The Crestor generics are coming. AstraZeneca failed its last-ditch attempt to protect the blockbuster brand Tuesday, when a federal judge denied its bid for a restraining order.
AstraZeneca had argued that a brand-new orphan drug approval should protect the $5 billion statin drug till 2026. It petitioned the FDA last month, contending that the agency’s own policies would bar generic drug labels that did not include data on the new pediatric indication. Because of orphan drug exclusivity, that data was AstraZeneca’s exclusive province.
When the agency didn’t act on its petition, AstraZeneca sued. After a flurry of last-minute argument Tuesday, Judge Randolph Moss decided the company’s argument didn’t fly, according to the federal court docket in the case. The FDA's generic approvals are now official.
It was a bold, if questionable, attempt to shield a multibillion-dollar drug from generic competition. Otsuka had failed in a similar bid last year, when it sued to block Abilify copycats; the company’s atypical antipsychotic is also approved for an orphan drug use.
Now, with a half-dozen generics makers revved up to launch their products, AstraZeneca’s massive brand stands at the nether edge of its patent cliff. Actavis was already selling an authorized generic, under a patent settlement with AstraZeneca, but the biggest danger to branded meds comes after multiple copycats hit the market.
Indeed, the blockbuster statin med had remained one of the company’s top sellers, despite that authorized generic. Evercore ISI analyst Umer Raffat recently charted brand and generic Crestor script numbers since the copycat launched May 1, and the trend lines show the generic quickly gaining market share--and Crestor losing it--but those changes leveled off early this month, with Crestor’s brand scripts at just over 200,000 and the generic’s at just over 150,000.
Now, if Crestor follows the usual patent-cliff trajectory, the brand will quickly tank, leaving AstraZeneca billions of dollars in the hole.
For the generics makers, the stakes were high, too. Knockoff versions of mass-market blockbusters like Crestor are their bread and butter, with sales and earnings estimates often depending on big launches like this. Sun Pharma, Par Pharmaceutical, Aurobindo Pharma, Apotex, Mylan and Glenmark Pharma had all joined the AstraZeneca lawsuit to fight for their Crestor copycat approvals, and several had said they were ready to ship their products immediately.
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