Drug: Pradaxa
Company: Boehringer Ingelheim
PDUFA date: By about October 19
Market potential: Estimates start at $1.3 billion a year

Boehringer Ingelheim won't have long to wait for the FDA's final decision on this blood thinner, which should be just days away. But Pradaxa's blockbuster status is likely to be significantly influenced by a debate over dosing.

Pradaxa earned a unanimous endorsement from the FDA panel. But FDA staffers have been pushing for an approval on the higher, 150 mg dose while dissing the 110 mg dose. That may seem like a small affair compared to an approval versus nonapproval, but Pradaxa faces some big-time competition in Xarelto (J&J) and apixaban (BMS, Pfizer) as the cream of next-generation successors to the standard warfarin.

The winners in this race will be struggling to land a chunk of a market that will swell to anywhere from $10 billion to $20 billion in the next decade, making this one of the top drugs to watch as it plows ahead in its market. There's a high chance of success here, but Boehringer won't be truly happy with half of a loaf. Competitors are angling to prove that they can do the best job, and the stakes couldn't be bigger.