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Judge Denies Order to Keep Generic Crestor Competitors Off the Market


AstraZeneca is trying to invoke the Orphan Drug Act to protect its blockbuster, on the grounds it is approved to treat a rare pediatric condition.

Updates with report of FDA approval for generic competitor.

AstraZeneca won’t be able to keeps generic versions of Crestor off the market while it sues to shield its blockbuster cholesterol drug from competition, a federal judge has ruled. Almost immediately, a new competitor announced it had received FDA approval for a generic version of rosuvastatin calcium tablets.

US District Judge Randolph Moss ruled late Tuesday that the drug maker was not likely to win a lawsuit seeking another 7 years of protection for Crestor, and thus denied AstraZeneca’s request for a temporary restraining order. The ruling opens Crestor to broader competition, barring an appeal.

By midday Wednesday, Sun Pharma announced that once of its subsidiaries had received final approval from FDA for rosuvastatin calcium. John Rother of the Campaign for Sustainble Rx Pricing praised the news as a win for consumers.

“We are glad to see that the court rejected AstraZeneca’s effort to abuse the Orphan Drug Act and restrict generic competitors to Crestor,” Rother said in a statement. “Additional competition in the prescription drug market—including generic options—is crucial to lowering prescription drug prices and providing patients with more affordable choices.”

Crestor lost patent protection July 8, 2016, but AstraZeneca had pre-emptively sued FDA to block rivals. AztraZeneca sought to invoke the Orphan Drug Act to thwart generics, on the grounds that only Crestor had approval to treat a rare pediatric condition that elevates cholesterol. That move was loudly opposed by consumer advocates and members of Congress.

US Senator Bernie Sanders of Vermont wrote FDA a letter July 7, 2016, saying AstraZeneca was trying to use a “loophole” to protect its blockbuster at the expense of consumers.

Attorney Chad Landmon, on behalf of generic drug maker Par Pharmaceuticals, had argued in a filing that AstraZeneca’s actions flew in the face of a recent ruling involving Otsuka and its antipsychotic, Abilify. Last year, Otsuka sought to block competitors on the grounds that Abilify had been approved to treat a rare disease, but a different judge ruled against the drug maker.

“AstraZeneca now seeks extraordinary relief,” Landmon said, including an order to bar generic competitors until May 27, 2023, “despite the fact that another court has already endorsed FDA’s ability to permit a (generic) applicant to carve out pediatric labeling protected by orphan drug exclusivity under nearly identical facts.”

An AstraZeneca spokeswoman told Bloomberg that the company was “disappointed” and would evaluate its options.

Generics that reach the market will also compete with Allergan’s Watson Pharmaceuticals, which gained the right to sell its version through a settlement with AstraZeneca. That drug reached the market in early May. If other generic competitors reach the market, Crestor sales are expected to fall significantly from the $5 billion generated worldwide last year.

According to the American Heart Association, 98.9 million people over age 20 have elevated levels of total cholesterol.

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