Based on the available information, there is no specific proposed filing date for Apotex's Ruxolitinib ANDA (Abbreviated New Drug Application). However, the process for filing an ANDA for a generic drug like Ruxolitinib involves several steps and regulatory agencies.
First, it's important to note that Ruxolitinib is a drug used to treat certain types of blood cancer and is marketed under the brand name Jakafi by Incyte Corporation. Incyte holds the patent for Ruxolitinib, which is set to expire in 2026 [1]. Once the patent expires, generic drug manufacturers like Apotex can file an ANDA with the U.S. Food and Drug Administration (FDA) to produce a generic version of the drug.
The FDA website provides information on the process for submitting an ANDA, including the required patent certifications and suitability petitions [2]. However, it does not provide specific information on the filing date for Apotex's Ruxolitinib ANDA.
Health Canada, the regulatory agency responsible for approving drugs in Canada, provides a list of generic submissions under review, but Ruxolitinib is not currently listed [3]. Therefore, it is unclear whether Apotex has already filed an ANDA for Ruxolitinib in Canada.
In summary, based on the available information, there is no proposed filing date for Apotex's Ruxolitinib ANDA. However, generic drug manufacturers like Apotex can file an ANDA with the FDA once the patent for Ruxolitinib expires in 2026.
Sources:
1. <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>
2. <https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions>
3. <https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html>