Ranbaxy gets tentative FDA nod for ulcer drug

NEW DELHI: Ranbaxy Laboratories has received tentative approval from the US Food and Drug Administration (FDA) to market Esomeprazole, the generic copies of Astrazeneca’s blockbuster drug Nexium in 20 mg (base) and 40 mg (base) dosages.

Nexium is the second largest selling drug in the world and has annual sales of $5.5 billion in the US market alone.

Ranbaxy Laboratories will have to first file (FTF) application for the drug, which means that the Indian company will get 180 days marketing rights with no competition from any generic companies upon final approval from the US regulator.

FTF provides generic companies with a significant revenue upside and according to some estimates the drug can rake in around $800 million for the company.

Ranbaxy Laboratories is also fighting legal cases with Pfizer to launch the generic copies of Lipitor, the world’s largest selling drug, with a 180 day marketing exclusivity. The company has around 18 FTF application in the US, the second highest after Israel’s Teva, which has a market size of $20 billion at the innovators’ price.

Astrazeneca has filed patent infringement case against Ranbaxy Laboratories to prevent the drug’s launch. Besides Ranbaxy Laboratories, another Indian company Dr Reddy’s Laboratories (DRL) and Israel’s Teva are also planning to sell generic versions of Nexium, although they do not have the FTF status.