Pharma Major Lupin Limited (Lupin) announced that it received tentative approval from the United States Food and Drug Administration (FDA) for selling Silodosin capsules, a generic version of Allergan Sales’ Rapaflo capsules.
Silodosin capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia, or the enlargement of tissue due to high rate of cellular reproduction.
Rapaflo had US sales of USD 228.7 million. The drug helps relax the muscles in the prostate and bladder neck, making it easier to urinate.
Tentative approval indicates that the original branded product has one or more patents that are yet to expire. Sales of tentatively approved products can only start after the patents on the branded products expire.
Lupin’s silodosin capsules are the AB rated generic equivalent of Allergan Sales, LLC’s Rapaflo Capsules and can be substituted by the pharmacist. AB-rated drugs are drugs that meet the necessary bio- equivalence standards established by the Food and Drug Administration (FDA).
Lupin manufactures a wide range of branded & generic formulations, biotechnology products and APIs globally.
For the financial year ended 31st March, 2016, Lupin’s Consolidated sales and Net profit stood at Rs 136,539 million ($ 2.09 billion) and Rs 22,607 million ($ 345 million) respectively.