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.

advertisement

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.

Leave a Comment

Please enter your name.
Please enter a comment.

  • Sorry, Karen, but in fact it really doesn’t matter HOW generics are CREATED. They can have dog poo as an ingredient as long as they are PHARMACEUTICALLY EQUIVALENT with respect to the rate and extent of absorption of the active moiety. For small molecules the only exception are Narrow Therapeutic index drugs, where even very small differences in blood levels can tip the margin of safety or efficacy. I’m in the Pharma business and so I don’t blame you. We have spent a fortune over the years trying to convince people that generic drugs are “inferior” to brand name drugs, kind of like the “tastes great, less filling” argument. I need to take generics, not for the above reason but I need to save up $6000/year for my psoriasis drug that has no generic and won’t have for 23 more years thanks to the creativity of my industry’s $500/hour patent lawyers.

  • What’s with the hostility? If you prefer Brand, keep using it. No need to promote one over the other. As a physician for 30 years, I have learned to respect patients wishes when it comes to brand vs generic. It’s all about the cost.

    • More out of pocket costs for the consumer with “Brand” version. And not all generics are created the same.

  • Thank you for educating me on the process of pill making. I won’t wish on you he side effects of various pills. I’m pretty sure you can’t prescribe meds either

  • As an FNP I am aware of compounding and that Lipitor made me unable to walk. I am glad patients will e able o pay less, but there is a difference in med compounding & patient tolerance. I pay $30/month for Crestor-great insurance

    • You obviously are ignorant of the pharmaceutical manufacturing process. All of the eight approved generics for Crestor are made by standard manufacturing tablet presses. None are made by compounding, which I agree is witchcraft. All show equivalent blood levels to Crestor. Please continue to pay your $30 for Crestor. In my state I couldn’t even get the brand name Crestor now that generics are approved without a medical review, a quite frankly, a few Lipitor induced aches and pains won’t get you insurance approval for brand name Crestor. You should pick up a book and learn the definition of process manufacturing and pharmacy compounding.

  • Crestor is the only statin I can tolerate. 12 years post-CVA-will keep taking brand name

    • As a nurse educator you should know there is no difference between brand and generics except for a small group of drugs which Crestor doesn’t fall into. Even AZ doesn’t claim superiority but if you want to flush $256 down the pot every month than nurse jobs must be paying well or the AZ rep bought you a couple of slices.

    • Sorry for my lack of cross cultural competency. I call out people’s ignorance irrespective of race, creed, color or LGBTQI status.

  • The court should also add about $450,000,000 in damages to the 11 generic companies whose sales were delayed for 2 days based on annual Crestor sales.

A roundup of STAT’s top stories of the day in science and medicine

Privacy Policy