Cephalon Gets Its Patent Extension

Last week, I suggested a hidden reason for Cephalon pursuing ADHD designation for its narcolepsy drug Provigil was to get its patent extended. Pediatric testing of a drug earns it an extra six months of patent protection whether it gets approved for kids or not.

Last week, you'll recall, an FDA advisory committee voted 12-1 not to approve Cephalon's drug for ADHD. The FDA hasn't decided that question yet. But today, the agency granted the company its six month extension.

Now generics won't be able to enter the market until April 2012.

Congress gave the drug industry these six-month extensions as an incentive to conduct pediatric trials on drugs that kids may need (like cancer drugs), but on whom there had never been any testing to determine dose or effectiveness. Now we're seeing more and more companies use this as a loophole to simply get longer exclusivity on their best-selling drugs. Is there no arm of the government willing to look into abuses of this provision? Clearly the FDA isn't up to the job.