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news.Barr Pharmaceuticals has confirmed that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Tap Pharmaceuticals in connection with its Prevacid SoluTab delayed-release orally disintegrating tablets, 15mg and 30mg.
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Barr filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Prevacid SoluTab product with the FDA in November 2007. Following receipt of the notice from the FDA that Barr’s ANDA had been accepted for filing, Barr notified the new drug application and patent holder.
On June 9, 2008, Ethypharm, Takeda Pharmaceutical and TAP Pharmaceuticals filed suits in the US District Court of Delaware to prevent Barr from proceeding with the commercialization of its product.