COURT AFFIRMS TEVA'S GENERIC ZOCOR EXCLUSIVITY

Israeli drugmaker Teva Pharmaceutical Industries announced that the U.S. Court of Appeals for the Federal Circuit has affirmed a May 1 decision by a district court awarding the company 180-day exclusivity for its generic version of Merck's Zocor (simvastatin) tablets.

Teva received final approval in June to market its simvastatin tablets, 5, 10, 20 and 40 mg, and immediately began shipping these products. As the first company to file an abbreviated new drug application containing a paragraph IV certification for these dosage strengths, Teva was eligible to receive 180-day Hatch-Waxman statutory exclusivity to market these products. The exclusivity period will last through Dec. 20.

Teva is among the top 20 pharmaceutical companies in the world and is the leading generic manufacturer, according to the company. More than 80 percent of Teva's sales are in North America and Europe.