The pharmaceutical industry is bracing for one of the most significant patent cliffs since 2010, with major blockbuster drugs set to lose market exclusivity between 2025 and 2030. This wave of patent expirations threatens to reshape the competitive landscape as biosimilars and generics enter markets previously dominated by originator companies.
Blockbuster Drugs Face Imminent Patent Expiration
The upcoming patent cliff includes some of the industry's highest-grossing medications. Merck's cancer immunotherapy Keytruda, Bristol Myers Squibb's anticoagulant Eliquis, and Johnson & Johnson's multiple myeloma treatment Darzalex/Faspro are among the top-selling drugs that will lose patent protection during this period. These medications were among the top 15 selling drugs in 2024 but are forecast to generate only a fraction of those sales by 2030.
The financial impact is already materializing for some companies. Johnson & Johnson's autoimmune therapy Stelara, which peaked at nearly $11 billion in global sales in 2023, experienced a $1.2 billion decline in sales during the second quarter of 2025 compared to the same period the previous year, as European and U.S. biosimilars entered the market.
Companies Face Dramatic Revenue Declines
Several of the top 15 pharmaceutical companies will experience substantial financial impacts from the patent cliff. Bristol Myers Squibb, Pfizer, and Novartis are among those companies whose revenue from their top five drugs is projected to decrease by up to 62% by 2030. This dramatic decline underscores the vulnerability of companies heavily dependent on a small number of blockbuster products.
However, not all companies face the same fate. Eli Lilly has strengthened its pipeline sufficiently to offset patent losses, with revenue projected to improve by 165% in 2030, demonstrating the potential for strategic pipeline development to counteract patent cliff impacts.
Current Patent Losses Reveal Industry Challenges
Beyond the upcoming cliff, companies are already grappling with significant patent losses in 2025. Amgen's osteoporosis drug Prolia faces competition from Sandoz's Jubbonti, the first interchangeable biosimilar for the medication. While Prolia sales rose 10% year-over-year to $1.1 billion in the first quarter, Amgen anticipates a drop in the second half of the year as new competitors enter the market.
Regeneron's eye disease treatment Eylea is contending with both biosimilar competition and pressure from Genentech's Vabysmo, a bispecific antibody approved in 2022 that has eroded Eylea's market share. Regeneron has responded by introducing a high-dose version of Eylea and filing lawsuits against several potential competitors, successfully delaying immediate competition from four of five approved biosimilar products.
Strategic Responses to Patent Cliff Pressures
Pharmaceutical companies are employing various mitigation strategies to address patent cliff losses. These approaches include mergers and acquisitions, increased investment in research and development, life cycle management, and the use of patent thickets. Amgen has bolstered its position in rare diseases through acquisitions such as Horizon Therapeutics and by expanding its biosimilar portfolio.
Johnson & Johnson has focused attention on the growth of other immunology drugs, with Tremfya sales increasing 4.9% in the second quarter of 2025, helping to stabilize losses from Stelara's decline.
Launch Strategy Challenges Compound Revenue Pressures
The challenge extends beyond defending existing products to successfully launching new ones. According to EY analysis, up to 67% of drug debuts fail to meet sales targets, representing a critical missed opportunity to offset patent cliff shortfalls. Eduardo Schur, lead for US health sciences and wellness commercial strategy and R&D at EY, noted that "launches have been challenging [and] the adoptions are still slow for a lot of the new technologies and products in the marketplace."
The difficulty stems from changing provider dynamics and heightened payer scrutiny. Traditional marketing approaches are becoming less effective as sales representatives lose easy access to physicians, requiring companies to adopt account-driven strategies that engage entire healthcare systems rather than individual doctors.
Industry Adaptation Required
The patent cliff phenomenon highlights the pharmaceutical industry's need for strategic adaptation. Companies must balance defensive measures to protect existing revenue streams with aggressive investment in innovation and pipeline development. The varying impacts across companies demonstrate that those with diversified portfolios and robust pipelines are better positioned to weather patent expirations.
As Schur emphasized, "pipelines are very rich," suggesting that while the challenges are significant, companies with strong development programs and adaptive marketing strategies can successfully navigate the patent cliff landscape. The key lies in executing comprehensive strategies that address both immediate revenue protection and long-term growth through innovation.
