Lupin gets USFDA nod for generic cholesterol drug

The US health regulator has granted approval to Lupin to market generic Fenofibrate Tablets, a cholesterol lowering drug, in the American market.

According to information on the US Food and Drug Administration (USFDA) website, Lupin has got the approval to sell 48 mg and 145 mg of generic Fenofibrate tablets in the American market.

However, the company did not comment on the issue and the possible launch date of the product.

According to Morgan Stanley Research, Abbott, the innovator of the drug, had filed patent litigations against seven firms, out of which five including those against Lupin and Teva have been settled.

Abbott sells the drug under Tricor brand.

As per the report Lupin could launch its generic version as early as July next year.

"We have assumed December, 2012 (181st day) launch for Lupin, which may now potentially be earlier [July, 2012] in light of possible forfeiture of Teva's exclusivity. This would translate into earlier and greater upside for Lupin from this product in 2012," Morgan Stanley Research said in a report.

Teva, which had the exclusive marketing rights for the generic drug, had said its version of Tricor 145 mg ($1.2 billion brand sales) will not be approved by USFDA in 2012, the report said.

Under the provisions of its settlement with Abbott, Teva was expected to launch it in either March, 2011 or July, 2012 under certain circumstances.

"We have assumed this to be a $50 million annual sales opportunity for Lupin [starting December 2012], assuming 80% price erosion and 20% market share, which may turn out to be conservative," Morgan Stanley said.