The Indian firm has a 180-day exclusivity for the product
Lupin is to launch a generic version of Valeant Pharmaceuticals’ diabetes drug Glumetza.
The Indian company has a 180-day exclusivity for the product, which had sales of US$450m in the US. The firm said it had launched 10 products in the US and received approvals for 21 products.
Lupin secured the right to sell the generic version of Glumetza following a settlement with Santarus in 2012, which then owned the drug. In 2013, Santarus sold the diabetes drug to Salix Pharmaceuticals. In 2015, Salix was acquired by Valeant Pharmaceuticals.
Generic Fortamet and Glumetza, which also treat diabetes, are set to ensure a huge upside for Lupin. The market opportunity for Fortamet and Glumetza (both Metformin XR product) has increased significantly, cushioning the impact of delays in approvals and launches.
In the recent past, Lupin has failed to receive timely approvals and launch of certain high value products in the US.
Other generic approvals and launches expected over the next 12 months include Renvela (with a market size of $1.6bn) and Welchol tablets (with a market size of $650m).