When does Cosentyx go off patent?
In the US, biosimilars can launch from 2029. Cosentyx is sold by Novartis. Key exclusivities expected to end around 2029.
Cosentyx's US exclusivity date is based on patent-expiry estimate. It is estimated from patent expiry rather than a fixed entry date, so it may move as patents are challenged or extended. It is a biologic, so copies are biosimilars. Biosimilars are harder to make and usually erode sales more gradually than generics.
| Patent or protection | Covers | Expiry |
|---|---|---|
| Novartis estimate of US exclusivity | Patent and regulatory exclusivity combined | 2029 |
| Novartis estimate of EU exclusivity | Patent and regulatory exclusivity combined | 2030 |
Novartis lists 2029 as the year it expects Cosentyx to lose US exclusivity and 2030 for the EU, and warns that biosimilars could arrive earlier. Cosentyx was also selected for Medicare price negotiation, with a negotiated price taking effect in 2028, a year before biosimilars are expected.
Sources: Novartis 20-F 2025
| Year | Worldwide | Growth |
|---|---|---|
| 2023 | $4.98B | – |
| 2024 | $6.14B | +23% |
| 2025 | $6.67B | +9% |
Worldwide net sales as reported. Source: Novartis 20-F 2025
In clinical trials Celltrion's biosimilar has been filed in the EU and Canada, though not yet in the US. Bio-Thera has finished Phase 3, with Dr. Reddy's as its commercial partner.
| Company (product) | Stage |
|---|---|
| Celltrion (CT-P55) | In clinical trials. Filed in Canada (Jun 2026) and the EU (Jul 2026) |
| Bio-Thera / Dr. Reddy's (BAT2306) | In clinical trials. Phase 3 complete |
Checked October 2026. Sources: Goodwin: CT-P55 EU filing · Pearce IP: Canada filing
Among past biologics facing biosimilars, US sales in the first full year after copies arrived were a median 65% of the last full year before (range 34% to 93%, 7 drugs), and 27% by the third year (9 drugs). Biosimilars usually take share more gradually than generics. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Cosentyx was selected for the Medicare Drug Price Negotiation Program. CMS must publish the negotiated prices for 2028 by 30 November 2026. That is 1 year before US biosimilars can launch, so Medicare revenue comes under pressure first. For the 25 drugs negotiated so far, Medicare prices came in 38% to 85% below list price. Those discounts are measured before the rebates drugmakers already pay and apply to Medicare only. See every negotiated Medicare price →
Cosentyx is 12% of Novartis's 2025 revenue ($6.7B of $54.5B). With Entresto, Xolair, Kisqali and Kesimpta, the drugs tracked here add up to 46% of Novartis's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Cosentyx is highlighted.
Deadline for CMS to publish the negotiated prices for the drugs selected for 2028. The prices take effect on 1 January 2028. Xeljanz will have none, because CMS found a generic on sale.
Prices are due from CMS by 30 November 2026.
Patent-expiry estimate. Key exclusivities expected to end around 2029.