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Lupin Ltd has received final approval from the US Food and Drug Administration (USFDA) to market its oral contraceptive Vyfemla tablets, the company said in a statement on Friday.
This is the generic version of Warner Chilcott Company LLC’s Ovcon 35 tablets. “Lupin’s US subsidiary Lupin Pharmaceuticals Inc shall commence marketing the product shortly,” the statement said.
Warner Chilcott’s Ovcon 35 tablets had annual US sales of about $22.3 million, Lupin said. The oral contraceptive market in the US is valued at around $5 billion and is growing at around eight per cent annually, according to Lupin.
“Moreover, a less competed for segment, the US oral contraceptives generics market is dominated by just a few players — TEVA, Watson and Sandoz,” said Lupin, which entered this segment in September 2011.
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