Teva Pharmaceutical Industries Ltd. began shipment of its quinapril HCl tablets in 5 mg, 10 mg, 20 mg and 40 mg doses. The generic is manufactured pursuant to Ranbaxy's abbreviated new drug application and will be sold under a Teva label and marketed by Teva USA. Quinapril HCl tablets are the AB-rated generic equivalent of Parke-Davis' antihypertensive Accupril, with annual sales of approximately $555 million. The launch followed Teva's relinquishment of its 180-day marketing exclusivity for the drug after it was granted final approval in 2003.
Teva also received tentative approval for the sale of metformin HCl extended-release tablets, the generic version of Bristol-Myers Squibb's Glucophage for treatment of type 2 diabetes, with annual sales of approximately $27 million. It also was granted tentative approval for its ANDA for oxycodone HCl extended-release tablets in 10 mg, 20 mg and 40 mg doses. The drug is the AB-rated generic equivalent of Purdue Pharma's OxyContin for the management of moderate-to-severe pain.
Teva completed its cash acquisition of Pfizer's Italian generic drug arm, Dorom. Teva Italy will integrate Dorom's business with its own, with the combined company producing a product portfolio of 77 generic products for the Italian market and 63 generic products in the pipeline.
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