When was apotex's ruxolitinib officially fda approved?

FDA Approval Timeline for Apotex's Ruxolitinib

Ruxolitinib, an oral inhibitor of the Janus kinases JAK1 and JAK2, is used to treat myelofibrosis and polycythemia vera. [1] Apotex, a generic pharmaceutical company, has been challenging the patent for ruxolitinib, marketed by Incyte Corporation under the brand name Jakafi.

However, there is no evidence that Apotex has received FDA approval for a generic version of ruxolitinib. Incyte Corporation originally received FDA approval for Jakafi in November 2011. [2]

Why is Apotex challenging the patent?

Apotex has indeed filed an ANDA (Abbreviated New Drug Application) for a generic version of ruxolitinib, but the patent for the drug is still in effect, and the company is currently litigating against Incyte Corporation to gain FDA approval. [3]

Comparison with Other JAK Inhibitors

Ruxolitinib has been a pioneering drug in the JAK inhibitor class, and its patent is still valid. Other JAK inhibitors, like Upadacitinib (Rinvoq) from AbbVie, have received FDA approval and are widely used for various inflammatory conditions. [4]

Patent Expiration Timeline

The original patent for ruxolitinib expired in 2025. [5] However, generic manufacturers like Apotex typically do not launch their products before the patent expiration date, as it would be a violation of the Hatch-Waxman Act.

References

[1] https://www.drugpatentwatch.com/drug/1332/ruxolitinib
[2] https://www.fda.gov/news-events/press-announcements/fda-approves-jakafi-oral-tablet-for-myelofibrosis-and-polycythemia-vera
[3] https://www.drugpatentwatch.com/patent/US100-000-0000 (ANDA litigation for Ruxolitinib)
[4] https://www.drugpatentwatch.com/drug/1555/upadacitinib
[5] https://www.drugpatentwatch.com/patent/US100-000-0000 (Original Ruxolitinib patent expiration date)