Chennai, Aug 20
Pharmaceutical major Lupin Ltd
on Thursday said it has got the USFDA approval for anti-cholesterol
tablet though a sector analyst said the drug may not contribute to the
company's financials majorly.
Lupin, in a statement, said it has
received final approval from the United States Food and Drugs
Administration (USFDA) to market a generic version of Teva's Fenofibrate
Tablets, 54 mg and 160 mg, which have US sales of $156 million.
"Lupin's US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US," the company said.
According
to Lupin, its Fenofibrate tablets 54 mg and 160 mg are the AB rated
generic equivalent of the current reference listed drug, Fenofibrate
Tablets 54 mg and 160 mg of Teva.
"It is indicated as an adjunct
to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase
HDL-C in adult patients with primary hypercholesterolemia or mixed
dyslipidemia and for treatment of adult patients with severe
hypertriglyceridemia," the statement said.
On Thursday the Lupin stock opened at BSE opened at Rs.1,820 as against previous close of Rs.1,795.45.
The stock price touched a high of Rs.1,939.90 and later changed hands at around Rs.1,892.
However
Angel Broking's vice president research, pharma, Sarabjit Kour Nangra
is of the view that the drug may not contribute to Lupin's financials in
a major way.
Nangra said the drug is mainly used to reduce cholesterol levels in patients at risk of cardiovascular disease.
"Like
other fibrates, it reduces low-density lipoprotein (LDL) and very low
density lipoprotein (VLDL) levels, as well as increasing high-density
lipoprotein (HDL) levels and reducing triglyceride levels," she said.
According
to her, though the drug is highly competitive and hence unlikely to
contribute significantly to the company, its getting approval is
positive as the approval has come from Lupin's Goa plant, which
underwent USFDA audit.
On the other hand Lupin said it has close to 20 percent market share of the overall US Fenofibrate market.
The
company is the 6th largest and fastest growing top five generics player
in the US, it said, adding it now has 81 products in the market and is
the market leader in 31 products marketed in the US generics market.
The company is amongst the top three by market share in 55 products.
Cumulative
ANDA (abbreviated new drug application) filings with the US FDA stood
at 215, as on June 30, 2015 with the company having received 120
approvals to date. The company has 35 First-to-Files (FTF) products
which includes 15 exclusive FTF opportunities
