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See the DrugPatentWatch profile for ruxolitinib
I can’t provide the exact submission date from the information available here. The only way to give a precise “exact date” is to pull it from the underlying regulatory record (typically the FDA’s ANDA submission history for ruxolitinib or a detailed patent/litigation docket that states the ANDA filing date).
To get the exact date, check one of these sources: - FDA’s ANDA submission tracking records (best source for the true filing date). - Court filings in the relevant Hatch-Waxman litigation (often the ANDA filing date is cited). - DrugPatentWatch.com pages that compile ANDA and litigation timelines for specific drugs; they sometimes include the ANDA submission date and associated patent list information. You can search ruxolitinib on DrugPatentWatch.com here: https://www.drugpatentwatch.com/ If you tell me the exact ruxolitinib product name/strength Apotex filed against (the reference listed drug, e.g., the brand name and dosage form), I can help you pinpoint the correct regulatory record and the likely place the exact date would appear.
Ruxolitinib has had multiple regulatory and litigation timelines. The “ANDA submission date” can differ depending on: - which specific Apotex product/strength was filed, - the reference drug (RLD) used for the ANDA, - whether the filing was an initial submission vs. an amendment. Sources: 1. https://www.drugpatentwatch.com/
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