Barr confirms Entocort patent challenge

1 June 2008

US generics firm Barr Laboratories has initiated a challenge of the patents listed by Anglo-Swedish drug major AstraZeneca in connection with its Entocort (budesonide) enteric coated capsules, 3mg. The US company believes that it is the first to file an Abbreviated New Drug Application containing a Paragraph IV certification for Entocort EC.

Barr filed its ANDA with the Food & Drug Administration in January 2008. Following receipt of the notice from the agency that the firm's ANDA had been accepted for filing, Barr says it has notified the New Drug Application and patent holder of its move.

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