Lupin has launched a generic version of Mirabegron extended-release tablets for overactive bladder in the US, following USFDA approval. The drug is a generic equivalent of Astellas Pharma's Myrbetriq and has an estimated annual US market of USD 1.6 billion.
New Delhi, Sep 4 (PTI) Pharma major Lupin Ltd on Wednesday said it has launched its generic version of Mirabegron extended-release tablets used in the treatment of overactive bladder, following approval from the US health regulator.
The approval granted by the US Food and Drug Administration (USFDA) is for Mirabegron extended-release tablets of strength 50 mg, Lupin said in a regulatory filing.
Mirabegron extended-release tablets, 50 mg, is a generic equivalent of Myrbetriq of Astellas Pharma Global Development.
The estimated annual sales of USD 1.6 billion in the US, Lupin said, citing IQVIA MAT July 2024 data.
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