A United States court has denied a request by home-grown drugmaker Ranbaxy Laboratories to stop competitors from launching copies of AstraZeneca's heartburn pill Nexium and Roche's antiviral Valcyte, a court filing showed.
Ranbaxy had sought the restraining order against Dr Reddy's Laboratories and US-based firm Endo International in a lawsuit it filed against the US Food and Drug Administration (FDA) last week for revoking tentative approvals to launch copies of the two drugs in the US, the drugmaker's largest market.
US District Judge Beryl Howell in Minneapolis denied the drug firm's request, the court filing showed. Ranbaxy, which is being acquired by larger local rival Sun Pharmaceutical Industries for US $3.2 billion, declined to comment on the case.
Analysts had expected generic Nexium to add about US $150 million to the drugmaker's overall sales in the first six months of its launch, while generic antiviral Valcyte was seen adding about US $50 million to sales.
In early November, the US drug regulator told Ranbaxy that it had made an error in granting the company tentative approval to launch the drugs, citing manufacturing quality lapses at the company's domestic plants.
Ranbaxy and the FDA have until November 21 to submit a schedule for further proceedings in the case, the filing showed.
Ranbaxy shares were trading 2.5 per cent higher at Rs 617 a piece at 10:51 am on Thursday.