NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as GILEAD SCIENCES INC. It is marketed under 1 brand name, including BIKTARVY. Available in 2 different strengths, such as EQ 50MG BASE;200MG;EQ 25MG BASE, EQ 30MG BASE;120MG;EQ 15MG BASE, and administered through 1 route including TABLET;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":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","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":"90997","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","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":"91044","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","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":"91139","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"70a2da3a18734b709b70","publication_number":"US9732092B2","cleaned_patent_number":"9732092","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-19","publication_date":"2017-08-15","legal_status":"Granted"} | US9732092B2 Molecular Formulation | 15 Aug, 2017 | Granted | 19 Dec, 2033 | |
| {"application_id":"91049","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"70a2da3a18734b709b70","publication_number":"US9216996B2","cleaned_patent_number":"9216996","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-12-19","publication_date":"2015-12-22","legal_status":"Granted"} | US9216996B2 Molecular Formulation | 22 Dec, 2015 | Granted | 19 Dec, 2033 | |
| {"application_id":"8239","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"0710a506ff2144769f53","publication_number":"US10385067B2","cleaned_patent_number":"10385067","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-06-19","publication_date":"2019-08-20","legal_status":"Granted"} | US10385067B2 | 20 Aug, 2019 | Granted | 19 Jun, 2035 | |
| {"application_id":"37600","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"0710a506ff2144769f53","publication_number":"US9708342B2","cleaned_patent_number":"9708342","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2035-06-19","publication_date":"2017-07-18","legal_status":"Granted"} | US9708342B2 Molecular Formulation | 18 Jul, 2017 | Granted | 19 Jun, 2035 | |
| {"application_id":"35354","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"8e24b6e8f0244ccea3bc","publication_number":"US10548846B2","cleaned_patent_number":"10548846","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-08","publication_date":"2020-02-04","legal_status":"Granted"} | US10548846B2 Formulation | 04 Feb, 2020 | Granted | 08 Nov, 2036 | |
| {"application_id":"109415","ingredient":"BICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE","trade_name":"BIKTARVY","family_id":"8e24b6e8f0244ccea3bc","publication_number":"US11744802B2","cleaned_patent_number":"11744802","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-08","publication_date":"2023-09-05","legal_status":"Granted"} | US11744802B2 Formulation | 05 Sep, 2023 | Granted | 08 Nov, 2036 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
Manufacturing Locations
Unlock access to all suppliers of Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate
Note: Patent expirations and exclusivity timelines are dynamic and may shift based on litigation, regulatory extensions, and maintenance filings. Regular monitoring is advised.