NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as VIIV HLTHCARE. It is marketed under 3 brand names, including CABENUVA KIT, VOCABRIA, APRETUDE. Available in 4 different strengths, such as 400MG/2ML (200MG/ML);600MG/2ML (300MG/ML), 600MG/3ML (200MG/ML);900MG/3ML (300MG/ML), EQ 30MG BASE and others, and administered through 2 routes including SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR, 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 |
|---|
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":"CABOTEGRAVIR; RILPIVIRINE","trade_name":"CABENUVA KIT","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":"34733","ingredient":"CABOTEGRAVIR","trade_name":"APRETUDE","family_id":"c014e2ce75fb4d1a82ea","publication_number":"US10927129B2","cleaned_patent_number":"10927129","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-28","publication_date":"2021-02-23","legal_status":"Granted"} | US10927129B2 Molecular Formulation | 23 Feb, 2021 | Granted | 28 Apr, 2026 | |
| {"application_id":"1347","ingredient":"CABOTEGRAVIR","trade_name":"APRETUDE","family_id":"c014e2ce75fb4d1a82ea","publication_number":"US8410103B2","cleaned_patent_number":"8410103","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2026-04-28","publication_date":"2013-04-02","legal_status":"Patented case"} | US8410103B2 Molecular Formulation | 02 Apr, 2013 | Patented case | 28 Apr, 2026 | |
| {"application_id":"105721","ingredient":"CABOTEGRAVIR; RILPIVIRINE","trade_name":"CABENUVA KIT","family_id":"937f6f2dbad3414fa3c2","publication_number":"US11389447B2","cleaned_patent_number":"11389447","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-06-30","publication_date":"2022-07-19","legal_status":"Patented case"} | US11389447B2 | 19 Jul, 2022 | Patented case | 30 Jun, 2027 | |
| {"application_id":"138510","ingredient":"CABOTEGRAVIR","trade_name":"APRETUDE","family_id":"","publication_number":"","cleaned_patent_number":"12138264","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-15","publication_date":"2024-11-12","legal_status":"Patented Case"} | US12138264B2 Formulation | 12 Nov, 2024 | Patented Case | 15 Sep, 2031 | |
| {"application_id":"41466","ingredient":"CABOTEGRAVIR","trade_name":"APRETUDE","family_id":"fdad321cc3034f0cad5c","publication_number":"US11224597B2","cleaned_patent_number":"11224597","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-09-15","publication_date":"2022-01-18","legal_status":"Granted"} | US11224597B2 Formulation | 18 Jan, 2022 | Granted | 15 Sep, 2031 | |
| {"application_id":"139400","ingredient":"CABOTEGRAVIR; RILPIVIRINE","trade_name":"CABENUVA KIT","family_id":"","publication_number":"USRE50189E","cleaned_patent_number":"RE50189","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2031-11-27","publication_date":"2024-10-29","legal_status":"Granted"} | USRE50189E1 | 29 Oct, 2024 | Granted | 27 Nov, 2031 | |
| {"application_id":"164446","ingredient":"CABOTEGRAVIR; RILPIVIRINE","trade_name":"CABENUVA KIT","family_id":"","publication_number":"US11389448B2","cleaned_patent_number":"11389448","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2032-04-13","publication_date":"2022-07-19","legal_status":"Patented Case"} | US11389448B2 Formulation | 19 Jul, 2022 | Patented Case | 13 Apr, 2032 | |
| {"application_id":"139399","ingredient":"CABOTEGRAVIR; RILPIVIRINE","trade_name":"CABENUVA KIT","family_id":"","publication_number":"US12178815B2","cleaned_patent_number":"12178815","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2038-07-18","publication_date":"2024-12-31","legal_status":"Granted"} | US12178815B2 | 31 Dec, 2024 | Granted | 18 Jul, 2038 |
Latest clinical trials and research studies for this ingredient
| NCT ID | Title | Status | Phase | Conditions | Start Date | Completion Date |
|---|
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.