In a blow to Mumbai-headquartered Lupin, global pharma company Mylan has launched Fenofibrate capsules to tackle coronary heart disease in the US. The capsules are the generic equivalent to Lupin's anti-cholesterol drug Antara, one of its key US brands.
It is estimated that the drug contributed $43 million to Lupin’s FY12 topline. Being a branded drug, the product contributed around 40 per cent to PAT margin.
After acquiring the brand in 2009, Lupin sold the abbreviated new drug application (ANDA) on Antara to Dr Reddy’s, which was the first to file. Other filers include Apotex, Ranbaxy and Paddock. The substance patent on Antara is set to expire in 2020.
The United States Food and Drug Administration (FDA) granted final approval to Mylan's generic version of Antara on January 10. Lupin had tried to delay the launch through an appeal in the Federal Court that granted an injunction over the district court ruling.
Analysts said Mylan has launched the product at risk.
“Given the generic launch of the product, we estimate a loss of $18-20 million, which is 1 per cent of FY14 sales and 2 per cent of FY14 PBT for Lupin,'' said Manoj Garg of Edelweiss Securities.