Drug major Ranbaxy Laboratories Ltd has received US health regulator’s approval to market generic version of Novartis’ Diovan tablets, used for treating high blood pressure and heart failure, in the US market with 180-days of marketing exclusivity.
The drug should add about $200 million to Ranbaxy’s sales and $100 million to its profit after tax during the exclusive sale period, said Praful Bohra, a senior research analyst at Mumbai-based brokerage Nirmal Bang.
Swiss drugmaker Novartis 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.
Ohm Laboratories Inc, a wholly-owned subsidiary of Ranbaxy has received approval from the US Food and Drug Administration (USFDA) for manufacturing and marketing Valsartan tablets in strengths of 40 mg, 80 mg, 160 mg, and 320 mg on an exclusive basis, Ranbaxy Laboratories said in a statement.
“The Office of Generic Drugs, USFDA, has determined the Ohm formulation to be bio-equivalent and have the same therapeutic effect as that of the branded drug Diovan,” it added.
According to IMS-MAT sales data for April 2014, the total annual market sales for Diovan stood at USD 2.19 billion.
“Ohm is pleased to announce this first-to-file FDA approval for Valsartan tablets, which will be introduced to all classes of trade, with 180-days marketing exclusivity, as soon as sufficient supplies are manufactured to meet the needs of the market,” Ohm Laboratories Vice President, Sales and Distribution, North America, Bill Winter said.
Valsartan will be manufactured at Ohm facilities located in New Brunswick, New Jersey, he added.
North Brunswick-based Ohm Laboratories is engaged in the manufacturing, sale and distribution of generic, branded and over-the-counter products in the US healthcare system.
Ranbaxy’s shares were trading 5.78 per cent up at Rs 499 apiece on the BSE in morning trade. (With Reuters inputs)