Taro files ANDA to challenge S-P's Claritin

Taro Pharmaceuticals has filed an Abbreviated New Drug Application withthe US Food and Drug Administration for Loratadine Syrup, as a nasal and non-nasal treatment for seasonal allergies, allergic rhinitis, and chronic idiopathic urticaria in patients aged six years and older.

Loratadine Syrup is a generic equivalent of Schering-Plough's non-sedating Claritin (loratadine) Syrup, the estimated US market for which is approximately $57 million a year, according to a Taro press release. Taro has submitted its application with a certification stating that it does not believe that its Loratadine Syrup infringes S-P's listed patents on Claritin Syrup. Although Taro has not received any legal documents with respect to this matter, the company has acknowledged that S-P has filed a patent infringement lawsuit that may prevent the application from being approved.