The US Federal Trade Commission (FTC) is keeping a close watch on how pharmaceutical companies respond as several blockbuster drugs approach the end of their patent life. The regulator is particularly concerned about practices that could delay the entry of lower-cost generic medicines.

Speaking at the Reuters Pharma USA conference, a senior FTC official said monitoring the impact of upcoming patent expiries is part of the agency’s strong focus on the healthcare sector. The aim is to ensure that competition increases as intended once exclusivity ends, and that consumers benefit from lower prices.

A number of high-revenue drugs are expected to lose patent protection over the next few years. These include widely used therapies such as Merck’s Keytruda, the blood thinner Eliquis marketed by Bristol Myers Squibb and Pfizer, and Johnson & Johnson’s Darzalex. The loss of exclusivity for such medicines is expected to significantly reshape the market.

The FTC has indicated that it is particularly alert to any anti-competitive behaviour that may prevent or delay generic drug entry. Officials have also invited feedback from industry participants, including generic manufacturers and patient groups, to ensure that the system functions as intended under patent laws.

Beyond patent-related strategies, the regulator is also examining mergers and acquisitions in the pharmaceutical sector. According to the agency, certain deals could reduce competition or weaken incentives for innovation, especially if they eliminate potential rivals or pipeline products.

Recent action by the FTC highlights this stance. The agency moved to block a medical technology acquisition, citing concerns over higher costs and slower innovation, which ultimately led to the deal being abandoned.

With a major patent cliff approaching, regulatory scrutiny is expected to remain high. Ensuring timely generic entry, fair pricing, and continued innovation will be key priorities as the pharmaceutical industry navigates this transition.