Israel-based Teva Pharma subsidiary, Ivax Pharmaceuticals, will now be able to sell the Nexium generic in 20-mg and 40-mg capsules following USFDA approval for the heartburn medicine from the AstraZeneca stable. The drug had gone off-patent in May last year. Nexium makes about $4 billion in global sales.
Ranbaxy had late last year sued US FDA in a federal court after the regulator stripped it of its 180-day exclusivity on Nexium. An exclusivity on the drug could have added over $170 million to Ranbaxy’s kitty.
Ranbaxy’s loss, meanwhile, could be gain for drug major Cipla, which provides Teva Pharma formulations for Nexium generic.
Following the regulator’s move, Ranbaxy says, “Ranbaxy is disappointed with the result and is pursuing all available legal options to preserve its rights.”
After the FDA move, the company’s shares dropped marginally from their previous close on BSE to end at Rs.706.90 apiece yesterday. Cipla’s shares, on the other hand, soared about 4.62 per cent over their previous close to end at Rs.705.95 apiece.
At present, all domestic plants of the Gurgaon-based Ranbaxy are barred from selling in the US, the biggest drug market in the world. This has led to substantial losses for the company, which is in the process of being acquired by the Dilip Shanghvi-controlled Sun Pharma.
Dr Reddy’s, Sun Pharma and Aurobindo Pharma have also filed abbreviated new drug applications to market the generic version of Nexium in the US market.
Following a patent litigation, AstraZeneca and Ranbaxy had agreed for a settlement on the generic launch of the drug in 2008. According to estimates, Nexium was the second-best-selling drug for AstraZeneca.