Prescription medicine
Sacubitril and valsartan Brand names: Entresto
Sacubitril and valsartan (Entresto) is a prescription medicine with an FDA approval on record since 2015. FDA's NDC Directory lists it from 27 generic labelers, and pharmacies paid $0.533 per unit (Sacubitril-valsartan 49-51 mg) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $11.56 per Entresto 49 mg-51 mg tablet.
- Generic listed
- Boxed warning
Check it at the source: the sacubitril and valsartan FDA label on DailyMed (effective July 6, 2026, Novartis Pharmaceuticals Corporation); the NDA 207620 record on Drugs@FDA; every sacubitril and valsartan label on DailyMed.
Highlights of the record
FDA label of July 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
FETAL TOXICITY.
When pregnancy is detected, discontinue ENTRESTO as soon as possible (5.1) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus (5.1) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue ENTRESTO as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.
Used for
From the label: indications and usageENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure.
Forms and strengths
- 6 mg / 6 mg
- 15 mg / 16 mg
- 24 mg / 26 mg
- 49 mg / 51 mg
- 51 mg / 49 mg
- 97 mg / 103 mg
Film-coated tablet; tablet; pellet.
On the market
- Earliest approval on file
- July 7, 2015 Entresto, Novartis Pharms Corp; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first May 28, 2024; 16 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 27 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 9, 2036 Entresto tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.533 per unit Sacubitril-valsartan 49-51 mg
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 115,389 through July 30, 2026
What is sacubitril and valsartan used for?
From the label: indications and usageENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1 ) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. […]
Conditions named in the indications of sacubitril and valsartan's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Angiotensin 2 Receptor Blocker and Neprilysin Inhibitor.
Source: FDA drug label (ENTRESTO), Novartis Pharmaceuticals Corporation, effective July 6, 2026 (SPL set 000dc81d-ab91-450c-8eae-8eb74e72296f), via openFDA; the full label on DailyMed
What does the patient leaflet for sacubitril and valsartan say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ENTRESTO or ENTRESTO SPRINKLE?ENTRESTO or ENTRESTO SPRINKLE can harm or cause death to your unborn baby. Talk to your doctor about other ways to treat heart failure if you plan to become pregnant. Tell your doctor right away if you become pregnant during treatment with ENTRESTO or ENTRESTO SPRINKLE.
From the patient leaflet: How should I store ENTRESTO or ENTRESTO SPRINKLE?Store ENTRESTO tablets or ENTRESTO SPRINKLE oral pellets at room temperature between 68°F to 77°F (20°C to 25°C). Protect ENTRESTO tablets or ENTRESTO SPRINKLE oral pellets from moisture. Store bottles of ENTRESTO tablets prepared as an oral suspension at room temperature less than 77°F (25°C) for up to 15 days. Do not refrigerate ENTRESTO tablets prepared as an oral suspension. Keep ENTRESTO, ENTRESTO SPRINKLE and all medicines out of the reach of children.
Source: FDA drug label (ENTRESTO), Novartis Pharmaceuticals Corporation, effective July 6, 2026 (SPL set 000dc81d-ab91-450c-8eae-8eb74e72296f), via openFDA; the full label on DailyMed
Is there a generic for sacubitril and valsartan (Entresto)?
The FDA approved the first generic sacubitril and valsartan on May 28, 2024. 16 generic applications are approved; 16 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sacubitril and valsartan from 27 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 6 patents for Entresto tablets: the compound patent runs to May 27, 2027 (pediatric exclusivity to November 27, 2027), and the last listed entry to May 9, 2036; a patent listed only for Entresto Sprinkle capsules runs to February 2, 2037. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2015 earliest approval on file
- 2024 first generic approved
- 2036 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for sacubitril and valsartan (Entresto)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.533 per unit (Sacubitril-valsartan 49-51 mg), down 54% from $1.17 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Sacubitril-valsartan 49-51 mg (generic)
- Entresto 49 mg-51 mg tablet (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Sacubitril-valsartan 24-26 mg | Generic | $0.499 per unit | n/a | -60% |
| Sacubitril-valsartan 49-51 mg | Generic | $0.533 per unit | n/a | -54% |
| Sacubitril-valsartan 97-103 mg | Generic | $0.592 per unit | n/a | -49% |
| Entresto 24 mg-26 mg tablet | Brand | $11.59 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $347.78 | +3% |
| Entresto 49 mg-51 mg tablet | Brand | $11.56 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $346.82 | +3% |
| Entresto 97 mg-103 mg tablet | Brand | $11.59 per tablet many times the lowest per-tablet cost; NADAC records the price, not why | $347.66 | +3% |
| Entresto sprinkle 15-16 mg plt | Brand | $11.61 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | +3% |
| Entresto sprinkle 6-6 mg pellet | Brand | $11.62 per unit many times the lowest per-tablet cost; NADAC records the price, not why | n/a | n/a |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the sacubitril and valsartan label say about other medicines?
The sacubitril and valsartan label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 14 other medicines name sacubitril and valsartan. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aliskiren | contraindications | Do not administer within 36 hours of switching from or to an ACE inhibitor [see Drug Interactions (7.1)] with concomitant use of aliskiren in patients with diabetes [see Drug Interactions (7.1)] Hypersensitivity to any component. ( 4 ) History of angioedema related to previous ACEi or ARB therapy. … |
| Amiloride | drug interactions | As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)]. |
| Epinephrine | warnings and precautions | Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, administer appropriate therapy, e.g., subcutaneous epinephrine/adrenaline solution 1:1000 (0.3 mL to 0.5 mL) and take measures necessary to ensure maintenance of a patent airway. |
| Lithium | drug interactions | May lead to increased risk of renal impairment. ( 7.3 ) Lithium: Increased risk of lithium toxicity. |
| Spironolactone | drug interactions | As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)]. |
| Triamterene | drug interactions | As with other drugs that block angiotensin II or its effects, concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increases in serum potassium [see Warnings and Precautions (5.5)]. |
Other labels that name sacubitril and valsartan
Source: FDA drug label (ENTRESTO), Novartis Pharmaceuticals Corporation, effective July 6, 2026 (SPL set 000dc81d-ab91-450c-8eae-8eb74e72296f), via openFDA; the full label on DailyMed
What do FAERS reports show for sacubitril and valsartan?
The FDA Adverse Event Reporting System holds 115,389 reports that list sacubitril and valsartan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 14,147 are coded as a death and 20,918 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as sacubitril and valsartan?
17 other medicines are given the same way (oral) and in the same FDA class as sacubitril and valsartan or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Candesartan | Heart failure | 8 labelers | $0.478 per tablet 16 mg tablet | No current entry |
| Carvedilol | Heart failure | 41 labelers | $0.0179 per tablet 6.25 mg tablet | No current entry |
| Spironolactone | Heart failure | 38 labelers | $0.0426 per tablet 25 mg tablet | A presentation being discontinued |
| Hydrochlorothiazide | Heart failure | 44 labelers | $0.0115 per tablet 25 mg tablet | A presentation being discontinued |
| Furosemide | Heart failure | 33 labelers | $0.026 per tablet 20 mg tablet | In shortage |
| Bumetanide | Heart failure | 24 labelers | $0.108 per tablet 1 mg tablet | Resolved |
| Digoxin | Heart failure | 21 labelers | $0.133 per tablet 125 mcg tablet | No current entry |
| Ivabradine | Heart failure | 11 labelers | $0.761 per tablet 5 mg tablet | A presentation being discontinued |
Every medicine labeled for the same conditions as sacubitril and valsartan
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does sacubitril and valsartan compare with medicines for the same use?
1 side-by-side page set sacubitril and valsartan beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to sacubitril and valsartan
- 17 medicines for the same use
- Other ARBs
- the pharmacologic class, with prices and generics
- Sacubitril and valsartan side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other