There’s a huge scramble among generic drugmakers seeking to sell copycat versions of Pfizer’s Norvasc, the popular med for blood pressure and chest pain that rang up $2.5 billion in US sales last year. The ruckus was unleashed two week ago, after an unexpected federal court ruling made it possible for Mylan Labs to begin sales a few months earlier than expected.

By Wednesday, the FDA has promised a federal court that it will decide whether to approve still more copycats, although Mylan is trying to block that move so it can have another few months of exclusive marketing, other than Pfizer’s authorized generic. The decision hinges on various interpretations of patent law guiding the definition of exclusive marketing rights.

The case is quite complicated and is being closely watched due to the court’s interpretation of the Norvasc patent expiration, not to mention the FDA view of all this. Among the generics lining up are Teva, Apotex, Caraco, Watson and Roxanne. Each has written the FDA explaining why it should have the right to sell generic Norvasc right away, and others don’t.

Interestingly, Medco has also weighed in, arguing the FDA should allow everyone to sell copycats. “FDA should immediately (or as soon as permitted to by a court) grant final approval to all tentatively approved” applications to sell generic Norvasc, writes Dave Machlowitz, general counsel for the PBM, which aggressively pushes generic usage.

Everyone has a vested interest in the outcome, though. Beyond the intricacies of interpreting patent law and FDA law, the case illustrates why a little reform may be worth considering. Companies have the right to protect their assets and seek relief in court, but this approach is time-consuming and expensive.

The FDA docket containing letters from Medco and others;
Background reading in The Orange Book Blog.

Hat tip to The Orange Book Blog.

[tags]Medco, Mylan Laboratories, Norvasc, Pfizer, Teva Pharmaceuticals[/tags]