In the coming years, about 200 drugs will have their patents or terms of exclusivity come to an end. These drugs make up an estimated $400 billion in revenue for the pharma industry. While this isn’t the first patent cliff to hit the industry, it is the largest its ever faced.

Major pharmaceutical companies have been preparing for the cliff, which begins this year and will continue through 2030.

However, due to the volume of drugs impacted and the revenue they account for, it’s unlikely that these companies will avoid impact entirely.

These concerns have steered the strategies for major pharma and biotechs for the past several years. In 2024, Virginia Acha, associate VP and global lead of global evidence and regulatory policy at MSD, spoke at the Financial Times’ Global Pharma and Biotech Summit about Merck’s strategy to deal with the upcoming Keytruda patent expiration.

She said, ““Keytruda has been hugely valuable in oncology. We’re up to 41 different indications, and we’ve consistently and continuously invested in it. The original and subsequent patents have represented that important point around the patent system, which I think represents why patents are so important. It’s a critical way to incentivize innovation and it’s a way to make that bargain, whereby we are able to patent and fully disclose our science that others can also learn and build on that. For a period of time, there’s a protection for that specific technology.”

What drugs are included in the patent cliff?

About 200 drugs will lose their patents or periods of exclusivity in the next 5 years. This includes key assets (or blockbusters) such as:

• Ozempic (2031)
• Keytruda (2028)
• Ibrance (2027)
• Eliquis (2028)
• Cosentyx (2029)
• Trulicity (2027)

What is the impact of the patent cliff?

The term “patent cliff” refers to the steep drop in revenue that comes when a drug’s patent expires or its period of exclusivity ends. Once this happens, competitors can introduce generic versions or biosimilars to the market.

However, it doesn’t necessarily mean that the original drug completely loses its ability to bring in revenue. It does allow for less expensive alternatives to hit the market.

What strategies do pharma and biotech companies have to mitigate the impact of the patent cliff?

Pharma and biotech companies have two primary strategies to combat the patent cliff. The first is to bolster their R&D efforts and attempt to introduce new potential blockbuster drugs to their pipelines.

The second is to attempt to expand the drugs’ indications, thus allowing for potential patent extensions.

However, both options put strain on pharma and biotech companies, as they must interpret the markets and rely heavily on the success of this analysis for new launches.

In a piece written for Pharmaceutical Executive, Nmblr founder and CEO Janice MacLennan discussed these issues. She wrote, “The obvious threat is to revenue, with some brands losing more than 80% of market share in their first-year post-expiry, but beyond loss of exclusivity, drug companies are facing a less obvious challenge. With an unprecedented amount of patent cliffs looming, biopharma organizations are facing a stress test, measuring the effects their cross-functional teams can understand, interpret, and respond to increasingly complex factors, as new assets are introduced to market.”

McLennan continued, “At the same time, innovation pipelines are becoming more crowded, particularly in oncology, inflammation, and neurology, as intensifying competition and differentiation become harder to sustain. Scientific clout continues to remain essential, but it’s not sufficient on its own. The ability to translate innovation into meaningful impact, ensuring therapies are understood, adopted, and valued by patients, providers, and healthcare systems, is the real driving force on the road to peak sales.”

How are pharma and biotech are changing their businesses ahead of the patent cliff?

Thani Jambulingam, Ph.D., is a professor in food, pharma and healthcare at Erivan K. Haub School of Business, Saint Joseph’s University, Philadelphia. In February 2026, he discussed Merck’s strategy ahead of the patent cliff with Pharmaceutical Executive. According to him, Merck’s strategy appears to be focused on avoiding blockbuster drug concentration.

Keytruda’s success reshaped Merck’s business, and the loss of its patent in the patent cliff will put a significant strain on the company’s revenue pipeline. According to Jambulingam, Keytrud accounted for more than half of the company’s pharmaceutical sales in 2025.

“When a single franchise grows large enough,” Jambulingam wrote, “the implications are not limited to portfolio strategy. They extend directly into governance, structure, and leadership architecture.”

He also explained, “Patent cliffs were once managed primarily through pipeline replenishment. Today, mega-blockbusters drive deeper transformation, organizational redesign, governance restructuring, leadership recalibration, and diversification strategies. The winners will not be those who merely predict cliffs, but those who re-architect early enough. Merck’s oncology spin-out underscores a defining reality of modern pharma: molecules may create value, but organizational design increasingly determines how effectively that value is protected, extended, and reinvented.”

What impact is the patent cliff having on earnings projections?

In its 2025 earning’s report, Novartis reported an 8% increase in its net sales. Core operating income also rose about 14%, and earnings-per-share increased about 17%. However, the company did see net sales decline by about 1% in the fourth quarter.

For 2026, the company provided more restrained predictions for growth than in previous years. The company’s CEO Vas Narasimhan attributed this to the coming patent cliff, which will see several of Novartis’ drugs lose their patents. According to him, this will cause significant pressure from generics.

How strong is the biosimilar market heading into the patent cliff?

Pharmaceutical Executive spoke with Thomas Newcomer, senior vice president and head of US commercial at Samsung Bioepi, at what he described as the biosimilar void. According to him, “there's several biosimilar manufacturers at this point in time. We expect a couple more to enter the US market, and that's naturally going to help address some of the issues of the high-priced biologic medicines not having a biosimilar option when they come off patent.”

He continued, “But, if you look at some of the most high-priced biologics, most people would agree there is a biosimilar in the works for those specific products. But it really is the ones in the middle that are causing the void. It may be the ones that don't have a huge dollar volume attached to the originator units right now in the US market. It may be rare diseases that many biosimilar manufacturers have not entered into the space at this point in time from a developmental standpoint, but there absolutely is a void for what's coming off patent in just the next five years.”