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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. 13 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 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

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.

Title Lead Sponsor Collaborators Status Phases
Efficacy and Safety of Sacubitril/Valsartan Compared With Enalapril on Morbidity, Mortality, and NT-proBNP Change in Patients With CCC Novartis Pharmaceuticals ACTIVE NOT RECRUITING
(Sep, 2024)
 PHASE4
Comparative Effectiveness of Entresto (Sacubitril/Valsartan) Versus ACEi/ARB in de Novo Heart Failure Patients Novartis Pharmaceuticals COMPLETED
(Jul, 2023)
The ENVI Study: Effect of Entresto on Left Ventricular Remodelling on Cardiac MRI University Hospital Southampton NHS Foundation Trust COMPLETED
(Apr, 2023)
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients Novartis Pharmaceuticals COMPLETED
(Mar, 2023)
 PHASE4
Sacubitril/Valsartan vs Lifestyle in Hypertrophic Cardiomyopathy Newcastle University Azienda Ospedaliero-Universitaria Careggi, University Hospital Regensburg, Institute for Cardiovascular Diseases of Vojvodina, University of Belgrade COMPLETED
(Nov, 2022)
 PHASE2
Sacubitril/Valsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM) Silesian Centre for Heart Diseases Medical Research Agency, Poland NOT YET RECRUITING
(Jul, 2022)
 PHASE4
The Bio-Clinical Effects of the (Sacubitril-Valsartan) Combination on Patients With Chronic Heart Failure Amir Safwat COMPLETED
(Jun, 2022)
 PHASE4
Study of Effects of Sacubitril/Valsartan vs. Enalapril on Aortic Stiffness in Patients With Mild to Moderate HF With Reduced Ejection Fraction Novartis Pharmaceuticals COMPLETED
(Mar, 2020)
 PHASE4
Safety and Tolerability During Open-label Treatment With LCZ696 in Patients With CHF and Reduced Ejection Fraction Novartis Pharmaceuticals COMPLETED
(Feb, 2019)
 PHASE3
Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension Novartis Pharmaceuticals COMPLETED
(Oct, 2015)
 PHASE2


Sacubitril; Valsartan Generic API Manufacturers

Several generic applications have been filed for Sacubitril; Valsartan. The first generic version for Sacubitril; Valsartan was by Alembic Pharmaceuticals Ltd and was approved on May 28, 2024. And the latest generic version is by Dr Reddys Laboratories Ltd and was approved on Jan 13, 2025.

Given below is the list of companies who have filed for Sacubitril; Valsartan generic, along with the locations of their manufacturing plants worldwide.


1. 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
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


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd





2. ALKEM LABS LTD

Alkem Laboratories 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 Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MG; 26MG

tablet Prescription ORAL AB Sep 16, 2024
97MG; 103MG

tablet Prescription ORAL AB Sep 16, 2024
49MG; 51MG

tablet Prescription ORAL AB Sep 16, 2024





3. BIOCON PHARMA

Biocon Pharma 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 Biocon Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MG; 26MG

tablet Prescription ORAL AB Aug 30, 2024
97MG; 103MG

tablet Prescription ORAL AB Aug 30, 2024
49MG; 51MG

tablet Prescription ORAL AB Aug 30, 2024


Manufacturing Plant Locations
New

Biocon Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Biocon Pharma as present at those locations.

Country City Firm Name
India
Bengaluru Biocon Pharma Limited





4. 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
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


Manufacturing Plant Locations
New

Crystal's manufacturing plants are situated in 2 countries - United States, Canada. Given below are the details of these plant locations as well as the firm names of Crystal as present at those locations.

Country City Firm Name
United States
Tulsa Crystal Farms RDC
Green Bay Crystal Bay Seafoods, LLC
Dallas CrystalBraces, LLC.
Lake Mills Crystal Farms Dairy Company
Baltimore Crystal Cove Inc.
North Bellmore Crystal Enterprises U.S.A., Inc.
Bakersfield Crystal Geyser Water Company Inc.
Modesto Crystal Creamery Inc.
Fresno Crystal Creamery Inc
Centreville Crystal Dental lab dba Crystal Dental Design
Sterling Crystal Brook Farm
Weed Crystal Geyser Roxane LLC
Glendale Crystalmark Dental Systems Inc
Osceola Crystal Ball Farms
Mason City Crystal Distribution Services
Marietta Crystal Beverages Co Inc
Hillman Crystal Creek Farm, Inc
North Liberty Crystal Clear of Iowa City
Kearny Crystal Beverage Corp.
Como Crystal Feed Mills, Inc
Bradenton Crystal Berarducci, DVM
Calistoga Crystal Geyser Water Company
Stockton Crystal Creamery Inc
Blue Bell Crystal Beauty, Inc.
Floral Park Crystal Cove Seafood Corp.
Le Sueur Crystal Farms Dairy Company
Shohola Crystal Clear Water LLC
New Bedford Crystal Ice Co., Inc
Lutz Crystal Care International Inc
Morehead City Crystal Coast Dayboat Seafood Company, LLC
Sunland Crystal Galaxy, Inc
Warsaw Crystal Lake, LLC
Canada
Scarborough Crystal Claire Cosmetics Inc.





5. DR REDDYS

Dr Reddys Laboratories 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 Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
97MG; 103MG

tablet Prescription ORAL AB Jan 13, 2025
24MG; 26MG

tablet Prescription ORAL AB Jan 13, 2025
49MG; 51MG

tablet Prescription ORAL AB Jan 13, 2025





6. 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


Manufacturing Plant Locations
New

Laurus's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Laurus as present at those locations.

Country City Firm Name
India
Hyderabad Laurus Labs Limited
Anakapalli Laurus Labs Limited
Anikapalli District Laurus Labs Limited
Visakhapatnam Laurus Labs Limited
Anakapalli Laurus Labs Limited (Unit-5)





7. LUPIN

Lupin 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 Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
24MG; 26MG

tablet Prescription ORAL AB Jan 8, 2025
49MG; 51MG

tablet Prescription ORAL AB Jan 8, 2025
97MG; 103MG

tablet Prescription ORAL AB Jan 8, 2025


Manufacturing Plant Locations
New

Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.

Country City Firm Name
India
Mumbai Lupin Limited
Pithampur Lupin Limited
Aurangabad Lupin Ltd.
Pune Lupin Bioresearch Center
Nagpur Lupin Limited
Mandideep Lupin Limited
Pithampur Lupin Limited (Unit 1)
Anakapalli District Lupin Manufacturing Solutions Limited
Tarapur, Thane Lupin Limited
Vasco Da Gama Lupin Limited
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Navi Mumbai LUPIN LIMITED
Mandideep Lupin Limited (Unit II)
Pirangut Lupin Limited
United States
Coral Springs Lupin Research Inc
Baltimore Lupin Pharmaceuticals Inc.





8. MACLEODS PHARMS LTD

Macleods 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 Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
49MG; 51MG

tablet Prescription ORAL AB Oct 16, 2024
24MG; 26MG

tablet Prescription ORAL AB Oct 16, 2024
97MG; 103MG

tablet Prescription ORAL AB Oct 16, 2024





9. MSN

Msn Laboratories Private 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 Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
97MG; 103MG

tablet Prescription ORAL AB Jul 24, 2024
49MG; 51MG

tablet Prescription ORAL AB Jul 24, 2024
24MG; 26MG

tablet Prescription ORAL AB Jul 24, 2024


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Sangareddy MSN Pharmachem Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Yadadri Bhuvanagiri District MSN Organics Private Limited
Kamareddy MSN Life Sciences Private Limited
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
Isnapur MSN Laboratories Private Limited, Unit-II
Rangareddy District MSN Laboratories Private Limited
Sangareddy MSN Laboratories Private Ltd.
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Medak MSN LIFE SCIENCES PRIVATE LIMITED
United States
Piscataway MSN PHARMACEUTICALS INC





10. TORRENT

Torrent 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 Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
49MG; 51MG

tablet Prescription ORAL AB Aug 22, 2024
24MG; 26MG

tablet Prescription ORAL AB Aug 22, 2024
97MG; 103MG

tablet Prescription ORAL AB Aug 22, 2024


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Indrad Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
United States
Kalamazoo Torrent Pharma Inc.
Basking Ridge Torrent Pharma Inc.





11. 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
24MG; 26MG

tablet Prescription ORAL AB Jul 9, 2024
97MG; 103MG

tablet Prescription ORAL AB Jul 9, 2024
49MG; 51MG

tablet Prescription ORAL AB Jul 9, 2024