How long should a drug company be allowed to be the exclusive manufacturer and seller of their product? Crestor, a best-selling statin (cholesterol-lowering drug) that has enjoyed exclusivity for the last 12 years, is due to lose that protection today. AstraZeneca, the maker of Crestor, is fighting that decision, hoping to squeeze a little more time as the drug’s exclusive manufacturer before generics hit the market.

There’s already a generic version for sale: the version by Watson Pharmaceuticals went on the market back in May, before AstraZeneca’s exclusivity expired, as part of a patent infringement settlement. The question is whether the Food and Drug Administration will approve multiple other generic versions of Crestor, which are ready to hit a pharmacy near you soon.

Even a slight delay is helpful. After all, the company took in $7 million in Crestor sales every day before Watson’s version hit the market. Two years ago, CEO Pascal Soriot promised to double the company’s revenue by 2023. Coincidentally, that’s when the company’s exclusive right to sell the drug in the United States would expire if its latest move works.

Here’s how they would be able to keep exclusivity for a total of nineteen years, keeping prices for patients and insurance companies high and blocking generics from the market when they’re ready to go. AstraZeneca was able to prove that Crestor is effective against homozygous
familial hypercholesterolemia, a relatively rare hereditary disease that causes very high cholesterol levels in children.

In theory, this would gain AstraZeneca the exclusive right to sell Crestor for use in children with this specific condition. However, the company argues that if generic Crestor is on the market, it would not include safety and prescribing information for doctors who treat children with homozygous
familial hypercholesterolemia. Doctors would just prescribe regular Crestor to them, and won’t someone think of the children?

Astra Faces Off With FDA on Copycats for $7 Million-a-Day Drug [Bloomberg]

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