US court overturns Ranbaxy's bid to block launch of rival generic drugs

It had sought restraining order against Dr Reddy's, Endo Intl in lawsuit against US FDA

A US 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 anti-viral, a court filing showed.

Ranbaxy had filed a lawsuit against the US Food and Drug Administration (FDA) last week for revoking tentative approvals it gave the company, to make generics of Valcyte and Nexium. Ranbaxy had also sought to prevent Endo International Plc and Dr Reddy’s Laboratories from making the generics, after the FDA gave the two companies approval to launch their own copies.

 

 

Endo said on Thursday it had launched its generic version of Valcyte, prescribed to treat a type of viral infection in AIDS patients.

A spokeswoman for Dr Reddy’s said the company would launch its own generic version of Valcyte “shortly” but declined being more specific.

Ranbaxy, being acquired by larger local rival Sun Pharmaceutical Industries Ltd for $3.2 billion, declined to comment on the case. Valcyte had total US sales of about $440 million in the 12 months ending September 30, Endo said, citing IMS Health data.

Analysts had expected generic Nexium to add about $150 million to Ranbaxy’s overall sales in the first six months after its launch, while generic Valcyte was seen adding about $50 million.

Earlier this month, the FDA told Ranbaxy it had made an error in granting the company tentative approvals to launch the drugs, citing manufacturing quality lapses at Ranbaxy’s India plants.

Ranbaxy and the FDA have until November 21 to submit a schedule for further proceedings in the case, the court filing showed.

 

Ranbaxy shares were up 2.5% at Rs 617 at 10:51 am on Thursday, while the wider Mumbai market was up 0.11%.