Claiming "Orphan" Status, AstraZeneca Sues FDA to Protect Crestor Patent

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The lawsuit seeks an additional 7 years' protection for the popular cholesterol drug, which sold 20.3 million prescriptions last year.

To a layperson, it might seem odd to hear that a drug with more than 20 million yearly prescriptions would seek “orphan” status. But that’s what happening with Crestor, the popular cholesterol-fighting therapy that in May won FDA approval to treat children with a rare condition, homozygous familial hypercholesterolemia (HoFH).

What seems easier to grasp is that AstraZeneca, the maker of Crestor (rosuvastatin calcium), would take FDA to court to gain an additional 7 years’ of protection for its blockbuster, which is scheduled to go off patent July 8, 2016. AstraZeneca’s May approval gives it exclusive rights to market Crestor for pediatric HoFH, but the drugmaker believes that under the Orphan Drug Act, FDA should block all generics of Crestor from the market.

The maker of Abilify, Otsuka Pharmaceuticals, tried a similar tact last year, but lost after going to court.


HoFH affects only a few hundred children in the United States. Adults with high cholesterol number in the tens of millions—sales of Crestor netted $2.8 billion last year.

The threat from competitors is apparent. According to Fierce Pharma, sales of a generic offered May 1, 2016, by Watson Pharmaceuticals, under a patent settlement with AstraZeneca, quickly reached 150,000 scripts, compared with Crestor’s 200,000.

News of AstraZeneca’s move, first reported in The New York Times, brought an outcry from the Campaign for Sustainable Rx Pricing.

“Abusing rules and regulations to keep competitors out of the market is common in the prescription drug industry, but AstraZeneca’s latest undertaking is especially egregious,” said CSRxP Executive Director John Rother. “AstraZeneca is trying to maintain (its) monopoly and keep more than 20 million patients from accessing a lower-cost cholesterol medication. It’s morally wrong, punishes patients and their families, and keeps prices high for everyone.”

The move comes as Americans are increasingly frustrated by the high cost of prescription drugs—polling by CSRxP, the Kaiser Family Foundation, and others show that frustration with high costs is the one healthcare issue that unites Democrats, Republicans, and independents.

Today, an analysis by Bloomberg found that 30 out of the 39 top-selling drugs in the world had price increase more than double the rate of inflation. Rother said the report shows “drug companies are using a broken market to keep prices high … the whole scheme is unsustainable.”