Dr Reddy’s, on June 22, said that it had launched a generic version of Vascepa in the US. Vascepa is used in treating patients with high triglyceride levels.
The launch came a day after the US Supreme Court rejected a bid by the Amarin Corporation to revive six patents of Vascape. In 2020, the Federal Circuit court ruled in favour of Dr Reddy's and another generic drug-maker Hikma Pharmaceuticals that had challenged Amarin's patent claims over the drug.
Amarin six patents on Vascepa were set to expire in 2030.
Vascepa use in the US has been rising, with sales of $598 million in 2020. US-based Amarin Corporation markets the drug in the US.
Dr. Reddy’s generic Vascepa or Icosapent Ethyl Capsules, 1 gram was approved by USFDA in August 2020, as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe hypertriglyceridemia. However, the company could not launch the drug due to patent litigation and certain alleged anti-competitive practices like restricting access to supplies of active pharmaceutical ingredients.
Hikma went ahead and launched the drug at risk in November 2020.
Dr Reddy's said its generic Vascepa was not indicated for other cardiovascular risk conditions like myocardial infarction, stroke, coronary revascularisation, and unstable angina, limiting the scope of its sales.
Amarin earlier said that Hikma's drug threatened about $40 million in Vascepa's annual sales at 2020 prescription levels, given that the drug is only approved for narrow indications.
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