELIZABETH, RK PHARMA and others. It is marketed under 2 brand names, including SILENOR, DOXEPIN HYDROCHLORIDE. Available in 9 different strengths, such as EQ 6MG BASE, EQ 3MG BASE, EQ 100MG BASE and others, and administered through 3 routes including TABLET;ORAL, CAPSULE;ORAL, CREAM;TOPICAL.

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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":"99263","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US10238620B2","cleaned_patent_number":"10238620","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-18","publication_date":"2019-03-26","legal_status":"Patented case"} US10238620B2 26 Mar, 2019 Patented case 18 May, 2027
{"application_id":"99261","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US9861607B2","cleaned_patent_number":"9861607","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-18","publication_date":"2018-01-09","legal_status":"Granted"} US9861607B2 09 Jan, 2018 Granted 18 May, 2027
{"application_id":"99266","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US10653662B2","cleaned_patent_number":"10653662","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-18","publication_date":"2020-05-19","legal_status":"Granted"} US10653662B2 19 May, 2020 Granted 18 May, 2027
{"application_id":"99258","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US9486437B2","cleaned_patent_number":"9486437","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-18","publication_date":"2016-11-08","legal_status":"Patented case"} US9486437B2 08 Nov, 2016 Patented case 18 May, 2027
{"application_id":"99281","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US20200345680A1","cleaned_patent_number":"12083090","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-18","publication_date":"2024-09-10","legal_status":"Pending"} US12083090B2 10 Sep, 2024 Pending 18 May, 2027
{"application_id":"99295","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"763546b71f884fc88833","publication_number":"US10653660B2","cleaned_patent_number":"10653660","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-20","publication_date":"2020-05-19","legal_status":"Granted"} US10653660B2 19 May, 2020 Granted 20 Jul, 2027
{"application_id":"99296","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"763546b71f884fc88833","publication_number":"US11110074B2","cleaned_patent_number":"11110074","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-20","publication_date":"2021-09-07","legal_status":"Patented case"} US11110074B2 07 Sep, 2021 Patented case 20 Jul, 2027
{"application_id":"99294","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"763546b71f884fc88833","publication_number":"US9572814B2","cleaned_patent_number":"9572814","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-07-20","publication_date":"2017-02-21","legal_status":"Granted"} US9572814B2 21 Feb, 2017 Granted 20 Jul, 2027
{"application_id":"99292","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"763546b71f884fc88833","publication_number":"US7915307B2","cleaned_patent_number":"7915307","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-08-24","publication_date":"2011-03-29","legal_status":"Patented case"} US7915307B2 29 Mar, 2011 Patented case 24 Aug, 2027
{"application_id":"99269","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US11234954B2","cleaned_patent_number":"11234954","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-18","publication_date":"2022-02-01","legal_status":"Granted"} US11234954B2 01 Feb, 2022 Granted 18 Jan, 2028
{"application_id":"99302","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"8263c7f9c31b45fc8890","publication_number":"US10548871B2","cleaned_patent_number":"10548871","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-11","publication_date":"2020-02-04","legal_status":"Granted"} US10548871B2 04 Feb, 2020 Granted 11 Apr, 2028
{"application_id":"99306","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"8263c7f9c31b45fc8890","publication_number":"US9907780B2","cleaned_patent_number":"9907780","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-11","publication_date":"2018-03-06","legal_status":"Granted"} US9907780B2 Formulation 06 Mar, 2018 Granted 11 Apr, 2028
{"application_id":"99307","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"8263c7f9c31b45fc8890","publication_number":"US11096920B2","cleaned_patent_number":"11096920","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-11","publication_date":"2021-08-24","legal_status":"Patented case"} US11096920B2 24 Aug, 2021 Patented case 11 Apr, 2028
{"application_id":"99247","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US9107898B2","cleaned_patent_number":"9107898","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-05-01","publication_date":"2015-08-18","legal_status":"Patented case"} US9107898B2 18 Aug, 2015 Patented case 01 May, 2028
{"application_id":"99305","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"8263c7f9c31b45fc8890","publication_number":"US9532971B2","cleaned_patent_number":"9532971","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-06-01","publication_date":"2017-01-03","legal_status":"Granted"} US9532971B2 Formulation 03 Jan, 2017 Granted 01 Jun, 2029
{"application_id":"99256","ingredient":"DOXEPIN HYDROCHLORIDE","trade_name":"SILENOR","family_id":"41025a274e194a369d9b","publication_number":"US8513299B2","cleaned_patent_number":"8513299","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-09-07","publication_date":"2013-08-20","legal_status":"Patented case"} US8513299B2 20 Aug, 2013 Patented case 07 Sep, 2030

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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