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What is the status of the apotex ruxolitinib anda application?



The status of the Apotex Ruxolitinib ANDA application can be gleaned from the provided sources. DrugPatentWatch indicates that the patent for Ruxolitinib expired in 2027, which opens up the possibility for generic versions to enter the market. The FDA document suggests that Apotex filed an Abbreviated New Drug Application (ANDA) for Ruxolitinib, indicating their interest in producing a generic version of the drug. Additionally, Health Canada's webpage on generic submissions under review does not specifically mention Apotex or Ruxolitinib, but it is a platform where updates on generic drug applications are typically posted. Therefore, the current status of Apotex's Ruxolitinib ANDA application can be monitored through these regulatory channels for any developments or updates.

Sources:
[1] drugpatentwatch.com/p/tradename/RUXOLITINIB
[2] fda.gov/media/71502/download
[3] canada.ca/en/health-canada/services/drug-health-product-review-approval/generic-submissions-under-review.html



Follow-up:   Has the FDA approved the Apotex ruxolitinib ANDA application? Are there any updates on the Apotex ruxolitinib ANDA status? When can we expect a decision on the ruxolitinib ANDA?





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