Indian pharmaceutical major, Dr. Reddy’s Laboratories (DRL) said on Monday, it had launched Valganciclovir tablets, an anti-viral drug in the U.S. market after receiving U.S. Food and Drug Administration (USFDA) approval.
The product is a therapeutic equivalent generic version of Valcyte made by Roche. A statement from the company said the Valcyte tablets brand has U.S. sales of around $ 440 million for the 12 month period ending October 2014, according to IMS data. Dr. Reddy’s Valganciclovir tablet in 450 mg strength is available in bottle counts of 60, the statement said.
Earlier, the USFDA had granted final approval to Dr. Reddy’s and U.S.-based Endo International to make cheaper copies of Valcyte. But the USFDA had stopped the company of its tentative approval to launch the copy of the drug due to quality control issues at its manufacturing plants. “Ranbaxy, all of whose domestic manufacturing plants have been banned by the USFDA from exporting to the U.S., also lost its rights to six-month exclusivity for Valcyte generic,” Sarabjit Kour Nangra, V-P Research, Angel Broking, said in a report.
“Thus currently apart from DRL, Endo Pharma has the approval for the drug. DRL, which has launched the drug can add at least US$ 60-80 million to the full year sales of the company, if the competition remains low,” Ms. Nangra said.
However, on the Bombay Stock Exchange on Tuesday, DRL stock reacted by 6.32 per cent to close trade at Rs. 3,142.05.
