Golimumab biosimilar (Alvotech)

The end of the U.S. patent runway is nearing for 10 industry blockbusters in 2025. While each year features high-profile losses of exclusivity in the pharma industry, this year's list is something of a doozy.For one, Johnson & Johnson's Stelara is already facing off against several biosimilars, and several more are yet to come as the year plays out. With $6.72 billion in U.S. sales in 2024, the drug is the largest U.S. loss of exclusivity since AbbVie's megablockbuster Humira tumbled over the patent cliff in early 2023. Johnson & Johnson had previously warned of a "late 2023" patent cliff for Stelara, but the company was able to squeeze more life out of its key immunology moneymaker through a series of legal settlements.Johnson & Johnson's not alone in losing U.S. market exclusivity on a key sales driver this year. Also facing ongoing or future declines for their top revenue generators are Regeneron with eye drug Eylea, Amgen with bone medicines Prolia/Xgeva and Novartis with heart failure therapy Entresto. Eylea already faces its first U.S. biosimilar after Amgen launched Pavblu in November. Fierce Pharma chose to include Eylea in this report—despite the biosimilar launch happening last year—because the commercial situation is still playing out for Regeneron and to not exclude a key development in an important market.Amgen, for its part, collected $4.39 billion in revenue from its key bone medicines Prolia and Xgeva last year. While the company has built its own impressive biosimilar business over the years, it'll have to play an unfamiliar role and watch copycat drugs eat away at the market for its originators starting in late May and early June.Novartis, meanwhile, has warned of a "mid-2025" loss of U.S. exclusivity for Entresto as a key combination patent nears its expiration this summer. Besides Entresto, Novartis has two other big-selling products on this list in Promacta and Tasigna.Moving down the list, readers will likely notice two high-profile drugs from AstraZeneca. Rare disease medicine Soliris, picked up in AZ's buyout of Alexion, is set to face its first biosimilar from Amgen sometime in the second quarter. And Brilinta, a cardiometabolic drug once pegged to be a key blockbuster but that never quite met expectations, is also running out of its U.S. patent protections in the near future.For one measure of the high-profile nature of the drugs on this list, look no further than last year's version of the report. With $1.45 billion in prior-year U.S. sales, Bristol Myers Squibb's Sprycel led the 2024 group. But, if compared against the 2025 class of patent expirations, Sprycel would rank No. 6. There are always uncertainties in compiling this report due to the unpredictable nature of patent litigation and regulatory interactions. This year, the drug with the most apparent uncertainty is J&J's Simponi and Simponi ARIA. That medicine's inclusion hinges on a potential fourth-quarter approval—and launch—of Teva and Alvotech's AVT05. We opted to include the medicine because a key patent has already expired, and a reputable biosimilar team is marching through the regulatory process.To compile this report, Fierce Pharma parsed company filings, presentations and conference call transcripts. We also used published research from pharmacy benefit manager OptumRx and healthcare services firm Cardinal Health. The report ranks the top U.S. losses of exclusivity based on U.S. sales from the prior year.