Benicar (Daiichi Sankyo)
Patent expiry: October 2016

2012 sales: $2.446 billion
2011 sales: $2.602 billion
Change: (6%)

A little questioning by the FDA over the safety of Daiichi Sankyo's Benicar has not kept the hypertension drug from retaining its blockbuster status. Though sales of Benicar dipped in 2012, it is among the leaders of angiotensin receptor blockers, or ARBs, a category that includes Novartis' ($NVS) Diovan.

Questions were raised in 2010 about the cancer risks of ARBs, but a follow-up study by the FDA the next year removed that taint. The FDA has also conducted safety reviews of Benicar specifically for increased heart death risk in patients with diabetes but asserted that Benicar's benefits outweigh any potential risks.

Benicar's patents are not set to expire until 2016, but the Japanese company is already feeling the heat from generic drugmakers. Mylan Pharmaceuticals ($MYL) has won the right to sell the drug exclusively for the first 180 days after the patent expires on the blockbuster.

Still, both companies may face competition sooner than they thought. In November 2012, Apotex petitioned a U.S. court to rule that its Benicar generic wouldn't infringe patent rights. A finding of noninfringement, Apotex said, would let it compete with Mylan sooner. But Apotex has yet to get its own drug approved by the FDA.

For more:
FDA: ARBs don't increase cancer risk


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