The pharmaceutical industry’s looming ‘patent cliff’ is often framed as a Wall Street problem: Blockbuster drugs lose intellectual property protection, making room for generics to enter and causing company revenues to fall. But for patients, including college students who rely on family insurance, use prescription drugs themselves or are preparing to enter healthcare and biotech careers, the patent cliff is really a test of whether the healthcare system can turn the end of monopoly protection into lower costs and better access.
A U.S. utility patent generally lasts 20 years from the date the application is filed, but patents are only one layer of protection. The Federal Drug Administration also grants regulatory exclusivities, and the agency notes that patents and exclusivities may not run concurrently or cover the same claims. As a result, the patent cliff represents a broader phenomenon rather than a single expiration date. As patents expire, drugs lose protection and competition re-enters the picture. That moment is now approaching for some of the industry’s biggest products.
Reuters reported in February that Merck is restructuring around the coming loss of exclusivity for Keytruda, the best-selling prescription drug in the world, whose key patents begin to expire in 2028. Keytruda generated more than $30 billion in 2025 and accounted for nearly half of Merck’s total revenue. Merck has also been reshaping its business ahead of that deadline, with plans to create a separate oncology business, underscoring how seriously major drugmakers are treating the wave of upcoming loss-of-exclusivity events.
For students, this matters in at least two ways. First, it affects the cost of care. The FDA states that biosimilars have the same treatment risks and benefits as their reference biologics, and that biosimilar approval can expand treatment options and potentially lower costs. This is especially significant because many of the drugs nearing or entering loss-of-exclusivity periods treat conditions that touch families everywhere, including cancer, autoimmune disease and Type 2 diabetes. When competition works, the patent cliff can reduce what patients pay at the pharmacy counter or ensure insurance premiums over time. But when the system fails, the end of intellectual property protection does not automatically translate into affordability.
Recent events make that clear. Reuters reported in February 2026 that CVS Caremark would drop Amgen’s Prolia from certain preferred drug lists starting April 1, 2026, and replace it with lower-cost biosimilar options after Prolia’s U.S. patent expired in 2025. CVS said those changes would cut prescription costs by more than 50%. Reuters also reported that similar formulary shifts around Humira biosimilars produced a 96% switch rate among users in CVS’s program, suggesting that lower-cost alternatives don’t spread through the market automatically based on their lower price. Instead, uptake depends heavily on how insurers and pharmacy benefit managers structure coverage. As GoodRx executive Dorothy Gemmel said in an interview with Reuters, biosimilars “are meant to help improve affordability and access. And the penetration has been very, very slow.” The patent cliff, then, creates the possibility of savings, but intermediaries often determine whether patients actually feel them.
For Tufts students, this issue matters beyond the prescriptions that we or our families may fill. Many students on this campus are preparing for careers in medicine, biotech, consulting, finance and public health, fields where the patent cliff is already reshaping major decisions. For students interested in how therapies actually reach patients, it is also a reminder that what expands access is not the science alone, but the system that determines whether competition leads to medicines that people can actually afford.
The patent cliff, then, shouldn’t be understood only as a threat to pharmaceutical revenue, but also as a public test. If competition after loss of exclusivity lowers prices and widens access, patients win. If companies adapt but insurers, pharmacy benefit managers and delivery systems fail to pass those savings through, then the cliff changes balance sheets more than lives.
