NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 13 pharmaceutical companies such as MYLAN, AUROBINDO PHARMA, NORVIUM BIOSCIENCE and others. It is marketed under 7 brand names, including EFAVIRENZ, SYMFI LO, SYMFI and others. Available in 7 different strengths, such as 600MG, 100MG, 200MG and others, and administered through 2 routes including TABLET;ORAL, 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":"17910","ingredient":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"ATRIPLA","family_id":"940457088d44438bb489","publication_number":"US9018192B2","cleaned_patent_number":"9018192","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-13","publication_date":"2015-04-28","legal_status":"Patented case"} | US9018192B2 | 28 Apr, 2015 | Patented case | 13 Jun, 2026 | |
| {"application_id":"17883","ingredient":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"ATRIPLA","family_id":"940457088d44438bb489","publication_number":"US9545414B2","cleaned_patent_number":"9545414","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-06-13","publication_date":"2017-01-17","legal_status":"Patented case"} | US9545414B2 Formulation | 17 Jan, 2017 | Patented case | 13 Jun, 2026 | |
| {"application_id":"17881","ingredient":"EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"ATRIPLA","family_id":"940457088d44438bb489","publication_number":"US8598185B2","cleaned_patent_number":"8598185","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-04-28","publication_date":"2013-12-03","legal_status":"Granted"} | US8598185B2 Formulation | 03 Dec, 2013 | Granted | 28 Apr, 2029 |
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.