Sacubitril/Valsartan

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.

Lawyers for the government gave the first substantive signal that the Trump administration will continue to defend Medicare drug price negotiations in court. In a Wednesday court brief , attorneys for HHS said that the Inflation Reduction Act allows Medicare to address an “extraordinary and unsustainable” increase in certain drug prices. Several drugmakers have filed lawsuits against the IRA, most of which have been rejected in federal district courts and are now on appeal. HHS asked the US Court of Appeals for the Third Circuit to uphold a lower court’s decision against Novartis. HHS reiterated some of the core arguments that the Biden administration successfully made last year, including that the negotiations process is voluntary and does not constitute a taking of property or a violation of free speech. “A manufacturer that disagrees with the program terms or with the price the government is willing to pay is under no legal obligation to participate in the program,” lawyers for HHS said in the brief. The next round of negotiations is set to kick off next month, but the Trump administration’s public stance on the program has been largely unclear. In a statement in January , CMS said it would consider “opportunities to bring greater transparency” to the process and take ideas from stakeholders. The administration hinted at its stance in a motion filed last week to exclude an expert declaration in a lawsuit brought by industry group PhRMA and other organizations. But Wednesday’s brief marks the first time HHS has laid out its full legal defense of drug price negotiations. Advocacy group Patients for Affordable Drugs said HHS’ brief is a good sign for patients, “as the first round of negotiations delivered significant price reductions on some of the nation’s most expensive drugs.” But the group also cautioned that the future of the Medicare negotiations remains uncertain and “political pressure from Big Pharma remains strong.” Novartis, which took part in the first round of negotiations for Entresto, told Endpoints News on Thursday that it “firmly believes the drug price-setting provisions in the IRA are unconstitutional.” In its Wednesday court brief, HHS reemphasized that drugmakers don’t have to participate in negotiations: Instead, they can pull out of Medicare and Medicaid altogether, offload the selected drugs to another manufacturer, or pay an excise tax. “Plaintiff’s satisfaction with these options has no bearing on its ability to reject the government’s offer in the first place,” the agency said. Drugmakers have said the alternatives leave them no choice but to participate in negotiations. Even so, the Trump administration could make changes to the way it negotiates, including how easy it goes during negotiations. “They could still be doing things in a more industry-friendly manner, even as they defend against the constitutional attacks on the program,” said Zachary Baron, director of Georgetown University’s Center for Health Policy and the Law. “We’ll still have to see when it comes to implementation guidance, other different types of decisions that they may make that may deviate from what the Biden administration did.” Companies have until Feb. 28 to decide if they are taking part in the next round of negotiations. For those who are participating, certain information is due to CMS on March 1, and negotiations would take place over the following months. Negotiated prices would take effect in 2027.