Glenmark gets USFDA nod to market generic malaria drug

Glenmark Pharmaceuticals today said it has received US health regulator's approval to market atovaquone amd proguanil hydrochloride tablets, used in treating malaria, in the American market.

Glenmark Generics, the US subsidiary of the company has received final approval for its abbreviated new drug application (ANDA) from US Food and Drug Administration for atovaquone and proguanil hydrochloride tablets, Glenmark said in a filing to the Bombay Stock Exchange (BSE).

Atovaquone amd proguanil hydrochloride tablets, which are generic versions of GlaxoSmithKline (GSK's) Malarone tablets, will be marketed in strengths of 250mg and 100 mg.

In April 2010, the company had confirmed the settlement of litigation with GSK over patent actions concerning atovaquone amd proguanil hydrochloride tablets.

Under the terms of settlement agreements Glenmark will be able to market and distribute its atovaquone/proguanil 250mg/100mg tablets under a royalty bearing licence from GSK in the third quarter of 2011, or earlier under certain circumstances.

"Glenmark believes that it is entitled to 180 days of exclusivity with respect to its atovaquone/proguanil 250mg/100mg tablets as the first generic to file an ANDA for the product," the company said.

According to IMS Health sales data, for the 12 months ended December 2009, Malarone tablets reported sales of $56 million in the US market.
   
Glenmark markets 67 generic products in the US market and has filed 39 ANDAs with the US FDA for approval.

Shares of Glenmark Pharmaceuticals were trading at Rs 321 on BSE in the late afternoon trade, up 3.90 per cent from its previous close.