Close on the heels of Ranbaxy announcing a patent dispute settlement with Japan’s Takeda Pharmaceuticals for the generic equivalent of Takeda’s drug Actos, Mumbai-based Glenmark Pharmaceuticals said on Monday its US-based group company has settled a patent dispute with GlaxoSmithKline over the launch of a generic version of anti-malaria drug Malarone.

Glenmark Generics Inc has settled the litigation pending between the company and GSK over patent actions concerning Atovaquone and Proguanil hydrochloride 250mg/ 100mg tablets, the generic version of GSK’s Malarone tablets, Glenmark Pharma said in a statement.

Under the terms of the 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, it said.

The settlement agreements are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark said.

“Glenmark believes that it is entitled to 180 days of exclusivity with respect to its Atovaquone / Proguanil 250 mg/100mg tablets as the first generic to file an ANDA for the product,” the company said. GSK currently markets its product as Malarone in the US, for the prevention and treatment of malaria. Total US sales as reported by IMS Health for the 12 month period ended December 31, 2009, were approximately $56 million. Glenmark Generics Inc is the US subsidiary of Glenmark Generics Ltd, which is a subsidiary of Glenmark Pharma. Shares of Glenmark Pharma were down 1.61% to close at Rs 274.35 on the Bombay Stock Exchange (BSE) on Monday.

Last month, Ranbaxy’s US arm, Ranbaxy Pharmaceuticals Inc reached an agreement with Takeda Pharmaceutical Company Ltd and Takeda Pharmaceuticals North America, resolving outstanding patent litigation related to Ranbaxy’s generic equivalent version of Actos (pioglitazone hydrochloride) 15 mg, 30 mg and 45 mg tablets. Under terms of the agreement, Takeda granted Ranbaxy a non-exclusive royalty-free licence to its US patents covering Actos. Under the terms of the agreement, Ranbaxy has certainty in the launch of its generic equivalent formulation of Actos on August 17, 2012, or earlier under certain circumstances. Actos had approximately $3.4 billion in brand sales for the 12 months ended December 31, 2009, according to IMS Health.

One of the most significant out-of-court settlements in recent years took place between Ranbaxy and Pfizer, when, in June 2008, the two agreed to settle their row over Lipitor, the world’s largest-selling drug, with 2007 sales of around $12.7 billion. The settlement was for 12 countries including the US, which accounts for over 50% of the global pharmaceutical sales.