When will Entresto generic be available?

Entresto is a popular brand-name drug used to treat congestive heart failure. It is manufactured and marketed by a Swiss pharmaceutical company, Novartis Pharmaceuticals, with an estimated $2.5 billion in annual sales in 2020 and expected to increase since granted extended indication approval by the FDA.

In 2018, heart failure was mentioned on 379,800 death certificates. Around 6.2 million Americans have heart failure.

Unfortunately for those who are diagnosed with heart failure, there is currently no generic version of Entresto available on the market in the United States, and the manufacturer was recently granted extended indication approval by the FDA which will further delay the release of the first generic alternative medication. Fortunately, there are several options for you to save money on heart failure medication until generic Entresto is available.

What is Entresto (sacubitril/valsartan)?

Entresto (sacubitril/valsartan) is a popular brand-name prescription medication used to treat adults with long-lasting (chronic) heart failure, also known as congestive heart failure, and helps to reduce the risk of cardiovascular death and hospitalization. It is a combination of two medications, sacubitril and valsartan, and is available as a tablet in doses 24/26mg, 49/51mg, and 97/103mg.

Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). These medications work by relaxing blood vessels so that blood is able to flow more easily, making it easier for the heart to pump blood to the body.

The typical starting dose for this medication is 24/26mg.  The valsartan in this medication is more bioavailable than the valsartan in other marketed tablet formulations – 26mg, 51mg, and 103mg of valsartan in this medication are equivalent to 40 mg, 80 mg, and 160 mg of valsartan in other marketed tablet formulations.

Heart failure occurs when your heart muscle doesn’t pump blood as well as it should. This can cause symptoms such as shortness of breath, fatigue, and swelling in your legs and feet. Entresto works better when the heart cannot pump a normal amount of blood to the body.

Entresto belongs to a class of drugs called angiotensin receptor-neprilysin inhibitors (ARNIs). A class of drugs refers to medications that work similarly. They have a similar chemical structure and are often used to treat similar conditions.

Lab and/or medical tests (such as tests for kidney function and potassium levels) should be done while you are taking Entresto.

It was first approved by the FDA in 2015 for the treatment of heart failure in people with reduced ejection fraction (HFrEF), which is when the heart is so weak that it can only pump 40% or less of the blood in the left ventricle, leading to symptoms like breathlessness.

In clinical trials, Entresto demonstrated to help people with HFrEF stay alive and out of the hospital longer. In PARADIGM-HF, the largest heart failure trial ever conducted, ENTRESTO was also proven to be superior to enalapril.

Entresto was recently granted a patent extension by the FDA until 2024 for extended indication approval for heart failure patients with preserved ejection fraction, which means their hearts can pump out more blood but still less than normal.

What is a generic drug?

A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage, safety, strength, route of administration, quality, and performance characteristics.

Generic drugs are needed for enabling affordable access to essential medications such as Entresto. When Entresto becomes available in generic form, more people will be able to afford the medication.

Patent protection provides an incentive for drug companies to invest in the research and development of new drugs. The patent protection period typically lasts for around 20 years and provides the pharmaceutical company with the exclusivity to sell the medication without any competition. Once a drug’s patent expires, other companies can develop and sell generic versions of the medication.

Generic drugs use the same active ingredients as their brand-name counterparts and FDA requires that they are just as safe and effective.

RELATED: Generic vs brand name drugs

How much will the generic cost?

The price of generic Entresto has not yet been announced. However, the generic will likely be much cheaper than the brand-name drug once it becomes available.

When will generic Entresto become available?

Unfortunately, there is no specific Entresto generic release date that is known at this time. The patent for Entresto was recently extended as a result of an extended indication approval granted by the FDA.

The manufacturer Novartis has been involved in litigation with several generic pharmaceutical companies (including Alkem, Aurobindo, Dr. Reddy’s, Hetero, Laurus, Macleods and Torrent) that would like to start marketing a generic version of Entresto in the United States.

What is an alternative to Entresto?

While there are no generic Entresto alternatives available on the market yet, you can speak to your doctor about the possibility of using other lower-cost medications that are indicated for heart failure.

These are the most prescribed or over-the-counter congestive heart failure medications approved by the Food and Drug Administration (FDA). All of these medications, with the exception of Entresto, have a generic alternative available that may result in significant savings.

Best medications for congestive heart failure

RELATED: Entresto alternatives: which other heart medications can I take?

How do you take Entresto?

Entresto is taken orally in tablet form, usually in combination with other heart failure medications, in place of an ACE inhibitor (such as enalapril or lisinopril) or other ARB.

To reduce the risk of side effects, your prescribing doctor may start you on the low dose of 49/51mg, taken twice daily. Your doctor may gradually increase your dose based on how you respond to the medication and if you experience any side effects.

If you have been prescribed Entresto and are currently taking an ACE inhibitor, you should stop taking your ACE inhibitor, wait for 36 hours, and then start taking Entresto as prescribed.

You should always take Entresto as prescribed by your doctor.

Who can take Entresto?

Do not take this medication if you:

• are allergic to any of its ingredients
• have had an allergic reaction including swelling of your face, lips, tongue, throat (angioedema) or trouble breathing while taking a type of medicine known as an angiotensin-converting enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB)
• are taking an ACE inhibitor medication – you should not take this medication for at least 36 hours before or after you take an ACE inhibitor medicine.
• have diabetes and take a medication that contains aliskiren

Tell your healthcare provider all of the medications you are taking, including prescription drugs, over-the-counter products, herbal supplements, and vitamins. Your doctor will evaluate if there are any possible drug interactions when combining anything else you are taking with Entresto. Tell your healthcare provider if you are taking potassium supplements or a salt substitute, lithium, nonsteroidal anti-inflammatory drugs (NSAIDs), or any other medicines that are used for high blood pressure or heart problems such as an ACE inhibitor, ARB, or aliskiren.

It is not known if Entresto passes into breast milk. Speak with your doctor before breastfeeding.

Side effects of Entresto

The most common side effects of Entresto are:

• low blood pressure
• high potassium
• cough
• dizziness
• kidney problems

Entresto may also cause more serious side effects such as:

• swelling of the face,  tongue, lips, and throat (angioedema) that could cause trouble breathing and possible death
• Black patients or those who have a history of angioedema and take this medication could have a higher risk of having angioedema
• low blood pressure (hypotension)
• kidney problems
• an increased amount of potassium in your blood (hyperkalemia)

This is not a full list of all of the possible side effects of Entresto. You should always seek the medical advice of a licensed healthcare professional for any questions or concerns relating to your medical condition or treatment.

How much does Entresto cost?

In 2022, Novartis provides an estimated list price of $624 per month for those without insurance.

The manufacturer states on its website that Entresto has preferred coverage for more than 99% of Medicare and on average, 80% of people with Medicare Part D pay less than $50 a month out of pocket for their Entresto prescription, and over 50% of people with Medicare Part D pay $10 or less for their Entresto prescription every month.

Novartis also provides a savings card for those with commercial or private insurance that includes a copay offer to pay as little as $10 for a 30-day, 60-day or 90-day supply of Entresto.

It is also recommended to check the manufacturer’s website for the latest terms and requirements.

RELATED: How much does Entresto cost with Medicare?

Why is Entresto so expensive?

Entresto is so expensive because it is a brand-name medication. Brand-name drugs are always more expensive than generic drugs. In contrast, the FDA-approved generic of Entresto will be much cheaper once it becomes available.

How do I save money on Entresto?

Fortunately, there are several options that may help you save money until there is a generic version of Entresto available on the market:

1. Entresto savings card – the manufacturer offers a discount savings card to insured patients who are eligible. Make sure to check the offer on the website as the terms and eligibility requirements can change.
2. Patient assistance programs – find out if you are eligible for enrollment into the Entresto patient assistance program.
3. Ask your prescribing doctor for free samples of Entresto – many pharmaceutical companies provide healthcare providers with free samples to provide to their patients in order to help them get started on the medication.
4. Get medical advice from your healthcare professional and find out if there are any alternative treatment options – there are several lower-cost generic alternatives for Entresto such as lisinopril, carvedilol, valsartan and enalapril that you can discuss with your prescribing doctor.
5. Shop around for the lowest price at multiple mail-order pharmacies – the price for Entresto may vary by pharmacy so you should always check pricing at multiple pharmacies to find the lowest possible price.
6. Entresto coupons – find out if there is an Entresto manufacturer coupon that can help you save money on this medication.
7. Get help from Medicaid – find out if you are eligible for a state Medicaid plan that may cover the cost of Entresto.