Integrated pharmaceuticals company Dr Reddy's Laboratories has filed for marketing rights to a generic version of Pfizer's cholesterol-lowering drug Lipitor, in the US, reports quoting company sources said.
Dr Reddy's is the only Indian drugmaker after Ranbaxy to develop a generic version of the world's largest-selling drug, whose US patent expires in 2010.
Dr Reddy's is reported to have informed Pfizer about proceeding with plans to apply for marketing rights in the US.
Ranbaxy, which has already arrived at a settlement with Pfizer, is expected to launch its generic by November 2011.
Dr Reddy's along with its US subsidiary will apply to the US Food and Drug Administration (US FDA) for marketing rights to the drug, reports said.
Lipitor, with global sales of $8.3 billion in the last nine months, is the world's largest selling drug.
Established in 2001, Dr Reddy's North American Generics currently markets 41 prescription products in 203 dosing presentations (ie, strengths and package sizes). In addition, Dr Reddy's Private Label OTC Group, which was established in 2007, markets seven different products in 136 packaging presentations.
Dr Reddy's generics business has an aggressive product pipeline - with many products under development and awaiting FDA approval. Over the past 12 months, Dr Reddy's has launched the following important prescription generic products: Sumatriptan (a generic version of Imitrex of Glaxo Smith Kline), Divalproex (a version of Depakote of Abbott), Risperidone (Risperdal - Janssen), Ramipril (Altace - King), Venlafaxine (Effexor -Wyeth), Lamotrigine (Lamictal - Glaxo Smith Kline), and Levetiracetam (Keppra - UCB).
Dr Reddy's North American Generics undertakes everything from process development of active pharmaceutical ingredients (APIs), to formulations and the submissions of ANDAs, to manufacturing of finished dosages, to operations/marketing/sales/customer service - to ensure that the products our customers want and need are delivered on time.