2028, date not disclosed
Opdivo expected to lose US exclusivity
Company guidance. BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise.
When does Opdivo go off patent?
In the US, biosimilars can launch from 2028. Opdivo is sold by Bristol Myers Squibb. BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise.
Opdivo's US exclusivity date is based on company guidance. The date comes from the company's own filings or guidance. Secondary patents, new formulations or litigation can still move it. 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 |
|---|---|---|
| US compound patent (BMS estimate of minimum exclusivity) | Nivolumab itself | 2028 |
| EU estimate | Nivolumab itself (Europe) | 2030 |
| Japan estimate | Nivolumab itself (Japan) | 2031 |
| FDA orphan exclusivity | One approved use | 13 April 2031 |
BMS estimates Opdivo's minimum US market exclusivity ends in 2028, on the nivolumab compound patent. Opdivo Qvantig, the under-the-skin version approved in December 2024, has the same 2028 estimate, which excludes any protection from patent applications still pending. Amgen's biosimilar is under FDA review, and BMS and Ono sued Amgen in September 2026.
Sources: BMS 10-K 2025 · FDA Purple Book
| Year | Worldwide | US | Growth |
|---|---|---|---|
| 2023 | $9.01B | – | – |
| 2024 | $9.30B | $5.35B | +3% |
| 2025 | $10.05B | $5.90B | +8% |
Opdivo alone; Opdivo Qvantig added $0.24B in 2025. Worldwide net sales as reported, with the US share. Source: BMS 10-K 2025
Filed with the FDA Amgen's biosimilar is under FDA review, with a decision expected by the end of 2026. BMS and Ono sued Amgen on 8 September 2026, asserting seven patents.
| Company (product) | Stage |
|---|---|
| Amgen (ABP 206) | Filed with the FDA. Under FDA review |
Checked October 2026. Sources: Goodwin: BMS and Ono sue Amgen · Fierce Pharma
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 →
| Scenario | 2025 US sales | Year 1 (about 2029) | Year 2 | Year 3 |
|---|---|---|---|---|
| Fastest past case | $5.90B | $2.01B34% | $0.63B11% | $0.25B4% |
| Median | $5.90B | $3.86B65% | $2.26B38% | $1.57B27% |
| Slowest past case | $5.90B | $5.52B93% | $4.47B76% | $3.75B64% |
An illustration, not a forecast: it applies the past-cliff benchmarks to Opdivo's 2025 US sales, held flat until copies arrive in 2028. Year 1 is the first full year with copies on sale.
Opdivo is 21% of Bristol Myers Squibb's 2025 revenue ($10.1B of $48.2B). With Pomalyst, Eliquis and Reblozyl, the drugs tracked here add up to 61% of Bristol Myers Squibb's revenue losing US exclusivity by 2031.
Bars show each company's tracked drugs as a share of its total 2025 revenue. Opdivo is highlighted.
Company guidance. BMS guides to US biosimilar entry from 2028. Subcutaneous Opdivo Qvantig may extend the franchise.