Andrx Gets FDA Approval to Produce Prilosec Generic

Andrx Corp. won U.S. approval for its generic version of AstraZeneca’s ulcer medicine Prilosec, the world’s best-selling drug and the subject of protracted litigation between the two companies.

The Food and Drug Administration approved Andrx’s copy of the delayed-release Prilosec in 10-, 20-and 40-milligram doses. Andrx will wait for a decision in a New York federal drug-patent trial that starts Dec. 6 before marketing the drug, said Elliot Hahn, Andrx’s president and chief executive.

Analysts expect Andrx to introduce its version of Prilosec, which had sales of more than $6 billion last year, by mid-2002. Although one of the patents at the heart of the lawsuit expired last month, the generic-drug producer would risk monetary damages if AstraZeneca wins the court case after Fort Lauderdale, Fla.-based Andrx starts selling its versions.

“We are entitled to start selling the drug now, but Andrx has indicated that, with the trial imminent, we will await the district court’s decision,” Hahn said.

Andrx expects to be able to market its 40-milligram version of the drug for 180 days before a competing generic can be introduced, a right the FDA grants to the first generic-drug maker to file for approval to sell a copy of a brand-name medicine. Andrx said the FDA granted “co-marketing exclusivity rights” with Genpharm International Inc. on the other two versions.

AstraZeneca is Europe’s second-largest pharmaceutical company. Prilosec, also called Losec in many markets, accounts for about 40% of AstraZeneca’s sales. The company is trying to keep generic versions off the market until it finds new products to replace that revenue.

Andrx shares closed up 57 cents at $63.45 on Nasdaq. AstraZeneca closed up 62 cents at $46.35 on the New York Stock Exchange.