- A federal court on Tuesday blocked AstraZeneca's last-ditch attempt to prevent new generic copies of its top-selling cholesterol drug Crestor, Reuters reports.
- U.S. District Judge Randolph Moss denied AstraZeneca's request for a temporary restraining order blocking the entry of generics, clearing the way for new competitors to enter the market. Sales of Crestor, which totaled over $5 billion last year, are likely to fall.
- With the path to market now clear, several Indian drugmakers, including Aurobindo and Sun Pharma, said Wednesday they had received US approval for their respective Crestor generics.
While "disappointed" in the ruling, AstraZeneca said it was "assessing its options," according to a statement from a spokesperson.
Crestor had been due to go generic this year, but AstraZeneca attempted to extend its market exclusivity after the FDA approved a new use for the drug to treat children with a rare inherited form of high cholesterol.
The FDA had previously granted an orphan drug designation for that indication, which grants seven years of exclusivity—but only for that specific use. AstraZeneca, however, argued any generics approved for the drug's more typical use would thus carry incomplete product labels and should be blocked from the market.
A temporary injunction would have stopped new copies entering the market until the labeling question was decided. But Judge Moss ruled that AstraZeneca was not likely to prevail in a lawsuit on the issue, and refused to grant an injunction, Reuters said.
Generic drugmakers, including Par Pharmaceuticals, Apotex and Novartis' Sandoz unit, now have a clearer path to market. And Indian companies Aurobindo and Sun Pharma said Wednesday they already won approval for their copies.
New competitors will join Allergan's Crestor copy in the U.S., which has been on the market since May under a settlement deal reached with AstraZeneca in 2013.
AstraZeneca's CEO Pascal Soriot has termed patent expiry for Crestor a "transitional period" for the company, as it aims to grow top-line revenue to $45 billion by 2023. But if sales of brand-name Crestor erode quickly in the face of new generic competition, that goal will much harder to meet. Crestor sales accounted for about 20% of AstraZeneca's nearly $25 billion in revenue last year.