Amarin suffers defeat over Vascepa patents
A US judge has opened the door to generic versions of heart disease drug Vascepa (icosapent ethyl), after invalidating Amarin’s key patents covering the drug.
On Monday, March 30, District Judge Miranda Du of the US District Court for the District of Nevada found six patents covering Vascepa—which are all due to expire in 2030—to be invalid.
The decision has cleared the way for generic drugmakers Hikma Pharmaceuticals and Dr Reddy’s Laboratories, which have both filed Abbreviated New Drug Applications (ANDA) for Vascepa generics.
Vascepa, a synthetic version of fish oil that’s used to lower triglyceride levels, was approved by the US Food and Drug Administration (FDA) last year as an adjunctive (secondary) therapy to maximally tolerated statin therapy to reduce cardiovascular risk.
In her ruling, Du concluded that while the ANDA’s did infringe the patents, the patents were obvious in light of prior art.
John Thero, president and CEO of Amarin, said: “Amarin strongly disagrees with the ruling and will vigorously pursue all available remedies, including an appeal of the court’s decision and a preliminary injunction pending appeal to, if an ANDA is approved by FDA, prevent launch of generic versions of Vascepa in the US.”
The ruling is a blow for Amarin as sales of the drug accounted for almost all of Amarin’s $429.8 million in revenue last year. However, Thero added that he did not believe that there was an impending generic launch by the litigants at this time.
Hikma said that it was currently evaluating its options for launching its generic product following FDA approval, including an at-risk launch in the event the district court’s decision is appealed.
“We are very pleased with the district court’s decision, which demonstrates our continued ability to successfully litigate to bring greater value to our customers and patients in the US,” said Brian Hoffmann, president of Generics at Hikma.
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