NDA (New Drug Application)
ANDA (Generic Application)
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It is formulated by 13 pharmaceutical companies such as NOVARTIS PHARMS CORP, NOVARTIS, ALEMBIC and others. It is marketed under 3 brand names, including ENTRESTO, ENTRESTO SPRINKLE, SACUBITRIL AND VALSARTAN. Available in 5 different strengths, such as 24MG;26MG, 49MG;51MG, 97MG;103MG and others, and administered through 2 routes including TABLET;ORAL, CAPSULE, PELLETS;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":"118634","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"a8780bed7ae149fb8719","publication_number":"USPP28213B2","cleaned_patent_number":"8101659","drug_product_flag":"-, Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2025-07-15","publication_date":"2017-07-18","legal_status":"Granted"} | US8101659B2 | 18 Jul, 2017 | Granted | 15 Jul, 2025 | |
| {"application_id":"93065","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"1543222e8e694fd2b538","publication_number":"US9388134B2","cleaned_patent_number":"9388134","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-05-08","publication_date":"2016-07-12","legal_status":"Patented case"} | US9388134B2 | 12 Jul, 2016 | Patented case | 08 May, 2027 | |
| {"application_id":"119082","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"1543222e8e694fd2b538","publication_number":"US8877938B2","cleaned_patent_number":"8877938","drug_product_flag":"-, Y","drug_substance_flag":"-, Y","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2027-11-27","publication_date":"2014-11-04","legal_status":"Granted"} | US8877938B2 | 04 Nov, 2014 | Granted | 27 Nov, 2027 | |
| {"application_id":"92954","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"95b6722bf10843389268","publication_number":"US9937143B2","cleaned_patent_number":"9937143","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-22","publication_date":"2018-04-10","legal_status":"Granted"} | US9937143B2 | 10 Apr, 2018 | Granted | 22 Aug, 2033 | |
| {"application_id":"92922","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"95b6722bf10843389268","publication_number":"US11135192B2","cleaned_patent_number":"11135192","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-22","publication_date":"2021-10-05","legal_status":"Granted"} | US11135192B2 | 05 Oct, 2021 | Granted | 22 Aug, 2033 | |
| {"application_id":"92953","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"95b6722bf10843389268","publication_number":"US9517226B2","cleaned_patent_number":"9517226","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2033-08-22","publication_date":"2016-12-13","legal_status":"Granted"} | US9517226B2 | 13 Dec, 2016 | Granted | 22 Aug, 2033 | |
| {"application_id":"92959","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO","family_id":"3ef3919816af44b9a388","publication_number":"US11058667B2","cleaned_patent_number":"11058667","drug_product_flag":"-","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2036-05-09","publication_date":"2021-07-13","legal_status":"Patented case"} | US11058667B2 | 13 Jul, 2021 | Patented case | 09 May, 2036 | |
| {"application_id":"123295","ingredient":"SACUBITRIL; VALSARTAN","trade_name":"ENTRESTO SPRINKLE","family_id":"","publication_number":"US10722471B2","cleaned_patent_number":"10722471","drug_product_flag":"Y","drug_substance_flag":"-","use_codes":["-"],"definitions":["-"],"patent_expire_date_text":"2037-02-02","publication_date":"2020-07-28","legal_status":"Granted"} | US10722471B2 Formulation | 28 Jul, 2020 | Granted | 02 Feb, 2037 |
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.