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Drug maker Ranbaxy’s troubles with the US Food & Drug Administration (FDA) continue in the new year, with the American regulator allowing Teva Pharma to launch the generic of Nexuim, a heartburn medicine from the AstraZeneca stable.
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 heartburn drug could have added over $170 million to Ranbaxy’s kitty.
At present, all domestic plants of the Gurgaon-based company are barred from selling in the US, the biggest drug market in the world. This has led to substantial losses for Ranbaxy, which is in the process of being acquired by Dilip Shanghvi-controlled Sun Pharma.
Business Standard had in October last year reported that the company might not be able to reap benefits of the key 180-day exclusivity.
ALSO READ: Ranbaxy might lose Nexium exclusivity
US FDA has said Teva’s subsidiary, Ivax Pharmaceuticals, can sell the Nexium generic in 20-mg and 40-mg capsules. The drug had gone off patent in May last year.
“Ranbaxy is disappointed with the result and is pursuing all available legal options to preserve its rights,” the company said in a statement. After the FDA move, the company’s shares were trading weak on Tuesday — at Rs 699, down 1.08% from their previous close on BSE (as of 1:30 pm IST).
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 settlement of the generic launch of the drug in 2008. According to estimates, Nexium was the second-best-selling drug for AstraZeneca.
Ranbaxy has been going through a rough patch for some time now. The company had last year agreed to settle a litigation related to its participation in Texas Medicaid, the US federal-state health care programme focused on people with low incomes. The settlement deal was worth about $40 million. In May 2013, the company had paid a penalty of $500 million to the US Department of Justice, after pleading guilty to felony charges related to drug safety and misrepresenting data to gain quicker approvals. This comprised $150 million for a criminal charge, and forfeiture and $350 million in payments for civil claims.
