AstraZeneca claims longer patent life in US for Crestor (rosuvastatin) to treat dyslipidaemia.
AstraZeneca has filed a citizen petition with the FDA arguing that the FDA cannot approve more generics because it granted Crestor (rosuvastatin) a new indication in late May 2016. This new indication would likely come with a pediatric orphan drug exclusivity until May 2023. The petition lays out legal reasons why the FDA cannot create that exclusive indication and approve generics for the rest of Crestor�s use. Should the FDA agree, AstraZeneca and Watson Pharmaceuticals, (subsidiary of Allergan) could continue to dominate the market.
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