Teva May Gain Marketing Exclusivity for 26 Products

Teva Pharmaceutical's U.S. generic pipeline currently consists of 140 product applications, 26 of which it hopes to gain marketing exclusivity for, the company said in its fourth-quarter earnings report.

Of the 140 applications filed with the FDA, Teva said 76 were submitted under Paragraph IV. The company said that in the case of 26 of these Paragraph IV applications, it believes it was the first to file an abbreviated new drug application with the agency, which would give the company 180 days of marketing exclusivity for those products. The 26 products have aggregate annual brand sales exceeding $21 billion, Teva said.

Teva's U.S. performance during the fourth quarter was bolstered by sales of 30 new products launched since the fourth quarter of 2003. The company's most significant launches last year were gabapentin, oxycodone and quinapril.

The company's U.S. sales rose 41 percent during the quarter, growing to $769 million from $544 million in the same period of 2003. Teva reported total sales of $1.3 billion for the fourth quarter, up roughly 40 percent from the comparable period of 2003. For the full year 2004, net sales were $4.8 billion, an increase of 46 percent over 2003.