Lupin has received approval from USFDA for its ANDA, Mirabegron extended-release tablets, 25 mg and 50 mg (generic of Myrbetriq of Astellas Pharma). The product will be manufactured at Lupin’s facility in Nagpur and had estimated annual sales of US$2403 million in the US (IQVIA MAT June 2022).
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The drug is indicated for over active bladder and presents an interesting opportunity in the US amid limited competition. Lupin also has a few complex generics products like, gAlbuterol, gBrovana, gSpiriva and gSuprep, of which Spiriva is expected to be launched over the remainder of FY23. Amid efforts of restructuring the US business, such launches will benefit margins recovery from the US.
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