NDA (New Drug Application)
ANDA (Generic Application)
Track protection status across key markets to assess launch feasibility.
It is formulated by 1 pharmaceutical company such as ABBVIE. It is marketed under 1 brand name, including ORIAHNN (COPACKAGED). Available in 1 different strength, such as EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE, and administered through 1 route including CAPSULE;ORAL.
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FDA approval history for this ingredient
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Key expiration dates for US patents covering this ingredient
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Latest drug strengths approved by FDA
| Strength | Route of Administration | Companies | Latest Approval Date |
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Patents approved by the FDA for the ingredient
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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,ESTRADIOL,NORETHINDRONE ACETATE; 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":"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":"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":"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":"35366","ingredient":"ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; 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,ESTRADIOL,NORETHINDRONE ACETATE; 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 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
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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.