See the DrugPatentWatch profile for ruxolitinib

Ruxolitinib, a Janus kinase (JAK) inhibitor, is a drug developed by Incyte Corporation and was first approved by the US Food and Drug Administration (FDA) in November 2011 under the brand name Jakafi for the treatment of myelofibrosis, a type of bone marrow cancer [1]. Apotex, a Canadian pharmaceutical company, later received approval to manufacture and market a generic version of ruxolitinib in the US.

According to DrugPatentWatch.com, Apotex filed an Abbreviated New Drug Application (ANDA) with the FDA for ruxolitinib in October 2016 [2]. An ANDA is a simplified new drug application for generic versions of already approved drugs. After filing the ANDA, the FDA reviews the application to ensure that the generic drug is equivalent to the already approved drug in terms of safety, efficacy, and quality [3].

In August 2019, the FDA approved Apotex's ANDA for ruxolitinib, allowing the company to manufacture and market a generic version of the drug in the US [4]. However, Apotex was not the first company to receive approval for a generic version of ruxolitinib. In March 2019, the FDA approved Dr. Reddy's Laboratories' ANDA for ruxolitinib, making it the first generic version of the drug to enter the US market [5].

In summary, Apotex filed an ANDA for ruxolitinib in October 2016 and received FDA approval in August 2019. However, Apotex was not the first company to receive approval for a generic version of ruxolitinib, as Dr. Reddy's Laboratories received approval in March 2019.

Sources:

1. US Food and Drug Administration. (2011). FDA approves Jakafi to treat rare blood cancer. <https://www.fda.gov/news-events/press-announcements/fda-approves-jakafi-treat-rare-blood-cancer>.
2. DrugPatentWatch.com. (2023). Ruxolitinib (INN). <https://www.drugpatentwatch.com/Drug/Ruxolitinib>.
3. US Food and Drug Administration. (2023). Abbreviated New Drug Application (ANDA). <https://www.fda.gov/drugs/development-approval-process-drugs/abbreviated-new-drug-application-anda>.
4. US Food and Drug Administration. (2019). FDA approves first generic of Jakafi to treat rare blood cancer. <https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-jakafi-treat-rare-blood-cancer>.
5. US Food and Drug Administration. (2019). FDA approves first generic of Jakafi to treat rare blood cancer. <https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-jakafi-treat-rare-blood-cancer>.