What is Apotex’s ruxolitinib filing date in the US?
I can’t confirm Apotex’s US ruxolitinib filing date from the information provided here. The filing date depends on the exact US application route (for example, ANDA vs. an alternative pathway) and the specific product strength/formulation, and those details aren’t included in your prompt.
Where to verify the exact filing date (and what to look for)
To confirm the filing date reliably, you typically need to check a primary US source for the exact submission record tied to the ruxolitinib product, such as:
- FDA’s Orange Book entry for the specific ruxolitinib drug product (look for applicant/manufacturer and related submission details).
- The FDA ANDA/application database or related FDA records that show the “received” or “submission” date for the relevant application.
If you share the missing details, I can pin it down
If you paste one of the following, I can help you determine the correct filing date to confirm:
- The specific Apotex product listed (strength(s) and dosage form), or
- The FDA Orange Book “product name”/NDC for the Apotex ruxolitinib you mean, or
- A link or screenshot of the FDA/Orange Book entry you’re looking at.
Quick clarification that affects the “filing date”
Ruxolitinib could refer to different US products (and different formulations/strengths). Also, “filing date” sometimes gets used loosely to mean either the FDA submission received date or the date the applicant publicly listed it in litigation/Orange Book context. The exact source matters.
Sources
No sources were provided in your message, so I can’t cite any confirmation of Apotex’s US ruxolitinib filing date.