Merck wins patent fight over Zetia, Vytorin

Merck successfully fended off the generics company Mylan in a court battle over its cholesterol-lowering drugs ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin).

The U.S. Court of Appeals for the Federal Circuit in Washington upheld Merck’s patent on Feb. 7 in response to Mylan’s appeal of a previous ruling in 2012. The court agreed that the patent was valid and enforceable until its expiration in April 2017.  

Merck is one of several pharmaceutical companies trying to keep generic manufacturers at bay. In December 2012, a federal court ruled that a substance patent for rosuvastatin calcium, the active ingredient in AstraZeneca’s Crestor, is valid and enforceable.

Together, sales for Zetia and Vytorin brought in more than $1 billion in the fourth quarter of 2012, according to Whitehouse Station, N.J.-based Merck. Worldwide sales for Zetia were $676 million in the fourth quarter of 2012, up from $640 in the same quarter of the previous year. Yearly sales totaled $2.6 billion, up from $2.4 billion in fiscal year 2011. Vytorin’s fourth quarter sales were $435 million, down from $475 million in the fourth quarter of 2011. Yearly sales dropped from $1.9 billion in fiscal year 2011 to $1.7 billion in fiscal year 2012.

Generics are expected to take a bite out of some cholesterol-lowering drug sales in the coming years, according to GBI Research. By 2018, the valuation of the worldwide market for statins is expected to fall from $19.7 billion in 2012 to $12.2 billion and generics’ market share is projected to increase from 11 percent in 2011 to 34 percent. For slides from the analysis, please click here.