Glenmark: Unit Gets FDA OK To Sell Generic Malaria Drug
BANGALORE (Dow Jones)--Glenmark Pharmaceuticals Ltd. (532296.BY) Wednesday said its generic drugs unit has received final approval from the U.S. Food and Drug Administration to sell a generic version of GlaxoSmithKline PLC's (GSK) malaria drug Malarone.
In April 2010, Glenmark settled a patent litigation with GlaxoSmithKline over atovaquone and proguanil hydrochloride 250 milligram/100mg tablets--the generic version of Malarone.
Glenmark can sell the generic tablets under a royalty-bearing license from GlaxoSmithKline in the third quarter of 2011, or earlier under certain circumstances, the Indian company said in April.
Glenmark Wednesday said it is entitled to 180 days of exclusivity on the product as it was the first company to file a generic drug application with the FDA.
U.S. sales of Malarone were about $56 million in the 12 months ended 2009, Glenmark said, citing IMS Health research data.
Jan 25, 2011