How close is Teva Pharmaceuticals
As of the third quarter, Momenta Pharmaceuticals
But an application by Teva and another by Amphastar Pharmaceuticals and Watson Pharmaceuticals
That brings us back to the question of how close Teva is to launching a generic version of Lovenox. Teva announced today that the FDA has a "short list of questions, which Teva intends to respond to in the near future." Momenta's shareholders took that to mean an approval is coming sooner rather than later and sent the shares down 20% today.
Maybe that's prudent, although without knowing exactly what the questions are, I think it's a little hard to know how easily it will be for Teva to answer the questions. Keep in mind that Lovenox is a complicated molecule. Teva's application has been under review by the FDA since 2003, and the FDA took five years to review Momenta's application. Momenta's scientists are experts in heparin -- the base molecule of Lovenox -- having helped the FDA sort out Baxter's
Today's drop could be a good spot to buy the Motley Fool Rule Breakers recommendation if the launch of Teva's drug is delayed by the FDA or Momenta's patents. But those are two pretty big ifs, and shares won't reach their true potential until the billion-dollar question has a definitive answer.
Momenta made my list of Black Friday bargains. Here's the rest of the list.