CLARINEX MAKER SUES OVER GENERICS

Pharmacy Times, Volume 0, 0

A bid by a generic company in Largo,Fla, to produce a generic version of theallergy medication Clarinex (desloratadine)has been blocked by a lawsuitfrom Schering-Plough Corp, makers ofthe brand drug. The pharmaceuticalcompany has sued GeoPharma Inc andits subsidiary, Belcher Pharmaceuticals,in federal court in New Jersey forpatent infringement. The suit is tied toBelcher's filing for a generic version ofClarinex 5-mg tablets with the FDA.

Schering's lawsuit also names 12other pharmaceutical companies thatfiled for rights to generic Clarinex atthe same time as Belcher. Sales ofClarinex in 2005 reached $325 million,and, although competition was expectedto be tight, Mihir Taneja, chief executiveof GeoPharma, was surprisedthat so many others were lining up tomake generic Clarinex as well. He andthe other defendants are claiming thattheir versions of the allergy drug arebioequivalent to the brand version butdo not infringe on Schering's patent,which expires in June 2007. The FDAcan approve the generic filings ifthe complaint is not resolved in 30months.