Nov 20 (Reuters) - A U.S. court has denied a request by Indian drugmaker Ranbaxy Laboratories Ltd to stop competitors from launching copies of AstraZeneca Plc’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 U.S. firm Endo International Plc in a lawsuit it filed against the U.S. Food and Drug Administration last week for revoking tentative approvals to launch Nexium and Valcyte copies in the United States, its largest market.
U.S. District Judge Beryl Howell in Minneapolis denied Ranbaxy’s request, the court filing showed. The company, which is being acquired by larger local rival Sun Pharmaceutical Industries Ltd for $3.2 billion, declined to comment on the case.
Analysts had expected generic Nexium to add about $150 million to Ranbaxy’s overall sales in the first six months of its launch, while generic Valcyte was seen adding about $50 million to sales.
Earlier this month, the FDA told Ranbaxy it had made an error in granting the company tentative approval to launch the drugs, citing manufacturing quality lapses at Ranbaxy’s India plants.
Ranbaxy and the FDA have until Nov. 21 to submit a schedule for further proceedings in the case, the filing showed.
Ranbaxy shares were down 1.6 percent at 592.90 rupees at 0444 GMT on Thursday, while the wider Mumbai market was up 0.1 percent. (Reporting by Zeba Siddiqui in MUMBAI and Joseph Ax in NEW YORK; Editing by Miral Fahmy)