Elagolix Sodium Global Patent Coverage & Expiry Overview

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It is formulated by 1 pharmaceutical company such as ABBVIE. It is marketed under 2 brand names, including ORILISSA, ORIAHNN (COPACKAGED). Available in 3 different strengths, such as EQ 150MG BASE, EQ 200MG BASE, EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE, and administered through 2 routes including TABLET;ORAL, CAPSULE;ORAL.

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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":"35911","ingredient":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"3ba8fe99209e473c8244","publication_number":"US11459305B2","cleaned_patent_number":"11459305","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-11-07","publication_date":"2022-10-04","legal_status":"Granted"} US11459305B2 Formulation 04 Oct, 2022 Granted 07 Nov, 2028
{"application_id":"1608","ingredient":"ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"11ff6f06f529441ca0c2","publication_number":"US7419983B2","cleaned_patent_number":"7419983","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-07-06","publication_date":"2008-09-02","legal_status":"Patented case"} US7419983B2 Molecular Formulation 02 Sep, 2008 Patented case 06 Jul, 2029
{"application_id":"35752","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"c22fcc908fa64c04b77e","publication_number":"US11707464B2","cleaned_patent_number":"11707464","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2023-07-25","legal_status":"Granted"} US11707464B2 25 Jul, 2023 Granted 14 Mar, 2034
{"application_id":"35748","ingredient":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"c22fcc908fa64c04b77e","publication_number":"US10881659B2","cleaned_patent_number":"10881659","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2021-01-05","legal_status":"Granted"} US10881659B2 05 Jan, 2021 Granted 14 Mar, 2034
{"application_id":"35749","ingredient":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"c22fcc908fa64c04b77e","publication_number":"US11045470B2","cleaned_patent_number":"11045470","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2021-06-29","legal_status":"Granted"} US11045470B2 29 Jun, 2021 Granted 14 Mar, 2034
{"application_id":"31404","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"c22fcc908fa64c04b77e","publication_number":"US11344551B2","cleaned_patent_number":"11344551","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-03-14","publication_date":"2022-05-31","legal_status":"Granted"} US11344551B2 31 May, 2022 Granted 14 Mar, 2034
{"application_id":"35368","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"fe0c4dba6f644fa796a1","publication_number":"US10537572B2","cleaned_patent_number":"10537572","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-01","publication_date":"2020-01-21","legal_status":"Granted"} US10537572B2 21 Jan, 2020 Granted 01 Sep, 2036
{"application_id":"35367","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"fe0c4dba6f644fa796a1","publication_number":"US10682351B2","cleaned_patent_number":"10682351","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-09-01","publication_date":"2020-06-16","legal_status":"Granted"} US10682351B2 16 Jun, 2020 Granted 01 Sep, 2036
{"application_id":"1616","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"ef8210eaa5f34138a6c4","publication_number":"US11690854B2","cleaned_patent_number":"11690854","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-04-19","publication_date":"2023-07-04","legal_status":"Granted"} US11690854B2 04 Jul, 2023 Granted 19 Apr, 2038
{"application_id":"1619","ingredient":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"ef8210eaa5f34138a6c4","publication_number":"US20190054027A1","cleaned_patent_number":"12083227","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-20","publication_date":"2019-02-21","legal_status":"Abandoned"} US12083227B2 Formulation 21 Feb, 2019 Abandoned 20 Aug, 2038
{"application_id":"111079","ingredient":"ELAGOLIX SODIUM","trade_name":"ORILISSA","family_id":"ef8210eaa5f34138a6c4","publication_number":"US20230255968A1","cleaned_patent_number":"12102637","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-08-20","publication_date":"2023-08-17","legal_status":"Granted"} US12102637B2 Formulation 17 Aug, 2023 Granted 20 Aug, 2038
{"application_id":"35366","ingredient":"ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"cdffb650ad63467fbf0f","publication_number":"US11542239B2","cleaned_patent_number":"11542239","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2039-07-23","publication_date":"2023-01-03","legal_status":"Granted"} US11542239B2 Molecular Formulation 03 Jan, 2023 Granted 23 Jul, 2039
{"application_id":"37188","ingredient":"ELAGOLIX SODIUM","trade_name":"ORIAHNN (COPACKAGED)","family_id":"2d0b66935dc74d4f9965","publication_number":"US11690845B2","cleaned_patent_number":"11690845","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2040-08-27","publication_date":"2023-07-04","legal_status":"Granted"} US11690845B2 04 Jul, 2023 Granted 27 Aug, 2040

Recent Clinical Trials

Latest clinical trials and research studies for this ingredient

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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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