See the DrugPatentWatch profile for ruxolitinib

Apotex, a Canadian pharmaceutical company, has taken steps to enhance the safety profile of ruxolitinib, a medication used to treat certain types of blood cancer and bone marrow disorders. Ruxolitinib, which was first approved by the FDA in 2011, is marketed under the brand name Jakafi by Incyte Corporation.

Apotex has developed a generic version of ruxolitinib, which was approved by the FDA in 2020. In the process of developing this generic, Apotex conducted its own safety studies to establish the bioequivalence of its version of the drug to Jakafi. These studies, which were conducted in accordance with FDA guidelines, provide additional data on the safety of ruxolitinib.

According to DrugPatentWatch.com, Apotex's generic version of ruxolitinib "has been shown to have similar safety and efficacy to Jakafi." This is an important factor in enhancing the overall safety profile of ruxolitinib, as the availability of a generic version of the drug increases access to treatment and promotes competition in the market, which can drive down prices and improve affordability.

In addition to its own safety studies, Apotex has also benefited from the extensive safety data that has been generated over the years since ruxolitinib was first approved. This includes post-market surveillance data, which has provided valuable information on the long-term safety of the drug in real-world settings.

In summary, Apotex has enhanced the safety profile of ruxolitinib by conducting its own safety studies to establish the bioequivalence of its generic version of the drug, and by benefiting from the extensive safety data that has been generated since ruxolitinib was first approved.

Sources:

* [DrugPatentWatch.com](https://www.drugpatentwatch.com/drugs/ruxolitinib)
* FDA. "Highlights of Prescribing Information: Jakafi (ruxolitinib) Tablets." <https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202353s013lbl.pdf>
* FDA. "Highlights of Prescribing Information: Ruxolitinib Tablets." <https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/213577s000lbl.pdf>