India pharmaceutical major, Ranbaxy might see a delay in its launch of generic Lipitor drug as it is yet to get an approval from the US Food and Drugs Administration [FDA] to launch the product in the US market.
The US patent of Pfizer for the `Lipitor' medicine has expired today. Ranbaxy and Watson Pharmaceuticals are the only two firms licensed to sell the product in the next six months. Watson is expected to launch the product this week but Ranbaxy might see a delay as it does not have necessary approval.
Two of Ranbaxy's plants in India situated at Dewas and Paonta Sahib were blacklisted by the US FDA in 2008. The US FDA had also banned sale of 30 drugs as well as the approvals for new ones that are produced at the plant. Ranbaxy might be planning ot produce generic Lipitor from Paonta Sahib and thus might face problems in getting approvals for the product.
Lipitor is estimated to generate about USD 700 million for Ranbaxy during the next six months of exclusive period. Thus if the launch is delayed, it will help rival firm and will affect Ranbaxy's revenue forecast. The last option for the company would be to sell its exclusive rights to another company, which is highly unlikely. Some believe that Ranbaxy will have to pay a penalty to the FDA to get the approval.