Ranbaxy gets approval for Nexium drug

New Delhi: Ranbaxy Laboratories Ltd has received tentative approval from the US Food and Drug Administration for generic Nexium, Astra Zeneca’s blockbuster drug.

The approval is for capsules of esomeprazole magnesium delayed-release in two strengths, 20 mg and 40 mg, and is the second largest selling in the US with total annual market sales of about $5.5 billion, said the company.

Ranbaxy believes that it has a First to File status on the drug, which could provide it with a potential 180 days marketing exclusivity, bringing significant opportunities in the future. And international market reactions have indicated Ranbaxy may have a strong case. Shares of Astra Zeneca dropped on news of Ranbaxy’s tentative approval. In the recent past Ranbaxy has also settled similar patent disputes with innovator companies. The company claims to have 17 prospective First to Files opportunities