NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 4 pharmaceutical companies such as MSD SUB MERCK, MERCK SHARP DOHME, HETERO LABS LTD III and others. It is marketed under 4 brand names, including ISENTRESS, DUTREBIS, ISENTRESS HD and others. Available in 6 different strengths, such as EQ 25MG BASE, EQ 100MG BASE, EQ 100MG BASE/PACKET and others, and administered through 3 routes including TABLET, CHEWABLE;ORAL, POWDER;ORAL, 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":"112160","ingredient":"RALTEGRAVIR POTASSIUM","trade_name":"ISENTRESS","family_id":"f37ee94825c548a6b2b0","publication_number":"US8852632B2","cleaned_patent_number":"8852632","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-01-28","publication_date":"2014-10-07","legal_status":"Patented case"} | US8852632B2 Molecular Formulation | 07 Oct, 2014 | Patented case | 28 Jan, 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":"112001","ingredient":"RALTEGRAVIR POTASSIUM","trade_name":"ISENTRESS","family_id":"0a647f70df7f464aabfd","publication_number":"US8771733B2","cleaned_patent_number":"8771733","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2030-06-02","publication_date":"2014-07-08","legal_status":"Patented case"} | US8771733B2 Molecular Formulation | 08 Jul, 2014 | Patented case | 02 Jun, 2030 | |
| {"application_id":"94786","ingredient":"RALTEGRAVIR POTASSIUM","trade_name":"ISENTRESS HD","family_id":"ef81ba29946843b89e29","publication_number":"US9649311B2","cleaned_patent_number":"9649311","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-04-21","publication_date":"2017-05-16","legal_status":"Granted"} | US9649311B2 | 16 May, 2017 | Granted | 21 Apr, 2031 | |
| {"application_id":"94759","ingredient":"RALTEGRAVIR POTASSIUM","trade_name":"ISENTRESS HD","family_id":"ef81ba29946843b89e29","publication_number":"US10772888B2","cleaned_patent_number":"10772888","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-03-30","publication_date":"2020-09-15","legal_status":"Granted"} | US10772888B2 | 15 Sep, 2020 | Granted | 30 Mar, 2032 |
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.