AstraZeneca won some important breathing space after defending its cholesterol-lowering blockbuster Crestor from a patent challenge in the US.
The company said it has entered into a settlement agreement with Actavis and Egis Pharmaceuticals over their plan to launch generic Crestor (rosuvastatin calcium), blocking competition for the product until May 2016.
The verdict is a boost to AstraZeneca as it tries to re-energise the business under the direction of recently-appointed chief executive Pascal Soriot, who laid out his plans for the company in a strategic review last week.
Crestor needs to remain the engine for AstraZeneca for a few years yet, but has already started to be affected by generic competition to other big-selling cholesterol drugs, notably Pfizer’s Lipitor (atorvastatin), which lost US patent protection in 2011.
Last year, the product brought in $6.25bn for the pharma company – down around 4 per cent year-on-year – with around half ($3.16bn) of that total coming from the US alone.
As a condition of the settlement the generics companies have agreed not to appeal a decision handed down by a US appeals court last December that upheld the validity and enforceability of substance patent for Crestor.
Actavis (formerly Watson Pharma) filed for approval of generic versions of AstraZeneca’s product based on rosuvastatin calcium and rosuvastatin zinc and as a result of the settlement will now be able to sell its products on an exclusive basis in the US between May 2 and July 8, 2016.
The substance patent for Crestor expires on January 8, 2016, but AstraZeneca won a six-month extension under the US paediatric trials incentive programme. Sales of Actavis’ generic before the extension expires on July 8 will incur a 39 per cent royalty fee to AstraZeneca.
The victory in the US overshadows some bad news for AstraZeneca earlier this month when it lost a lawsuit defending Crestor’s intellectual property in Australia. The brand has also lost exclusivity in Brazil and Canada, where sales plunged 84 per cent last year as a result.