The drug: Xarelto (rivaroxaban)
The disease: Cardiovascular
The developers: Bayer and J&J
Peak projections: Bayer estimates around $2.87 billion

Xarelto has already snagged an approval for preventing blood clots after orthopedic surgery, but its pending application for approval to prevent strokes is where the blockbuster revenue can be found. Effective, safer replacements for warfarin are expected to earn $20 billion a year, and Xarelto's owners want a big slice of that.

The drugmakers won't have long to wait before regulators pass sentence on stroke prevention, but intriguingly Xarelto also recently posted promising data in the acute coronary syndrome crowd, something that Eliquis couldn't manage.

"As expectations for Xarelto in acute coronary syndrome were zero, this is a positive for Bayer," Bernstein Research said in a note at the end of September. "It at least opens the door to a potentially large and lucrative indication."

The irascible pharma critics at Public Citizen want regulators to stick with proven winners in the stroke-prevention field, urging the FDA to turn thumbs down on the treatment. Public Citizen has a much high safety bar than the agency, which may not have trouble ignoring them once again.

Boehringer Ingelheim already won an approval for Pradaxa, giving it the advantage of being the first to the marketplace. Pfizer and Bristol-Myers Squibb are in hot pursuit with Eliquis. Any slip here could cost billions.

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