JERUSALEM — Teva Pharmaceutical Industries Ltd. later this year plans to roll out lamivudine and zidovudine tablets, an HIV medication.
Israel-based Teva said Thursday that the Food and Drug Administration has granted approval for the company’s abbreviated new drug application (ANDA) to market a generic version of ViiV Healthcare Co.’s Combivir Tablets.
Plans call for Teva’s product to begin shipping in the fourth quarter 2011, as per the terms of a settlement agreement between Teva and Glaxo Group Ltd. and ViiV Healthcare.
The branded product has annual sales of approximately $315 million in the United States, based on IMS Health sales data provided by Teva.
Teva noted that as the first company to file an ANDA containing paragraph IV certification for these products, it is eligible for a 180-day period of marketing exclusivity.
