NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 1 pharmaceutical company such as NOVARTIS. It is marketed under 1 brand name, including LEQVIO. Available in 1 different strength, such as EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML), and administered through 1 route including SOLUTION;SUBCUTANEOUS.
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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":"78303","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"2ebcc2a1f8904131bbf5","publication_number":"US8809292B2","cleaned_patent_number":"8809292","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-10","publication_date":"2014-08-19","legal_status":"Granted"} | US8809292B2 Molecular Formulation | 19 Aug, 2014 | Granted | 10 May, 2027 | |
| {"application_id":"78341","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"2ebcc2a1f8904131bbf5","publication_number":"US8222222B2","cleaned_patent_number":"8222222","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-12-29","publication_date":"2012-07-17","legal_status":"Granted"} | US8222222B2 | 17 Jul, 2012 | Granted | 29 Dec, 2027 | |
| {"application_id":"77231","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"5b7c622bdfe347008dc9","publication_number":"US10131907B2","cleaned_patent_number":"10131907","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-08-24","publication_date":"2018-11-20","legal_status":"Granted"} | US10131907B2 Molecular Formulation | 20 Nov, 2018 | Granted | 24 Aug, 2028 | |
| {"application_id":"77215","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"b5231ff2f0c14a999e1d","publication_number":"US10806791B2","cleaned_patent_number":"10806791","drug_product_flag":"-","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-04","publication_date":"2020-10-20","legal_status":"Granted"} | US10806791B2 Molecular | 20 Oct, 2020 | Granted | 04 Dec, 2028 | |
| {"application_id":"77212","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"b5231ff2f0c14a999e1d","publication_number":"US9370582B2","cleaned_patent_number":"9370582","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-04","publication_date":"2016-06-21","legal_status":"Granted"} | US9370582B2 Molecular Formulation | 21 Jun, 2016 | Granted | 04 Dec, 2028 | |
| {"application_id":"77210","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"b5231ff2f0c14a999e1d","publication_number":"US8828956B2","cleaned_patent_number":"8828956","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2028-12-04","publication_date":"2014-09-09","legal_status":"Granted"} | US8828956B2 Molecular Formulation | 09 Sep, 2014 | Granted | 04 Dec, 2028 | |
| {"application_id":"77207","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"b5231ff2f0c14a999e1d","publication_number":"US8106022B2","cleaned_patent_number":"8106022","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2029-12-12","publication_date":"2012-01-31","legal_status":"Granted"} | US8106022B2 Molecular Formulation | 31 Jan, 2012 | Granted | 12 Dec, 2029 | |
| {"application_id":"78257","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"3c6880ca0f81429b9289","publication_number":"US10125369B2","cleaned_patent_number":"10125369","drug_product_flag":"Y","drug_substance_flag":"Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2034-08-18","publication_date":"2018-11-13","legal_status":"Granted"} | US10125369B2 Molecular Formulation | 13 Nov, 2018 | Granted | 18 Aug, 2034 | |
| {"application_id":"78354","ingredient":"INCLISIRAN SODIUM","trade_name":"LEQVIO","family_id":"286d32700d8d4c14a0ff","publication_number":"US10851377B2","cleaned_patent_number":"10851377","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-08-25","publication_date":"2020-12-01","legal_status":"Granted"} | US10851377B2 | 01 Dec, 2020 | Granted | 25 Aug, 2036 |
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.