NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as JANSSEN PRODS, GILEAD SCIENCES INC, VIIV HLTHCARE and others. It is marketed under 6 brand names, including EDURANT, COMPLERA, ODEFSEY and others. Available in 5 different strengths, such as EQ 25MG BASE, 200MG;EQ 25MG BASE;300MG, 200MG;EQ 25MG BASE;EQ 25MG BASE and others, and administered through 2 routes including TABLET;ORAL, TABLET, FOR SUSPENSION;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":"37519","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"ODEFSEY","family_id":"0602d214c76a4d1d9d0b","publication_number":"US7390791B2","cleaned_patent_number":"7390791","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-07","publication_date":"2008-06-24","legal_status":"Expired"} | US7390791B2 | 24 Jun, 2008 | Expired | 07 Jul, 2025 | |
| {"application_id":"41499","ingredient":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","trade_name":"COMPLERA","family_id":"bec81101a40c4b6eab8d","publication_number":"US7125879B2","cleaned_patent_number":"7125879","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-10-21","publication_date":"2006-10-24","legal_status":"Expired"} | US7125879B2 | 24 Oct, 2006 | Expired | 21 Oct, 2025 | |
| {"application_id":"41671","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"COMPLERA","family_id":"bec81101a40c4b6eab8d","publication_number":"US8841310B2","cleaned_patent_number":"8841310","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-12-09","publication_date":"2014-09-23","legal_status":"Granted"} | US8841310B2 Formulation | 23 Sep, 2014 | Granted | 09 Dec, 2025 | |
| {"application_id":"34725","ingredient":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","trade_name":"JULUCA","family_id":"c014e2ce75fb4d1a82ea","publication_number":"US8129385B2","cleaned_patent_number":"8129385","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-04-05","publication_date":"2012-03-06","legal_status":"Granted"} | US8129385B2 | 06 Mar, 2012 | Granted | 05 Apr, 2028 | |
| {"application_id":"34964","ingredient":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","trade_name":"JULUCA","family_id":"8091c25130dd42519a5f","publication_number":"US9242986B2","cleaned_patent_number":"9242986","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-08","publication_date":"2016-01-26","legal_status":"Granted"} | US9242986B2 | 26 Jan, 2016 | Granted | 08 Jun, 2030 | |
| {"application_id":"35292","ingredient":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","trade_name":"JULUCA","family_id":"612f6194820245db9a7c","publication_number":"US10426780B2","cleaned_patent_number":"10426780","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-24","publication_date":"2019-10-01","legal_status":"Granted"} | US10426780B2 Molecular Formulation | 01 Oct, 2019 | Granted | 24 Jan, 2031 | |
| {"application_id":"91649","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"COMPLERA","family_id":"0e67c12e1ac142d89ddc","publication_number":"US10857102B2","cleaned_patent_number":"10857102","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-01-14","publication_date":"2020-12-08","legal_status":"Granted"} | US10857102B2 Formulation | 08 Dec, 2020 | Granted | 14 Jan, 2033 | |
| {"application_id":"91044","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"ODEFSEY","family_id":"edf7e71302324e0ea5cb","publication_number":"US8754065B2","cleaned_patent_number":"8754065","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-15","publication_date":"2014-06-17","legal_status":"Granted"} | US8754065B2 | 17 Jun, 2014 | Granted | 15 Feb, 2033 | |
| {"application_id":"90997","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"ODEFSEY","family_id":"edf7e71302324e0ea5cb","publication_number":"US9296769B2","cleaned_patent_number":"9296769","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-02-15","publication_date":"2016-03-29","legal_status":"Granted"} | US9296769B2 | 29 Mar, 2016 | Granted | 15 Feb, 2033 | |
| {"application_id":"123313","ingredient":"RILPIVIRINE HYDROCHLORIDE","trade_name":"EDURANT PED","family_id":"","publication_number":"US11065198B2","cleaned_patent_number":"11065198","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-10-23","publication_date":"2021-07-20","legal_status":"Granted"} | US11065198B2 Formulation | 20 Jul, 2021 | Granted | 23 Oct, 2037 | |
| {"application_id":"124071","ingredient":"DOLUTEGRAVIR SODIUM; RILPIVIRINE HYDROCHLORIDE","trade_name":"JULUCA","family_id":"","publication_number":"US12011506B2","cleaned_patent_number":"12011506","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-09-05","publication_date":"2024-06-18","legal_status":"Granted"} | US12011506B2 Formulation | 18 Jun, 2024 | Granted | 05 Sep, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.