FDA Approves Generic Version of Prilosec

The FDA Friday approved Andrx Corp.'s generic version of Prilosec, the popular heartburn drug manufactured by AstraZeneca PLC, the Wall Street Journal reports. With $6.2 billion in global sales last year, Prilosec was last year's top selling prescription medication, and is the focus of a debate over "legal and regulatory moves by some major drug companies to delay generic competition against blockbuster drugs." AstraZeneca has waged a "years-long campaign to extend its exclusive hold on Prilosec" that included "nearly a dozen lawsuits against generics makers" and the filing of several additional patents for its drug. On Thursday, governors from 18 states sent a letter to HHS requesting the FDA "ignore [AstraZeneca's] tactics and move quickly to approve a generic version" of the drug. According to a survey by Business for Affordable Medicine, a self-funded coalition of large purchasers of prescription drugs, states paid more than $700 million through their Medicaid programs for Prilosec last year. Gov. Howard Dean (D-Vt.), leader of a bipartisan fight for increasing access to generic drugs, said that having a generic form of Prilosec on the market could save states approximately $300 million per year. He said, "These numbers are just astronomical. This is taking a terrible toll on state budgets and we're all being victimized." AstraZeneca spokesperson Rachel Bloom-Baglin said that her company will "continue to defend [its] intellectual property rights vigorously." Andrx spokesperson Elliot Hahn said that the company will not introduce the generic to market "until patent litigation initiated by AstraZeneca is resolved." As FDA rules prohibit any other drug maker from launching its generic before Andrx, it "loses little by waiting," whereas if it released the generic and lost a lawsuit, the company could have to pay damages (Zimmerman/Rodgers, Wall Street Journal, 11/19).