Ruxolitinib patent expiration date?

What is the current status of the ruxolitinib patent?

Ruxolitinib is a medication used to treat certain blood disorders, including myelofibrosis and polycythemia vera. It is marketed as Jakafi in the United States by Incyte Corporation [1]. According to DrugPatentWatch.com [2], ruxolitinib was patented in the United States in 2011, and its patent expiration date differs by country.

How long does ruxolitinib's exclusivity last?

The patent for ruxolitinib is set to expire in 2026, but Incyte Corporation has established extended protection through regulatory exclusivities. In 2020, the FDA extended the market exclusivity for ruxolitinib in the treatment of polycythemia vera through 2030, and in 2022, it was extended through 2035 for the treatment of myelofibrosis [3].

Will generic versions of ruxolitinib be available before the patent expires?

The United States Food and Drug Administration (FDA) approved the first biosimilar of ruxolitinib, called Ivascya, in October 2022 [4]. This approval may allow generic versions of ruxolitinib to enter the market before the patent expires.

When will ruxolitinib's patent expire worldwide?

The patent expiration dates vary by country. For instance, in Japan, the patent for ruxolitinib expired in 2023.

Sources:

[1] Incyte Corporation. (n.d.). Jakafi (Ruxolitinib). Retrieved from https://www.incyte.com/patients/jakafi

[2] DrugPatentWatch.com. (n.d.). Ruxolitinib Patent. Retrieved from https://www.druggaon.com/patent/US20110028561

[3] FDA. (2020). Jakafi (Ruxolitinib). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204037s021lbl.pdf

[4] FDA. (2022). Ivascya (Ruxolitinib). Retrieved from https://www.fda.gov/drugs/biosimilars/fast-track-approvals/jakafi-ruxolitinib