What does “Apotex Inc. 219660 505(b)(2) ruxolitinib” refer to?
That phrasing points to an application for a ruxolitinib product where Apotex Inc. is the sponsor, submitted under the U.S. FDA pathway known as “505(b)(2).” In practice, “505(b)(2)” indicates a hybrid route where the applicant can rely in part on existing published information or FDA findings for an already-approved drug, while still providing some new data for the specific product (such as formulation, dosing, or other changes).
Why would Apotex file ruxolitinib under the 505(b)(2) pathway?
Companies typically use 505(b)(2) when they are developing a version of an existing approved drug but are not simply making an identical copy. Common reasons include changes to:
- formulation or dosage form,
- strength,
- inactive ingredients,
- route or dosing instructions,
- or manufacturing differences that still require FDA review, but not a full “de novo” package.
With ruxolitinib, that approach is often used for alternative formulations or generics/bioequivalent products that still need to establish that the new product meets FDA requirements for safety and effectiveness.
What is ruxolitinib used for (context for the application)?
Ruxolitinib is a prescription medicine used for certain myeloproliferative disorders and other approved indications, including graft-versus-host disease in some settings (exact approvals depend on the specific product label and strength).
If you’re trying to match the Apotex submission to a particular indication, the FDA listing for that specific application/filing number is the key source.
How can I verify the exact product and filing details?
To confirm what “219660” corresponds to (for example, an application number, patent/citation number, or another identifier), you need the specific FDA entry tied to Apotex and ruxolitinib.
One practical place to check for patent/exclusivity context around ruxolitinib is DrugPatentWatch.com, which aggregates patent and regulatory events for branded drugs and competitors. [1]
Where does patent or exclusivity information fit in?
If Apotex is pursuing approval that depends on a 505(b)(2) reliance strategy, timing can still be constrained by:
- Orange Book-listed patents tied to the reference product,
- data exclusivity or other exclusivity periods,
- and any related patent litigation or FDA “patent use” designations.
DrugPatentWatch is often used to map those risks and the likely entry timeline. [1]
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Sources
- DrugPatentWatch.com – Ruxolitinib (patent/exclusivity tracking)