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news.Barr Pharmaceuticals has confirmed that its subsidiary, Barr Laboratories has initiated a challenge of the patents listed by AstraZeneca in connection with its Entocort enteric coated capsules, 3mg.
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The company believes that it is the first to file an abbreviated new drug application (ANDA) containing a paragraph IV certification for Entocort enteric coated (EC).
Barr filed its ANDA containing a paragraph IV certification for a generic Entocort EC product with the FDA in January 2008. 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 May 22, 2008, AstraZeneca filed suit in the US District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.