Crestor patent row settled by Astra

AstraZeneca has seen off a remaining threat to its top-selling cholesterol drug Crestor by settling a US legal case with generic firms Watson Laboratories, a unit of Actavis, and Egis.

The settlement follows a US appeal court ruling in December involving other firms upholding the patent on the medicine, which AstraZeneca is relying on as sales of other products tumble.

AstraZeneca said yesterday that Watson and Egis had both conceded the Crestor substance patent was valid under the latest deal. The two companies had been trying to skirt round the patent by developing an alternative chemical version of Crestor.

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The agreement allows Watson to begin selling a generic form of Crestor on May 2, 2016, at a fee to AstraZeneca of 39 per cent of net sales, until the end of paediatric exclusivity on the drug on July 8, 2016. Egis, Watson’s partner, will also benefit from sales of the product.

The entry date may be earlier, and the fee eliminated, under certain circumstances, details of which were not given.

Crestor had worldwide sales of £4.10bn in 2012, making it AstraZeneca’s biggest seller, and £2.07bn of that was generated in the United States. AstraZeneca said the deal with Watson and Egis would now be filed with the US Federal Trade Commission and the Department of Justice.

Such agreements, under which big drug companies settle patent litigation with generic rivals by making deals to keep cheaper products off the market, are commonplace in the drugs industry but they are gaining greater scrutiny from governments.