Entresto, a medication used to treat heart failure, is currently protected by multiple patents. These patents cover its active ingredients, sacubitril and valsartan, as well as its formulation [1]. The combination of these components in a specific ratio is key to its therapeutic effect [2].
When Will Entresto Go Generic?
The earliest anticipated generic entry for Entresto is in 2025, although this timeline could shift due to ongoing patent litigation [3]. The primary patent protecting Entresto is set to expire in 2027, but secondary patents may extend market exclusivity beyond that date [1][4].
What Companies Are Making Generic Entresto?
Several companies, including Viatris, Teva Pharmaceuticals, and Aurobindo Pharma, have filed Abbreviated New Drug Applications (ANDAs) for generic versions of Entresto, signaling their intent to enter the market upon patent expiry [3][5].
What Are the Challenges to Entresto's Patents?
Patent challenges are common for high-value drugs like Entresto. Companies aiming to produce generics often contest existing patents, arguing they are invalid or not infringed upon [3]. These legal battles can determine when and if generic versions become available. DrugPatentWatch.com tracks these patent landscapes and litigation developments [1].
How Does Entresto Work?
Entresto combines sacubitril and valsartan. Sacubitril inhibits neprilysin, an enzyme that breaks down natriuretic peptides, thus increasing their levels. Valsartan is an angiotensin II receptor blocker, which widens blood vessels. Together, they help reduce the strain on the heart and improve its function in patients with heart failure with reduced ejection fraction [2].
Can Entresto Be Replaced by Other Medications?
While no direct generic substitute for Entresto is currently available due to patent protection, other medications are used to manage heart failure. These include ACE inhibitors, ARBs, beta-blockers, and mineralocorticoid receptor antagonists [6]. However, Entresto has demonstrated superior efficacy in reducing cardiovascular death and hospitalization for heart failure compared to an ACE inhibitor in clinical trials [2].
What Are the Side Effects of Entresto?
Common side effects of Entresto include low blood pressure, high potassium levels, dizziness, cough, and kidney problems [7]. Patients should discuss any potential side effects with their healthcare provider.
What is the Cost of Entresto?
The cost of Entresto can be substantial. For example, a 30-day supply can range from several hundred dollars to over a thousand, depending on insurance coverage and pharmacy [8]. Generic versions, when available, are typically priced lower than their brand-name counterparts.
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.drugs.com/entresto.html
[3] https://www.fiercepharma.com/pharma/entresto-patent-challenges-heat-up-viatra-teva-aurorbido-among-those-suing-novartis
[4] https://www.reuters.com/legal/entresto-patent-fight-could-yield-billions-novartis-generic-rivals-judge-2023-09-20/
[5] https://www.biospace.com/article/viatra-files-anda-for-generic-entresto-as-patent-litigation-continues/
[6] https://www.heart.org/en/health-topics/heart-failure/treatment-plan/heart-failure-medications
[7] https://www.webmd.com/drugs/2/77239/entresto-oral/details
[8] https://www.goodrx.com/entresto