Sacubitril; Valsartan Patent Expiration
Sacubitril; Valsartan is Used for treating heart failure with reduced ejection fraction in patients not taking ACE inhibitors or ARBs, or previously on low doses, by titrating up from half the usual starting dose. It was first introduced by Novartis Pharmaceuticals Corp
Sacubitril; Valsartan Patents
Given below is the list of patents protecting Sacubitril; Valsartan, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Entresto Sprinkle | US10722471 | Galenic formulations of organic compounds | Feb 02, 2037 | Novartis |
| Entresto | US11058667 | Sacubitril-valsartan dosage regimen for treating heart failure | May 09, 2036 | Novartis Pharms Corp |
| Entresto | US11135192 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling | Aug 22, 2033 | Novartis Pharms Corp |
| Entresto | US9517226 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling | Aug 22, 2033 | Novartis Pharms Corp |
| Entresto | US9937143 | Inhibitors for treating diseases characterized by atrial enlargement or remodeling | Aug 22, 2033 | Novartis Pharms Corp |
| Entresto |
US8877938 (Pediatric) | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | Nov 27, 2027 | Novartis Pharms Corp |
| Entresto | US8877938 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | May 27, 2027 | Novartis Pharms Corp |
| Entresto Sprinkle | US8877938 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | May 27, 2027 | Novartis |
| Entresto |
US9388134 (Pediatric) | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | May 08, 2027 | Novartis Pharms Corp |
| Entresto | US9388134 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | Nov 08, 2026 | Novartis Pharms Corp |
| Entresto Sprinkle | US9388134 | Compounds containing S-N-valeryl-N-{[2′-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations | Nov 08, 2026 | Novartis |
| Entresto |
US8101659 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul 15, 2025
(Expired) | Novartis Pharms Corp |
| Entresto | US8101659 | Methods of treatment and pharmaceutical composition |
Jan 15, 2025
(Expired) | Novartis Pharms Corp |
| Entresto Sprinkle | US8101659 | Methods of treatment and pharmaceutical composition |
Jan 15, 2025
(Expired) | Novartis |
| Entresto |
US7468390 (Pediatric) | Methods of treatment and pharmaceutical composition |
May 27, 2024
(Expired) | Novartis Pharms Corp |
| Entresto | US7468390 | Methods of treatment and pharmaceutical composition |
Nov 27, 2023
(Expired) | Novartis Pharms Corp |
| Entresto |
US8404744 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul 14, 2023
(Expired) | Novartis Pharms Corp |
| Entresto |
US8796331 (Pediatric) | Methods of treatment and pharmaceutical composition |
Jul 14, 2023
(Expired) | Novartis Pharms Corp |
| Entresto | US8404744 | Methods of treatment and pharmaceutical composition |
Jan 14, 2023
(Expired) | Novartis Pharms Corp |
| Entresto | US8796331 | Methods of treatment and pharmaceutical composition |
Jan 14, 2023
(Expired) | Novartis Pharms Corp |
Sacubitril; Valsartan's Family Patents
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Clinical Trials
Recent Clinical Trials on Sacubitril; Valsartan:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry. Sacubitril; Valsartan has 1 clinical trial that has been verified in 2024. Out of these 1, 1 trial is in PHASE4.