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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Generic versions of AstraZeneca’s blockbuster Crestor will hit the US market after a federal judge refused to issue a restraining order blocking the approval of rosuvastatin ANDAs.
A federal judge has officially denied AstraZeneca’s bid for seven more years of patent exclusivity by way of orphan drug legislation for its blockbuster drug Crestor (rosuvastatin). According to July 19, 2016 decision, the court refused to issue a restraining order that would prevent generic versions of Crestor for coming to market, Reuters said in a report.
In late May, Crestor received an Orphan Drug designation for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), providing the blockbuster drug exclusivity for this indication until 2023. Crestor, which is also approved to treat non-pediatric patients with high cholesterol, lost its patent protection for this indication in July 2016. In court documents, AstraZeneca asked the court to prevent generic versions of the drug from coming to the market. According to Reuters, US District Judge Randolph Moss, ruled that the company “was not likely to win a lawsuit claiming it should get seven more years of exclusive rights to the drug thanks to its recent approval to treat a rare pediatric illness.”
AstraZeneca also submitted a Citizen Petition to FDA, requesting the agency include data from its HoFH trial on the Crestor label and to refrain from approving Abbreviated New Drug Applications (ANDAs) referencing Crestor and its HoFH indication on or before May 27, 2023. In a July 19 letter, FDA denied the company’s petition noting, "orphan drug exclusivity is limited in scope and protects against approval only of the same drug for the same indication. It does not preclude approval of the same drug for which orphan drug exclusivity was granted for a different, non-protected indication."
FDA also says it will allow for an omission on generic labels if the indication is protected by patent exclusivity. The agency wrote in a letter, “Congress explicitly acknowledged that ‘the bill permits an ANDA to be approved for less than all of the indications for which the listed drug has been approved.'” This means, labels for generic versions of Crestor can be approved without the indication for HoFH.
Other pharmaceutical companies have already announced plans to release generics versions of rosuvastatin. FDA approved the first generic version of the drug in late April, before the AstraZeneca received the Orphan Drug designation for the HoFH indication. Indian pharma company Aurobindo announced on July 20, that it has received approval from FDA for a generic version of Crestor. Sandoz, Mylan, and Apotex have also released generic versions of the drug.
According to Reuters, Crestor accounted for more than 20% of AstraZeneca’s sales in 2015, which topped off at approximately $23.6 billion. A spokesperson for the company told Reuters that overall, they are “disappointed” with the decision.