The Federal Patent Court of Germany in Munich handed down a favorable decision for Ranbaxy, invalidating all relevant claims of the European patent 409 281 (281) of the cholesterol-lowering drug marketed by Pfizer as Lipitor.

The drug has annual sales of $137 million (TMS - MAT: June 2007), Ranbaxy said in a filing with the Bombay Stock Exchange (BSE).

"This is an important milestone for Ranbaxy as it reinforces and validates yet again our position in relation to this patent," said Jay Deshmukh, senior vice president, global intellectual property for Ranbaxy Laboratories.

Ranbaxy Pharmacuticals, the US subsidiary of Ranbaxy Laboratories, meanwhile, received tentative approval from the US Food and Drug Administration to make and sell valsartan tablets in multiple strengths.

The tablets are used for the treatment of hypertension and heart failure, the company said in a statement. Total annual market sales for valsartan tablets were $1.3 billion, it said.

The FDA approval allows Ranbaxy to make four different dosages of valsartan tablets, which is also used to treat heart failure. Total annual market sales of valsartan were $1.3 billion.

"We believe we are first to file a substantially complete ANDA (abbreviated new drug application) and will stand to gain from the 180-day exclusivity available to the first filer," said Jim Meehan, vice president of sales and distribution for Ranbaxy Pharmaceuticals.