NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 28 pharmaceutical companies such as CHARTWELL RX, AUROBINDO PHARMA LTD, APOTEX and others. It is marketed under 16 brand names, including LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE, ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE and others. Available in 17 different strengths, such as 150MG;300MG, 300MG, 150MG and others, and administered through 3 routes including TABLET;ORAL, SOLUTION;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":"34725","ingredient":"ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE","trade_name":"DOVATO","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":"69149","ingredient":"LAMIVUDINE; RALTEGRAVIR POTASSIUM","trade_name":"DUTREBIS","family_id":"68bf6e550d0343e49e06","publication_number":"US7754731B2","cleaned_patent_number":"7754731","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-09-11","publication_date":"2010-07-13","legal_status":"Patented case"} | US7754731B2 | 13 Jul, 2010 | Patented case | 11 Sep, 2029 | |
| {"application_id":"34964","ingredient":"ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE","trade_name":"DOVATO","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":"6063","ingredient":"DOLUTEGRAVIR SODIUM; LAMIVUDINE","trade_name":"DOVATO","family_id":"612f6194820245db9a7c","publication_number":"US11234985B2","cleaned_patent_number":"11234985","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-01-24","publication_date":"2022-02-01","legal_status":"Granted"} | US11234985B2 Formulation | 01 Feb, 2022 | Granted | 24 Jan, 2031 | |
| {"application_id":"92304","ingredient":"DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"DELSTRIGO","family_id":"ceb667c21ffa432aa1c0","publication_number":"US8486975B2","cleaned_patent_number":"8486975","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-08-30","publication_date":"2013-07-16","legal_status":"Granted"} | US8486975B2 Molecular Formulation | 16 Jul, 2013 | Granted | 30 Aug, 2032 | |
| {"application_id":"92373","ingredient":"DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"DELSTRIGO","family_id":"86eaa603bd5740b29e1e","publication_number":"US10603282B2","cleaned_patent_number":"10603282","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-29","publication_date":"2020-03-31","legal_status":"Granted"} | US10603282B2 Formulation | 31 Mar, 2020 | Granted | 29 Nov, 2036 | |
| {"application_id":"92393","ingredient":"DORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE","trade_name":"DELSTRIGO","family_id":"86eaa603bd5740b29e1e","publication_number":"US10842751B2","cleaned_patent_number":"10842751","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-11-29","publication_date":"2020-11-24","legal_status":"Granted"} | US10842751B2 Formulation | 24 Nov, 2020 | Granted | 29 Nov, 2036 |
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.