See the DrugPatentWatch profile for ruxolitinib

Based on the available information, there is no specific filing date for Apotex's Ruxolitinib ANDA (Abbreviated New Drug Application) provided. However, the process and resources for filing an ANDA can be outlined using the provided sources.

The FDA's drug approval process for generic drugs involves the submission of an ANDA, which must include information demonstrating that the generic drug is bioequivalent to the approved reference listed drug (RLD) [${2}]. Apotex, a leading generic pharmaceutical company, would follow this process for Ruxolitinib, a drug used to treat certain types of blood cancer and bone marrow disorders [${1}].

To begin the process, Apotex would need to submit an ANDA to the FDA, including data and information that demonstrates the generic drug's safety, efficacy, and bioequivalence to the RLD [${2}]. Once submitted, the FDA reviews the ANDA, which can take up to 10 months under the Generic Drug User Fee Amendments (GDUFA) [${2}].

As for the Canadian regulatory process, Health Canada's role is to ensure that the generic drug meets the appropriate standards for quality, safety, and efficacy [${3}]. The Canadian regulatory process for generic drugs is guided by the Food and Drug Regulations, which set out the requirements for the approval of new drugs, including generic drugs [${3}].

In summary, while the filing date for Apotex's Ruxolitinib ANDA is not provided in the available information, the process for filing an ANDA and the relevant regulatory agencies and requirements have been outlined.

Sources:

* [1] DrugPatentWatch. (n.d.). RUXOLITINIB. Retrieved from <https://www.drugpatentwatch.com/p/tradename/RUXOLITINIB>
* [2] U.S. Food and Drug Administration. (n.d.). Patent Certifications and Suitability Petitions. Retrieved from <https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions>
* [3] Health Canada. (n.d.). Generic Submissions Under Review. Retrieved from <https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html>