The first generic versions of GlaxoSmithKline’s cardiovascular agent Coreg – all 14 of them – have been approved by US regulators.
The US Food and Drug Administration said the companies – Actavis, Apotex, Aurobindo, Caraco, Dr Reddy’s, Glenmark, Lupin, Mylan, Ranbaxy, Sandoz, Taro, Teva, Watson and Zydus – can sell generic versions of Coreg (carvedilol) in four strengths (3.125 mg, 6.25 mg, 12.5 mg and 25mg).
The agency noted that Coreg was the 30th top selling brand name drug by retail dollars in 2006 so the arrival of copycat versions is clearly going to hurt GSK which banked around $1.7 billion from the treatment for the year ended June 30, based on IMS data. That figure will be cut to pieces and some analysts suggest that the UK-based drugs giant will see its sales of the beta blocker reduced very quickly by as much as 95% as the likes of Teva and Mylan have said that shipments of generic Coreg have already begun.
One saving grace for GSK could be the performance of Coreg CR, an extended-release version of the drug which was approved by the FDA last October. It should have patent protection up to 2023.