Axinn Defeats TRO, Enabling Immediate Launch of Generic Versions of AstraZeneca’s Blockbuster Crestor

A team of attorneys from Axinn intervened on behalf of Par Pharmaceutical, Inc. and Apotex Corp. in the U.S. District Court for the District of Columbia to oppose AstraZeneca’s motion for a temporary restraining order. Attorneys from several firms intervened on behalf of five other generic pharmaceutical companies as well. AstraZeneca sought the order to block the FDA from approving generic versions of its top-selling cholesterol drug, Crestor (the fifth largest blockbuster drug on the market). AstraZeneca argued that the FDA cannot approve any generic versions of Crestor because it has so-called orphan drug exclusivity for a rare pediatric use of the drug that would prevent generic competition before 2023.

On July 19, U.S. District Judge Randolph Moss held a TRO hearing at which the Axinn team argued on behalf of all of the Intervenor-Defendants.  Judge Moss denied AstraZeneca’s motion for a TRO, allowing generic versions of the drug to enter the market. 

Last year, Axinn attorneys also defeated a TRO enabling the immediate launch of generic versions of Otsuka's blockbuster Abilify.