Teva, Actavis, Apotex, AstraZeneca, Novartis inflammation news

The U.S. District Court for the District of New Jersey ruled that U.S. Patent No. 7,524,834 covering AstraZeneca’s asthma drug Pulmicort Respules budesonide is invalid. The patent was set to expire in 2018, with pediatric exclusivity extending into 2019. AZ said it is reviewing its options, including an appeal. Following the ruling, Actavis launched its generic versions of 0.25 and 0.5 mg vials of Pulmicort Respules in the U.S.

The district court heard the case on remand. In October 2013, the U.S. Court of Appeals upheld an April 2013 ruling from the district court that AZ’s U.S. Patent No. 6,598,603 covering Pulmicort Respules is invalid, but reversed and remanded the district court’s ruling that the generic defendants do not infringe the ‘834 patent. Apotex, Actavis and Novartis’ Sandoz unit have all received FDA approval of their generic versions (see BioCentury, Nov. 11, 2013). ...