June 2028
First Jakafi composition patent expires
The second expires in December 2028. Incyte has settled with five of nine challengers on confidential terms.
When does Jakafi go off patent?
In the US, generics can launch from 2028. Jakafi is sold by Incyte. Incyte 10-K: estimated minimum US market exclusivity 2028, when the composition patents expire. Jakafi is 60% of Incyte's revenue.
Jakafi'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 small-molecule drug, so copies are generics. Generic launches usually take most of the US volume within months.
| Patent or protection | Covers | Expiry |
|---|---|---|
| US 8,722,693 | Ruxolitinib itself, with pediatric exclusivity | 12 December 2028 |
| US 7,598,257 and 8,415,362 | Compound, salt and drug product, with pediatric exclusivity | 24 June 2028 |
| Europe and Japan | Minimum market exclusivity, per Incyte | 2028 |
Incyte's patents on ruxolitinib and its salt expire in mid and late 2028 including extensions, and Incyte expects at least that long in the US, Europe and Japan. Nine companies have challenged the US patents; Incyte has settled with five on confidential terms and the other cases are pending. Granules has also filed to copy Jakafi XR, the extended-release tablet launched in 2026. Jakafi is about 60% of Incyte's revenue; Novartis sells it outside the US as Jakavi.
Sources: FDA Orange Book data files · Incyte 10-K 2025
| Year | Incyte (US only) | Growth |
|---|---|---|
| 2021 | $2.13B | – |
| 2022 | $2.41B | +13% |
| 2023 | $2.59B | +8% |
| 2024 | $2.79B | +8% |
| 2025 | $3.09B | +11% |
Novartis sells ruxolitinib outside the US as Jakavi and pays Incyte royalties. Net sales as reported. Sources: Incyte 10-K 2025 · Incyte 10-K 2023
Filed with the FDA Nine companies have challenged Jakafi's patents, which expire in June and December 2028. Incyte has settled with five on confidential terms; the other cases are pending.
| Company (product) | Stage |
|---|---|
| Hikma | Filed with the FDA; settled, terms confidential |
| Granules | Filed with the FDA; settled, terms confidential |
| Dr. Reddy's | Filed with the FDA; settled, terms confidential |
| Eugia | Filed with the FDA; settled, terms confidential |
| Alkem | Filed with the FDA; settled, terms confidential |
| Apotex | Filed with the FDA; in litigation |
| Sun Pharma | Filed with the FDA; in litigation |
| Alembic | Filed with the FDA; in litigation |
| MSN | Filed with the FDA; in litigation |
| Granules | Jakafi XR tablets: filed with the FDA Oct 2026. Patent challenge (Paragraph IV) |
Checked October 2026. Sources: Incyte 10-K 2025 · Incyte 10-Q, Q2 2026 · Medical Dialogues: Granules XR filing
Among past small-molecule drugs facing unrestricted generics, US sales in the first full year after copies arrived were a median 18% of the last full year before (range 0% to 48%, 10 drugs), and 6% by the third year (8 drugs). Where settlements limit generic volumes, as with Revlimid, the decline is slower. Every drug is different: settlements, how many copies launch, and pricing all change the curve. See the erosion benchmarks →
Jakafi is 60% of Incyte's 2025 revenue ($3.1B of $5.1B).
Bars show each company's tracked drugs as a share of its total 2025 revenue. Jakafi is highlighted.
The second expires in December 2028. Incyte has settled with five of nine challengers on confidential terms.
Incyte puts its minimum US market exclusivity at 2028.