Jakafi’s generics: Possible delay in the entry?

[Manouche]

 »The patent expiration in mid-2028 might be the most significant obstacle to JAKAFI’s supremacy in the polycythemia vera treatment market. To address this, Incyte introduced the LIMBER (Leadership in MPNs and GVHD BEyond Ruxolitinib) life-cycle management initiative, which was meant to explore different monotherapy and combination methods to enhance and expand therapies for patients with MPNs and GVHD. The initiative currently focuses on developing a novel once-daily ruxolitinib formulation; ruxolitinib-based combinations with new targets such as PI3K, BET, and ALK2; and new treatment alternatives such as mutant CALR. If this LIMBER initiative receives a green signal, the company may be able to prolong its patent, delaying the arrival of generics into the market.In the long term, it will be fascinating to observe how JAKAFI is prescribed after BESREMi enters the polycythemia vera treatment market, or maybe rusfertide, which might be a contender if approved »

delveinsight.com/blog/besre...

[Manouche]

 »…DelveInsight estimates that rusfertide is expected to be launched by late 2024 in the US polycythemia vera treatment market. With BESREMI’s patent set to expire in 2034, rusfertide will have an edge in catering to the market share if no other potential emerging therapy enters the polycythemia vera treatment market... »

[EPguy]

It's strange that pharma can extend patents for an old product, this does seem common. In my field (mechanical) patents are set and cannot be extended unless there is an actual improvement. Extended release Rux would be an improvement, but it seems they will try to extend the patent on the old Rux we're using right now via a separate improvement it won't include.

The article suggests Rusfertide is equivalent to Bes or Rux. But I'm not aware of Rusf having any allele effect. By 2024 and later, this effect likely will be a top goal in the clinic, it already is for us. My guess is Rusf will be good for the PV pts who need only RBC control and don't seek allele reductions, and more likely, an adjunct for HU, IFN, Rux when HCT needs extra control.