NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 2 pharmaceutical companies such as GILEAD SCIENCES INC, MYLAN. It is marketed under 2 brand names, including COMPLERA, EMTRICITABINE, RILPIVIRINE AND TENOFOVIR DISOPROXIL FUMARATE. Available in 1 different strength, such as 200MG;EQ 25MG BASE;300MG, 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":"41499","ingredient":"EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE","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":"2025-04-21","publication_date":"2006-10-24","legal_status":"Expired"} | US7125879B2 Molecular Formulation | 24 Oct, 2006 | Expired | 21 Apr, 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":"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 |
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.