Teva Pharmaceutical Industries has been granted the first approval to market a generic version of the HIV drug Combivir.
The branded version of Combivir (zidovudine and lamivudine) is currently marketed by ViiV Healthcare, GlaxoSmithKline and Pfizer's HIV joint venture. It has annual US sales of around $315 million, according to IMS data.
Now the US Food and Drug Administration has given the green light to Teva's copycat version. Shipment is expected to commence during the fourth quarter of 2011, as per the terms of a settlement between Teva, GSK and ViiV.
As the first company to file an Abbreviated New Drug Application for generic Combivir, the Israeli drugmaker is eligible for a 180-day period of marketing exclusivity.