Updated on 29 January 2015
Teva pharmaceuticals have received the US FDA nod to prepare and sell blockbuster Nexium
Singapore: In a filing to the BSE, Indian drug major, Ranbaxy, said that the US FDA had recently communicated to the company that it has lost its 180-day exclusivity to sell generic version of AstraZeneca Plc's heartburn drug Nexium in the US market.
The company said in a statement, "We have now received a communication from US FDA that they have determined that Ranbaxy has forfeited its 180-day exclusivity for esomeprazole magnesium delayed release capsule 20 mg and 40 mg."
Nexium, known chemically as esomeprazole, is used to treat heart burn and gastroesophageal reflux disease (GERD).
IMS estimates that the annual sales of the drug is approximately $6 billion in the US. Ranbaxy said that it was pursuing all legal options to preserve its exclusivity.
Meanwhile, sources suggest that Israel-based Teva Pharmaceutical Industries has received an approval from US FDA to manufacture and sell the blockbuster Nexium.