The fight continues to get generic versions of Prilosec on the market - Legal News in Brief

Drug Cost Management Report, Nov, 2002

* The fight continues to get generic versions of Prilosec on the market, but the blessed event may be several months away. After 10 months of legal wrangling, three out of four generic drugmakers were found to infringe on AstraZeneca's patents for Prilosec. On Oct. 11, 2002, Judge Barbara S. Jones of the Southern District Court of New York issued an opinion that AstraZeneca's two formulation patents relating to Prilosec[R] (the '230 and '505 patents) are valid.

Andrx, Genpharm and Cheminor Drugs cannot launch their generic versions of Prilosec as anticipated. Another generic drug maker fared better, but the result will not be generic availability of Prilosec. Kremers Urban Development Co. (Kudco) was not found to infringe the claims of AstraZeneca's patents. However, this company has not received final FDA approval for its generic product. That approval awaits the expiration of the 180-day period of exclusivity awarded to Andrx, which is the first generic maker to have received FDA approval for a Prilosec bioequivalent. In anticipation, Andrx had already initiated production and has about $65 million in inventories and purchase commitments for its generic Prilosec. A couple of years ago, Barr Laboratories lost its first challenge of the Eli Lilly Prozac patent in court, but prevailed on appeal. Andrx says it will appeal the New York court's decision and hopes for a similar outcome. Prilosec, with annual U.S. sales of $3.7 billion, leads the class of proton pump inhibitors that represents almost 8% of drug costs for PBMs.