UCB SA (Belgian drug maker) and its US partner Sepracor sued Sun pharmaceuticals for Xyzal. They have filed second law suit in two months to stop the generic entry of Xyzal.
The law suit was filed on wednesday on US district court for the Eastern District of North Carolina. UCB alleged that Sun pharmaceuticals Industries ltd. infringed the company's patent for levocetirizine hydrochloride 5mg by filing an ANDA with USFDA.
xyzal tablet 5mg was approved by USFDA in May 2007. There is only one patent (US5698558) listed for this product in the orange book for this product. The 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."
As per my opinion this claim is difficult to design around so Sun might be having invalidation strategy against this patent.
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