We all know that Dacogen is slated to go off patent in November of 2013. The way I understand it, if it is approved for AML, Dacogen could get an additional 6 months of exclusivity. Still, as we all know, it won't be very long before Dacogen gets competition from generic manufacturers.
My question, however is, are any companies working on a generic version?
If I remember, Dacogen was approved on an orphan drug status, and as a result, there is not a huge market for the drug. Adding AML to the list of approved indications might expand the market, but is it enough of an expansion to justify generics makers to try to develop an equivalent?
deb Eisai does not need to 'develop' a generic version of Dacogen. All they have to do is change the NDC number on the package and sell it at a generic price and its a generic. They could get a generic marketing partner if they dont want to do it themselves
However since this drug has subtantial brand sales I am quite sure there will be multiple generic approvals from other companies and the price is likely to drop at least 80% from what the brand is now and since the market share will be split among multiple companies any roylaties will be negiligble.
Watch what happens to Vidaza when the patent expires that will be a good modeling tool.
Thanks Batzem. The market is currently 600M or so, with dacogen having near $240M in sales, so if there's an 80% drop in selling price, that's only $48M market in generic for dacogen. That's sound pretty thin to have multiple companies vying for a piece of it. I'm sure dacogen is not cheap to make, so will the cost to manufacture, maybe keep most generics away from this small market?
Eisai has a generic division and has also partnered several drugs nearing generic versions. So what's to say that they take the next step and develope a generic version of dacogen? Supg receives royalities for 20 years all indications.