Fierce Pharma, an American news outlet specializing in pharmaceutical industry analysis and data, has published an extensive list of globally recognized medications set to lose their patent protection in 2025. This loss of exclusivity means these drugs will no longer be shielded from competition with generic alternatives starting this year.
As Fierce Pharma points out, patent expirations are a routine occurrence in the pharmaceutical world, but 2025 stands out for the unusually large number of drugs affected. Among the companies facing significant losses are industry giants such as Johnson & Johnson and Novartis.
Key Medications Losing Exclusivity in 2025
Stelara (Johnson & Johnson)
Stelara, a treatment for psoriasis, psoriatic arthritis, ulcerative colitis, and Crohn’s disease, is Johnson & Johnson’s most high-profile case. In 2024 alone, it generated $6.72 billion in U.S. sales. While the company previously warned of a “patent cliff” in 2023, it managed to extend its exclusivity—temporarily. Now, Stelara faces growing competition from biosimilars, with more expected to enter the market as its patent expires.
Simponi / Simponi Aria (Johnson & Johnson)
Also from Johnson & Johnson, Simponi is used for conditions like rheumatoid arthritis, ankylosing spondylitis, and ulcerative colitis. It brought in $1.08 billion in U.S. sales in 2024. While not facing as many competitors as Stelara, two biosimilars are currently in development, with planned launches by the end of 2025.
Prolia / Xgeva (Amgen)
These two Amgen drugs—sharing the active ingredient denosumab—are used to treat various bone-related conditions, including osteoporosis and bone complications in cancer patients. Together, they generated $4.39 billion in U.S. sales in 2024. Generic competition is already on the horizon, with Sandoz emerging as a key player.
Eylea (Regeneron)
Regeneron’s Eylea, prescribed for age-related macular degeneration and diabetic eye conditions, is another major drug losing exclusivity. Unlike other cases, Eylea has already seen declining sales since Roche’s Vabysmo entered the market in 2022.
Entresto (Novartis)
Entresto is a widely used treatment for heart failure. Although generic versions are already available, Novartis remains heavily invested in the drug, which generated $4.05 billion in U.S. sales in 2024.
Promacta (Novartis)
Used to treat aplastic anemia and thrombocytopenia, Promacta doesn’t reach Entresto’s sales levels, but its patent loss is still a blow for Novartis. It recorded $1.18 billion in U.S. sales in 2024.
Tasigna (Novartis)
Tasigna, used in the treatment of leukemia, is another Novartis drug losing exclusivity. Although 2024 saw a decline in revenue, the drug still brought in $848 million in the U.S.
Soliris (AstraZeneca)
Soliris, exclusive in the U.S. for nearly 20 years, treats rare conditions like paroxysmal nocturnal hemoglobinuria and generalized myasthenia gravis. AstraZeneca is positioning Ultomiris as its successor. Despite sales declines in Europe due to biosimilars, Soliris earned $1.52 billion in the U.S. in 2024.
Brilinta (AstraZeneca)
Brilinta, used for treating various cardiovascular conditions, has benefited from the rise in hospitalizations during the COVID-19 pandemic. Biosimilars could hit the U.S. market by mid-2025, just as Brilinta continues its upward sales trajectory.
Tysabri (Biogen)
Biogen’s Tysabri, prescribed for multiple sclerosis and Crohn’s disease, generated $920 million in U.S. sales in 2024. The drug is already facing pressure from its biosimilar Tyruko, which launched in 2023 and is expected to enter the U.S. market soon.
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