Generic player Synthon have filed ANDA with Paragraph IV certification against innovator Sepracor/UCB’s Orange Book listed patents on Levocetirizie Dihydrochloride (Xyzal) Oral Solution 2.5 mg/5ml. Following patent is listed in Orange Book for this product:
US5698558 (Expiry: September 24, 2012): This patent covers a method of treating the symptoms of seasonal and perennial allergic rhinitis in a human which comprises administering to a human in need of such symptomatic relief therapy an amount of (-) cetirizine, or a pharmaceutically acceptable salt thereof, substantially free of its (+) stereoisomer, said amount being sufficient to alleviate or palliate said allergic rhinitis.
After receipt of Para IV notice from Synthon on May 5, 2009, Belgian healthcare group UCB S.A. and Sepracor has filed a legal action on 17 June, 2009 against generic player Synthon for allegedly infringing ‘558 patent on its antihistamine drug levocetirizine (Xyzal) in the District court for the Eastern District of North Carolina .
Possibly, Synthon is first Para IV filer for this product. Also, Perrigo pharma will be the marketing partner of Synthon for this product.
Levocetirizie dihydrochloride (Xyzal) Oral Solution 2.5 mg/5ml was approved by USFDA on Jan 28, 2008. Also, this product has got new product exclusivity which will expire on May 25, 2010.
Further, innovator has already sued various generic players like Synthon, Sun Pharmaceuticals, Sandoz and Barr, who have filed ANDA for Levocetirizie dihydrochloride (Xyzal) 5mg tablets.
Perrigo Press release Here
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