The Rs 3,900 crore Lupin has moved the Food & Dr­ug Administration (FDA) of the US to ward off new competition to its Suprax sales in that country.

It has asked FDA not to approve any applica­tion for cefixime (the gen­eric na­me of Suprax) in or­al sus­pension unless it me­ets the same standards that the Lupin drug had to me­et.

Among its potential co­mpetitors are Orchid of Chennai, which has made a filing, and the Delhi-ba­sed Nectar Lifesciences, which plans to.

The petition was filed on October 22. Sup­rax saw gross sales of $74 million (Rs 350 cr­ore) in 2008-09, Lupin told investors in a May presentation.

Lupin got the licence for the drug from Fujisawa in 2003-04 and came up with many variants to ra­ise entry-barriers for ot­hers. But Suprax is a product on which the patent has alre­ady expired and any company can make and market it.

Orchid has already filed an application relating to cefixime in the US and expects its product to kick in next year. Nectar too has similar plans.

“Lupin had to meet very stringent requirements to get the FDA approval and wants to ensure that all ot­her applicants meet the­se same requirements,” a co­mpany spokesperson told Financial Chronicle.

If similar drugs from other companies have easy access to the market, it will impact Lupin’s sales of Suprax in the US.

“If competitors (like Orchid) launch the product, Lupin is expected to protect its turf,” pharmaceutical analyst Manoj Garg of the brokerage, Emkay Global Financial Services, said.

Around 8 per cent of Lupin's 2009-10 sales are expected to come from Suprax, Ravi Agarwal, a pharmaceutical analyst at Edelweiss, said in an October 26 note.