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A US court has upheld the decision by the US Food and Drug Administration (FDA) to cancel the approvals given to Ranbaxy to sell and market the generic versions of AstraZeneca’s heartburn medicine Nexium and Roche’s anti-viral medicine Valcyte.
In November 2014, the US FDA had revoked the approvals to Ranbaxy to launch the first generic versions of these medicines in 2008.
Ranbaxy had sued the FDA in the DC Federal Court over this decision and requested it to restrain FDA from allowing other companies to manufacture the generic versions of both Valcyte and Nexium.
The court, however, has upheld FDA’s decision to revoke the approval as well as 180-days marketing exclusivity.
“The court has now issued an opinion indicating that it was (i) denying Ranbaxy's request for preliminary injunction and (ii) granting defendants' requests for summary judgment on the merits. In effect, the court's decision upheld the status quo that FDA had created by rescinding Ranbaxy's tentative approvals and forfeiting our 180-day exclusivities on Valganciclovir and Esomeprazole in November 2014”, Ranbaxy informed the BSE on Tuesday.
The annual sales of Nexium in the US are estimated at $6 billion, while the figure for Valcyte stands at over $400 million.
Ranbaxy stood to make massive gains with the 180-day exclusivity for the first generic versions of these drugs.
This opportunity, however, will now befall other generic manufacturers.
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