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 | 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.
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 |
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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 |
| |||
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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| United States |
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| Canada |
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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 |
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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 |
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| United States |
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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 |
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| United States |
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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 |
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| United States |
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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 |