US court dumps Ranbaxy’s bid to stall launch of rival generics

Ranbaxy Laboratories has lost out in its fight against US Food and Drugs Administration (FDA) in the first bout itself with a US court denying the Indian drug maker's bid to stall release of rival generic drugs in US market as it contested a ban on its own drug.

In what could be a $200 loss over a six month period, FDA has allowed competitors, including India's Reddy's Laboratories, to launch copies of AstraZeneca Plc's heartburn pill Nexium and Roche's antiviral Valcyte, a court filing showed.

In a lawsuit filed against the FDA last week for revoking tentative approvals to launch Nexium and Valcyte copies in the United States, its largest market, Ranbaxy had also sought a restraining order against Dr Reddy's Laboratories and US firm Endo International Plc.

US District Judge Beryl Howell in Minneapolis denied Ranbaxy's request, the court filing showed.

FDA had, earlier this month, told Ranbaxy that it had made an error in granting the company tentative approval to launch the drugs, citing manufacturing quality lapses at Ranbaxy's India plants, exports from which to the US are banned.

Ranbaxy Laboratories, which is in the process of being acquired by Sun Pharma, sued the FDA for arbitrarily revoking its six-month exclusivity licences for Nexium and Valcyte.

Exclusivity licences are given when a branded drug goes off patent to the first company that produces an acceptable generic copycat. While Nexium, owned by AstraZeneca, is used to treat excess production of acid in the stomach (heartburn), Valcyte (owned by Roche) is an anti-viral.

While the FDA's decision to revoke the exclusivity licences to Ranbaxy will reportedly cost the company hugely, the Indian drug maker, which is already under the regulator's mercy, has to be doubly sure to challenge the regulator.

While taking on a regulator is a huge risk in itself, Ranbaxy has even named US health secretary Sylvia Burwell in the lawsuit.