Wednesday, January 28, 2015
Ranbaxy Laboratories has lost the opportunity to exclusively market in the United States for six months the first generic version of Anglo Swedish drug innovator Astra Zeneca's heartburn drug Nexium, the Delhi-based company said in a filing to the stock exchange on Tuesday.
The company, which is in the process of getting acquired by rival drugmaker Sun Pharmaceutical Industries, said the US Food and Drug Administration (FDA) has "determined that Ranbaxy has forfeited its 180 days exclusivity" for the drug.
"Ranbaxy is disappointed with the result and is pursuing all available legal options to preserve its rights," the company told the BSE. A Ranbaxy spokesperson refused to expand on the matter beyond the company's communication to the bourses.
The USFDA had in November communicated to the company its decision to revoke the tentative approvals for Nexium and Roche's antiviral Valcyte as they were erroneous.
Analysts said the development is negative for the company even as it was expected after the FDA rescinded its tentative approvals late last year. Analysts had expected the company to earn over $160 million through this exclusive marketing opportunity of blockbuster Nexium, which clocks sales of almost $2 billion in the US and $4 billion globally. Ranbaxy's stock ended flat at Rs 706.90 on BSE on Tuesday, up 0.09% since its previous close.
Sarabjit Kour Nangra of Angel Broking said the development is negative for the company.
While striking off Ranbaxy's approval for Nexium, the FDA gave its nod to Israel's Teva Pharma, the agency's first such approval for the drug.
Ranbaxy was expected to launch its low cost version of Nexium in May 2014 and market it till November but had failed to do so.
The delay in launching a low-cost version had prompted the US states, rival generic drugmakers, consumer groups, drug retailers and wholesalers to step up pressure on Ranbaxy to either immediately launch or bow out to allow other generic drugmakers to launch.
Source : http://economictimes.indiatimes.com/
