Drug Store News - Schering-Plough files Clarinex NDA
Schering-Plough, maker of the blockbuster antihistamine Claritin (loratadine) has filed a new drug application with the Food and Drug Administration to broaden the indication of its new drug Clarinex 5mg (desloratadine). Schering says Clarinex, positioned as a successor to the manufacturer’s blockbuster Claritin, currently treats seasonal rhinitis. Schering wants to expand its indication to perennial rhinitis.
Claritin, which comes off patent in 2002, boasted close to $3 billion in sales worldwide last year.
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Sepracor, which describes itself as “a specialty pharmaceutical company that develops and commercializes potentially improved versions of widely prescribed drugs,” or improved chemical entities (ICE), will share Clarinex royalties with Schering. “We developed the Clarinex metabolite, desloratadine, then sold Schering the patent,” explained Jonae Barnes, vice president of investor relations for Sepracor.
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