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 in its drug Entresto on Jul 7, 2015. Another drug containing Sacubitril; Valsartan is Entresto Sprinkle. 6 different companies have introduced drugs containing Sacubitril; Valsartan.


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 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 US7468390 Methods of treatment and pharmaceutical composition Nov 27, 2023

(Expired)

Novartis Pharms Corp
Entresto US7468390

(Pediatric)

Methods of treatment and pharmaceutical composition May 27, 2024

(Expired)

Novartis Pharms Corp
Entresto US8101659 Methods of treatment and pharmaceutical composition Jan 15, 2025 Novartis Pharms Corp
Entresto US8101659

(Pediatric)

Methods of treatment and pharmaceutical composition Jul 15, 2025 Novartis Pharms Corp
Entresto US8404744 Methods of treatment and pharmaceutical composition Jan 14, 2023

(Expired)

Novartis Pharms Corp
Entresto US8404744

(Pediatric)

Methods of treatment and pharmaceutical composition Jul 14, 2023

(Expired)

Novartis Pharms Corp
Entresto US8796331 Methods of treatment and pharmaceutical composition Jan 14, 2023

(Expired)

Novartis Pharms Corp
Entresto US8796331

(Pediatric)

Methods of treatment and pharmaceutical composition Jul 14, 2023

(Expired)

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 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 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 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 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 Sprinkle US10722471 Galenic formulations of organic compounds Feb 02, 2037 Novartis
Entresto Sprinkle US8101659 Methods of treatment and pharmaceutical composition Jan 15, 2025 Novartis
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 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


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Sacubitril; Valsartan Generics

Several generic applications have been filed for Sacubitril; Valsartan. The first generic version for Sacubitril; Valsartan was by Crystal Pharmaceutical Suzhou Co Ltd and was approved on May 28, 2024. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Jul 9, 2024.

Given below is the list of companies who have filed for Sacubitril; Valsartan generic.


1. CRYSTAL

Crystal Pharmaceutical Suzhou Co Ltd has filed for 3 different strengths of generic version for Sacubitril; Valsartan. All of these versions come by the name SACUBITRIL AND VALSARTAN. Given below are the details of the strengths of this generic introduced by Crystal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
49MG; 51MG tablet Prescription ORAL AB May 28, 2024
24MG; 26MG tablet Prescription ORAL AB May 28, 2024
97MG; 103MG tablet Prescription ORAL AB May 28, 2024


2. LAURUS

Laurus Labs Ltd has filed for 3 different strengths of generic version for Sacubitril; Valsartan. All of these versions come by the name SACUBITRIL AND VALSARTAN. Given below are the details of the strengths of this generic introduced by Laurus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MG; 26MG tablet Prescription ORAL AB May 28, 2024
49MG; 51MG tablet Prescription ORAL AB May 28, 2024
97MG; 103MG tablet Prescription ORAL AB May 28, 2024


3. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Sacubitril; Valsartan. All of these versions come by the name SACUBITRIL AND VALSARTAN. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
97MG; 103MG tablet Prescription ORAL AB Jul 9, 2024
24MG; 26MG tablet Prescription ORAL AB Jul 9, 2024
49MG; 51MG tablet Prescription ORAL AB Jul 9, 2024


4. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Sacubitril; Valsartan. All of these versions come by the name SACUBITRIL AND VALSARTAN. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MG; 26MG tablet Prescription ORAL AB May 28, 2024
49MG; 51MG tablet Prescription ORAL AB May 28, 2024
97MG; 103MG tablet Prescription ORAL AB May 28, 2024