Generic drug company Synthon Pharmaceuticals has received tentative U.S. Food and Drug Administration approval on its application to make a version of UCB‘s (EBR:UCB) allergy medicine Xyzal.
Netherlands-based Synthon, which has its U.S. headquarters and laboratories in Research Triangle Park, North Carolina, said it is seeking to bring a generic version of Xyzal oral solution to the U.S. market with partner Perrigo (NASDAQ:PRGO). Michigan-based Perrigo is a maker of over-the-counter and generic pharmaceuticals.
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Synthon said it believes it is the first to file an application with the FDA for a Xyzal generic. Being first to file gives Synthon the advantage of 180 days of marketing exclusivity over other Xyzal generics.
The FDA approved Belgium-based UCB’s antihistamine Xyzal in 2007. The drug has been marketed in the United States by partner Sanofi-Aventis (NYSE:SNY). It has been available in Europe since 2001.
Zyrtec, another UCB allergy drug, and Xyzal combined to generate $755.2 million in global sales in 2006. But Zyrtec’s sales suffered upon entry of generics into the market. Now Xyzal appears to be facing the same fate. Xyzal generates about $15 million in annual sales, according to information and publishing firm Wolters Kluwer.