India’s Ranbaxy Laboratories Ltd has received approval from the U.S. FDA (Food and Drug Administration) to launch a cheaper copy of Diovan, Novartis AG’s blood pressure pill, boosting its outlook after a series of regulatory bans for poor production quality at its India facilities hurt investor sentiments.
For $3.2 billion, Ranbaxy is in the process of being acquired by Sun Pharmaceutical Industries Ltd. Ranbaxy will be the first company to launch a copy of Diovan in the United States and will be entitled to six months of exclusivity to sell it.
A senior research analyst at Mumbai-based brokerage Nirmal Bang, Praful Bohra said that the drug should add around $100 million to Ranbaxy’s profit after tax during the exclusive sale period.
Novartis, a Swiss drugmaker lost its patent rights to its once best-selling Diovan in the United States at the end of 2012, but has avoided generic competition because of multiple production quality control problems at Ranbaxy.
Due to violations of its GMP (good manufacturing practices), all of Ranbaxy’s India-based plants have been banned by the FDA from exporting to the United States. A unit of Ranbaxy in New Jersey, Ohm Laboratories, is allowed to make drugs for its largest market.
Over the past year, the FDA has stepped up its scrutiny of pharmaceutical manufacturers in India, which is the biggest supplier of medicines to the United States.
Reservations about quality control issues in India’s $15 billion drug industry came to the fore as multiple plants run by companies including Ranbaxy and Wockhardt Ltd were barred from exporting to the United States.
Vice president at New Jersey-based Ohm Labs, Bill Winter said in a statement the Diovan generic would be launched as soon as sufficient supplies are manufactured to meet the needs of the market.
Ranbaxy did not mention when the generic version of Diovan will be launched. Diovan had global sales of $3.5 billion in 2013.
Ranbaxy was the first company to file with FDA seeking approval to launch generic versions of two other top-selling drugs – Roche’s antiviral Valcyte and AstraZeneca ‘s hugely popular heartburn drug Nexium. Both drugs are pending final approval from the FDA.