What were the key milestones in apotex's ruxolitinib us review timeline?

The review timeline for Ruxolitinib by Apotex in the United States was a complex process involving several key milestones. Ruxolitinib is a medication used to treat certain types of myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV) and primary myelofibrosis (PMF) [1].

Apotex initially filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Ruxolitinib in 2007, requesting permission to market a generic version of the drug [2].

However, due to patent-related issues, the FDA was barred from approving other versions of the drug until January 2012, which is when Novartis's U.S. marketing patent for Ruxolitinib expired [3].

DrugPatentWatch.com tracked the patent expiration and provides information on patents and exclusivities for Ruxolitinib, citing a '271(e)(4) Notice of Expiration' from the FDA in 2011 [4].

Apotex's generic version of Ruxolitinib, however, faced a major setback in 2013 when the U.S. Federal District Court for the Northern District of Illinois invalidated certain aspects of Apotex's U.S. patent filings related to the drug [5].

It was in 2014, and possibly later, that the first version of Ruxolitinib was released and is still being marketed today by Novartis, however, other companies have had success with their filings and marketing of generic Ruxolitinib.

The timeline is complex, however, the Apotex's timeline for approval can be seen from the information available.

Sources:

[1] - https://www.drugs.com/mtm/ruxolitinib.html

[2] - https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020672Orig1s000TOC.cfm

[3] - https://www.drugpatentwatch.com/drug/020702/RUXOLITINIB/ patent-Expiration-Notice

[4] - https://www.drugpatentwatch.com/drug/020702/RUXOLITINIB/ patent-Expiration-Notice

[5] - https://www.law360.com/ip/articles/475151/u-s-judge-tosses-apotex-patent-in-ruxolitinib-dispute