Taro Pharmaceutical Industries (Nasdaq: TARO)
announced Friday that it had filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for Loratadine Syrup, a generic equivalent of Schering Corporation's Claritin Syrup.
Loratadine Syrup is an allergy medication used in the treatment of seasonal allergies, allergic rhinitis, and for the treatment of chronic idiopathic urticaria in patients aged 6 years and older. The estimated annual market for Loratadine Syrup in the US is $57 million.
At this stage, Taro is in the ANDA application process and is not currently marketing Loratadine Syrup.
Taro submitted its ANDA to the FDA with a certification stating the company's belief that its Loratadine Syrup did not infringe Schering's listed patents on Claritin Syrup.
Although Taro has not been served with any legal documents with respect to this matter, Taro acknowledged news reports stating that Schering has initiated court action to prevent Taro's application from being approved.
According to these reports, Schering Corporation, an affiliate of Schering Plough, filed a patent infringement lawsuit against Taro to prevent the approval of Taro's ANDA for Loratadine Syrup. Once Taro's ANDA for Loratadine Syrup was accepted by the FDA, Taro notified Schering that it was challenging the patents protecting Schering's Claritin Syrup from generic competition.
The company fully expected Schering to file a lawsuit. The filing of such lawsuits had become a routine way in which branded manufacturers seek to extend their patents and marketing exclusivity for their products, Taro said. Taro said the lawsuit was without merit and that it intended, when served, to defend its position vigorously.
Taro Pharmaceutical Industries develops, manufactures and markets over the counter and prescription pharmaceuticals primarily in the Unites States, Canada and Israel, offering topical corticosteroids and antifungal cream products. Its shares fell 7.05% on Friday to $38.90 on the Nasdaq Exchange.
Published by Israel's Business Arena on 5 August, 2001