Drug approved, but not being launched!

Cephalon: Provigil & Nuvigil

Cephalon markets Provigil [Modafinil - racemate drug]. Provigil is patent protected till 2012. It has been working on the isomer forms of the racemate. It finally went ahead with filing a New Drug Application for the R-isomer - R-modafinil, under the brand name - Nuvigil. This R-isomer is patent protected till 2023.

Cephalon received the approval for this R-isomer this week, BUT it says that it does not intend to market it for another THREE years. The WSJ blog gives this statement from Cepaholn's representative:
“We want to wait to more fully understand its full potential,” Cephalon spokeswoman Jenifer Antonacci told the Health Blog this afternoon. The drug was approved today to improve wakefulness in people with narcolepsy or whose regular slumber has been disturbed by shift work or sleep apnea. Cephalon says it’s studying other uses of the drug, including treating bipolar disorder.

Since the racemate is protected till 2012, I think that a launch in 2010 will be used to move people from the racemate to R-isomer in the two year period and a complete shift post 2012. So, though a 3 year delay today may sound surprising, to me, this makes a lot more sense. I am sure that the launch delay will not be a very good news to generic companies that are already trying to work on the generic R-isomer, even before its launch.