AstraZeneca sues Barr over Entocort patent

WILMINGTON, Del. Barr Laboratories is facing a patent infringement lawsuit after filing an application to make a generic version of AstraZeneca’s Entocort enteric-coated capsules, a treatment for inflammatory bowel diseases.

In a complaint filed in the U.S. District Court for the District of Delaware, AstraZeneca says it received a letter in early April stating that Barr had filed an application for a generic version of Entocort in January with a Paragraph IV certification on the product’s ’340 and ’602 patents. Neither patent has expired and both enjoy pediatric exclusivity—the ’340 patent until May 15, 2011, and the ’602 patent until Jan. 1, 2015.

AstraZeneca has requested that the approval of Barr’s application not occur before expiration of the period of exclusivity to which the patents are entitled, according to court documents.

Entocort EC had annual U.S. sales of approximately $125 million for the 12-month period ending in March, according to Barr.