See the DrugPatentWatch profile for ruxolitinib

Based on the available information, there is no clear indication of the current status of Apotex's Ruxolitinib approval by the FDA. However, it can be inferred that there have been legal proceedings involving Ruxolitinib and its approval.

According to the first source, a patent for Ruxolitinib, a drug used to treat certain types of blood cancer and bone marrow disorders, was issued in 2011 and is set to expire in 2030 [1]. The second source, a page on the FDA's website, lists approvals and notifications for oncology and hematologic malignancies, but Ruxolitinib is not mentioned [2].

The third source, a court opinion from the United States Court of Appeals for the Federal Circuit, provides more context. The case, "In re: Roxane Laboratories, Inc.," involves Roxane Laboratories, a subsidiary of Apotex, and the patent holder, Incyte Corporation [3]. The court opinion states that Roxane had filed an application with the FDA for approval to manufacture and sell a generic version of Ruxolitinib, but the FDA had not yet made a decision [3].

In summary, based on the available information, it appears that there have been legal proceedings involving Ruxolitinib and its approval, but there is no clear indication of the current status of Apotex's Ruxolitinib approval by the FDA.

Sources:

* <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>
* <https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications>
* <https://cafc.uscourts.gov/opinions-orders/19-2011.OPINION.8-22-2023_2178325.pdf>