See the DrugPatentWatch profile for ruxolitinib

The approval of ruxolitinib by the US Food and Drug Administration (FDA) under the brand name Jakafi, manufactured by Incyte Corporation, has been a significant development in the treatment of certain blood disorders. However, the entry of a generic version of the drug into the market could potentially change access to ruxolitinib for patients in the United States.

Recently, Apotex, a Canadian-based pharmaceutical company, received tentative approval from the FDA for its generic version of ruxolitinib [1]. Tentative approval means that the FDA has determined that the Apotex product can be approved, but it cannot yet be commercially marketed in the US due to existing patents or exclusivities [2].

Once the patents and exclusivities protecting Jakafi expire, Apotex will be able to launch its generic version of ruxolitinib in the US market. This could lead to increased competition, which may result in a decrease in the price of ruxolitinib [3]. Lower drug prices can potentially improve access to the medication for patients, as it may become more affordable for both patients and insurance providers.

It is important to note that the exact timing and impact of Apotex's generic ruxolitinib on the US market will depend on the remaining patent landscape and any legal challenges that may arise [4]. Patients and healthcare providers should continue to monitor the situation and consult with their pharmacists and healthcare professionals for the most up-to-date information on ruxolitinib access and costs.

Sources:

1. DrugPatentWatch.com. (n.d.). Ruxolitinib (Jakafi) - Patent Expiration & Generic Entry. Retrieved from <https://www.drugpatentwatch.com/patent/ruxolitinib-jakafi-patent-expiration-generic-entry/>
2. U.S. Food and Drug Administration. (2021, October 1). Tentative Approval. Retrieved from <https://www.fda.gov/industry/process-generic-drugs/tentative-approval>
3. Harvard Health Publishing. (2019, August 14). The high cost of prescription drugs: Why they're so expensive and what you can do about it. Retrieved from <https://www.health.harvard.edu/diseases-and-conditions/the-high-cost-of-prescription-drugs-why-theyre-so-expensive-and-what-you-can-do-about-it>
4. U.S. Food and Drug Administration. (2021, October 1). Generic Drugs: Questions and Answers. Retrieved from <https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers>