Cosentyx (secukinumab) was first approved in the United States in 2015. Its original “drug substance” patents—those that cover the active molecule and its basic use—were filed in the late 2000s and are set to expire around 2028 in the U.S. That is when Novartis’ core patents on the molecule will lapse and the drug will technically enter the public domain.
However, a few things can still keep it off‑patent a bit longer:
| What may keep it off‑patent | Typical duration |
|-----------------------------|-------------------|
| Formulation and delivery patents (the specific injection mix, preservative, device, etc.) | Often 10–12 years, may last a few years after the main patent |
| Method‑of‑use or new‑indication patents (e.g., treating ankylosing spondylitis) | 10–12 years, can extend exclusivity |
| Regulatory exclusivity (e.g., 5‑year FDA exclusivity for first biologic for psoriasis) | Already expired (last in 2020) |
| Data exclusivity (protecting clinical trial data) | 5‑year period for biologics, already passed |
Because of those additional layers, generics may still be blocked until the late 2020s or early 2030s, depending on how Novartis files secondary patents and how the FDA or other regulators interpret them.
International differences
- Europe: Most of the key patents expire in 2028–2030 as well, but some European patents (e.g., for the formulation) may last a couple of years longer.
- Canada: Patents are typically tied to the U.S. dates, so expiry is also around 2028.
- Australia: Similar pattern; primary patents expire 2028–2029.
Bottom line
If you’re looking at the core drug patent, Cosentyx’s U.S. patents will lapse in 2028. But the practical entry of biosimilars or generics may not happen until a few years later, once all secondary patents and exclusivity protections have run their course.