Patent Expirations and Market Impact
By analyzing the AdisInsight database, pharmaceutical pipelines, market trends, and emerging developments, we identified several key drugs losing patents in 2025, which will have a major impact on the market. As these patents expire, the availability of generics, and follow-on therapies will rise, making treatments more affordable and accessible while intensifying competition. Generic manufacturers are expected to introduce lower-cost alternatives, driving down prices for high-revenue drugs in areas like cardiovascular care and respiratory disorders. Increased access to generics will particularly benefit emerging markets, spurring growth and improving global health outcomes. However, branded drugmakers may experience revenue declines as generics take market share. To stay competitive, companies will likely focus on innovation, exploring new therapeutic areas, and developing next-generation treatments.
Sacubitril/valsartan (Entresto)
Mechanism of Action: Angiotensin type 1 receptor antagonists; Neprilysin inhibitors Drug class: Small molecules Originator: Novartis Developer: Novartis; Rovi Indication: Essential hypertension; Heart failure; Hypertension Patent expiry: July 2025
Entresto market revenue over ten years (2015-2024)
Entresto has experienced significant growth in recent years. It is now Novartis' best-selling drug, playing a key role in its overall revenue and contributing a large share of its total income. In essence, Entresto is a major contributor to Novartis' financial success. Even though it was approved nearly a decade ago, it continues to generate substantial revenue for the company. Entresto consistently ranks as Novartis' best-selling drug, bringing in a substantial amount of revenue each year. In 2022, Entresto's revenue decline was mainly driven by the increasing threat of generic competition, as multiple companies submitted abbreviated new drug applications (ANDAs) to introduce generic versions of Entresto. This led to legal disputes with Novartis over patent protection and raised concerns about potential sales declines as the market braced for more affordable generic alternatives. The situation was made worse when the FDA rejected Novartis' request to prevent the launch of generic Entresto.
“Entresto remains Novartis' top-selling drug, generating substantial annual revenue.”
How will the patent expiry of Entresto affect the market?
The expiry of Entresto's patent will have a major impact on Novartis' revenue, as it is currently one of their top-selling drugs, accounting for a significant portion of their income. Once the patent expires, other companies can produce generic versions of Entresto, likely leading to a sharp decline in sales as patients switch to more affordable alternatives. This could result in a significant loss of profits for Novartis. In response, Novartis actively engages in legal efforts to protect its patents and delay the release of generic versions. For example, MSN Pharma received US FDA approval for its Entresto generic on July 24, meaning that once the original patent expires, a generic version could be available immediately.