Drug Firm Sues FDA Over Rival’s Generic

One day after its stock nose-dived, Corona-based Watson Pharmaceuticals said Tuesday that its Florida drug unit is suing federal regulators after they approved a rival generic version of a drug used to treat advanced Parkinson’s disease.

On Monday, Watson shares fell $8.50 to $31.25 on news that the Food and Drug Administration approved a DuPont Merck Pharmaceutical drug to compete with Somerset Pharmaceuticals’ Eldepryl treatment. On Tuesday, Watson shares dipped another 50 cents to close at $30.75 in Nasdaq trading.

Several analysts said Tuesday that the market had overreacted to the news of federal approval of generic rivals of Eldepryl. One analyst, Prem Lachman of Goldman Sachs & Co., issued a “strong buy” rating for Watson.

Tampa, Fla.-based Somerset, jointly owned by Watson and Pittsburgh-based Mylan Laboratories Inc., said it learned that the FDA had approved three drugs--the first generic copies of Eldepryl.

The lawsuit alleges that the three drugs should not have received regulatory approval because they are not “bioequivalent” to Eldepryl. Federal regulations require that generic drugs be bioequivalent to approved drugs on the market, meaning that they have the same therapeutic effect on the body.

Somerset also said in a suit filed in federal court in Delaware that the tablet forms of Eldepryl approved by the FDA are not as therapeutically effective as Somerset’s capsule version of the drug.

FDA officials weren’t immediately available for comment.

The three newly approved drugs are tablet forms of the Parkinson’s disease drug. Somerset, which markets a capsule form, stopped marketing its own tablet form in May because of widespread counterfeiting and confusion in the marketplace.