Ranbaxy Laboratories, the company in waiting to be merged with Sun Pharma, has taken a legal recourse against the US drug regulator for revoking the tentative approvals granted for launching the generic versions of AstraZeneca's heartburn drug Nexium and Roche's antiviral Valcyte in the US.
According to analysts, Ranbaxy could have gained $250 million had the company received the drug regulator's nod to launch both the drugs for six months exclusivity period.
According to a Reuters report, Ranbaxy has filed a law suit in the District Court for the District of Columbia against the US Food and Drug Administration (FDA) and has also said, "The FDA's move violated constitutional rights, exceeded the agency's statutory authority, and was "arbitrary, capricious, and otherwise contrary to law. The FDA has no power to correct an alleged mistake it made six years ago."
However, email query sent by dna to Ranbaxy spokesperson did not elicit any comment on the media report.
Early this month, Gurgaon-based Ranbaxy had said that US FDA has cancelled the tentative approvals given to the company to launch generic Nexium and Valcyte. Ranbaxy in its notification on the BSE had also said, "FDA has said that its original decisions granting tentative approvals were in "error" because of the compliance status of the facilities referenced in the abbreviated new drug applications (ANDAs) at the time the tentative approvals were granted." Ranbaxy held the approval for both drugs even though all its four manufacturing facilities in India are currently having an import ban by the FDA.
While in case of Valcyte, FDA has striped Ranbaxy's 180-days market exclusivity eligibility, it is yet to have a clarity on whether the same also holds for Nexium. According to a pharma analyst, the first six months of market exclusivity for Valcyte would have contributed for $50-70 million.
Soon after revoking approvals to Ranbaxy, FDA approved Hyderabad-based Dr Reddy's Laboratories and the US-based Endo International to launch generic Valcyte. At the moment, there is no other company with market exclusivity for Valcyte generic.
A Dr Reddy's spokesperson had earlier confirmed the approval by FDA and said that the launch is expected shortly in the US.
However, according to Reuters, Ranbaxy in the lawsuit also requested the court to restrain FDA from approving any other generic versions of Valcyte or Nexium until the end of its six-month exclusive periods on the launch of the drugs.
Sarabjit Kour Nangra, VP research - pharma, Angel Broking, said, "While one of its first kinds, the outcome of the case will be very important for Ranbaxy, as these drugs were expected to gross good revenue and profitability for the company."
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