A federal judge late Tuesday refused to issue an order that would have blocked several companies from selling generic versions of the Crestor cholesterol pill in the US.
The decision is a blow to AstraZeneca (AZN), which last month filed a lawsuit against the US Food and Drug Administration in hopes of thwarting generic competition to its blockbuster drug, a $5 billion seller last year. The drug maker claimed the agency was about to illegally broaden the indication for the drug and, as a result, unfairly permit low-cost copycat versions of Crestor.
Now, several companies — including Sandoz, Mylan Laboratories, Apotex, Aurobindo, and Sun Pharma — are poised to sell generics. In reaching his decision, US District Court Judge Randolph Moss, who is based in Washington, D.C., rejected an argument from AstraZeneca that it was entitled to seven years of additional exclusivity to sell Crestor in the US market. The FDA, meanwhile, rejected a citizen’s petition filed by AstraZeneca seeking to halt generics.
An AstraZeneca spokeswoman wrote us that the company is disappointed with the ruling, but is “currently assessing” its options.
At issue was a controversial maneuver AstraZeneca used to try to maintain a monopoly on Crestor through 2023. The drug maker accused the FDA of illegally interpreting federal law governing product labeling and sought to prevent the agency from broadening the indication for Crestor. Patent protection for the drug expired earlier this month, which is why the company sought a temporary restraining order.
As we reported previously, AstraZeneca last May won FDA approval to sell Crestor to treat children with a genetic disorder called homozygous familial hypercholesterolemia or HoFH, which causes very high cholesterol. And thanks to the Orphan Drug Act, the company was awarded an extra seven years of marketing exclusivity, but only for treating this particular rare, or orphan, disease.
However, the drug maker maintained that any generic version must include all pediatric labeling information that was approved for Crestsor. And so, facing an expiring patent, AstraZeneca filed its lawsuit over concerns the FDA would, instead, rely on a decision made last year in which generics were allowed to exclude certain information in such situations, so long as a safety risk is not created.
That case involved Otsuka Pharmaceuticals, which tried to prevent generic versions of the Abilify antipsychotic. Essentially, AstraZeneca mimicked the Otsuka playbook, which involved filing a lawsuit claiming the FDA was illegally widening the market for the drug and unfairly opening the door to generic competition. Ultimately, Otsuka did not succeed and the FDA approved generic versions.
In its lawsuit, AstraZeneca insisted that the FDA’s interpretation of the law would pose a safety risk if applied to Crestor. The drug maker contended that any generic label could render generics potentially dangerous. The drug maker argued that a doctor may still prescribe a generic for HoFH, but choose an incorrect dosage since generic labeling would not contain the same information as Crestor.
The US Department of Justice, however, belittled that argument. “This case is not about the medical needs of a small population of pediatric patients with a rare disease,” the Justice Department wrote in court documents. “It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines.”
A delay in generic versions of Crestor may have placed patients at a disadvantage. A recent study in JAMA Internal Medicine found that a six-month delay in the availability of generic versions of the Lipitor cholesterol pill prevented consumers from benefiting from lower out-of-pocket payments.