The Hindu Business Line : Glenmark in patent challenge over cholesterol drug

Mumbai March 28 After Zocor and Lipitor, another blockbuster cholesterol drug, Ezetimibe, has come under a patent challenge. Schering Corporation and MSP Singapore Company LLC have filed a suit in the US against Glenmark Pharmaceuticals in an effort to block the Indian drug company from proceeding with the commercialisation of its version of Ezetimibe.

Ezetimibe is marketed by Schering under the brandname Zetia and the cholesterol drug is a blockbuster, grossing $1.5 billion in the US.

"We believe that for us, it is the first time that we would be the only one and this would entitle us to have a 180-day exclusivity on sales in the US and not a shared exclusivity," Glenmark Pharmaceutical's Managing Director and Chief Executive Officer, Mr Glenn Saldhana, told Business Line on the prospects of Glenmark's version of Ezetimibe, if the US court ruled in its favour.

Schering Corporation and MSP Singapore Company filed the suit in the US District Court for the District of New Jersey. Glenmark is the first and believes the only, applicant to have filed an ANDA (abbreviated new drug application) for Ezetimibe with a paragraph IV certification on October 25, 2006, the company told the Bombay Stock Exchange. The patent on Zetia expires in October 2016.

The aggressive Para IV strategy involving a patent challenge has been a strategy adopted by big Indian drugmakers such as Ranbaxy and Dr Reddy's, with varying degrees of success. So, when mid-sized company Glenmark tossed its hat into the patent-challenge ring, it evoked cautious interest among analysts. Though a favourable decision in a Para IV challenge brings in more revenues when the exclusivity kicks-in, the downside is that the strategy bores a hole in the company's kitty because of the litigation involved. This sentiment was reflected in Glenmark's stock price that fell by 4.64 per cent, to close at Rs 592.35 on the BSE.

"Our strategy is not to go after Para IV. Of the 15 or 20 products in our pipeline, maximum two or three may be patent challenges," Mr Saldhana said, attempting to soothe ruffled sentiment. Glenmark has a similar patent challenge on desloratidine, he said.

Schering's Zetia is reportedly the fourth most-prescribed cholesterol drug globally, after Pfizer's Lipitor, Merck's Zocor and Bristol Myers Squibb's Pravachol. Pfizer is locked in a patent battle with Ranbaxy over the $12-billion Lipitor, Merck's $4.5 billion, Zocor has seen similar generic onslaught from Israeli company Teva and Ranbaxy.

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