The U.S. Federal Trade Commission is formally investigating Teva Pharmaceuticals after the company refused to remove approximately two dozen patents for asthma and COPD inhalers from a key federal registry.
The agency sent a civil investigate demand requiring Teva to provide information related to the patents listed in the so-called Orange Book, which is maintained by the U.S. Food and Drug Administration. The move comes after the FTC late last year began warning Teva and several other companies that they should remove hundreds of “improperly or inaccurately” listed patents or face further action.
The FTC has argued Teva and these other companies listed patents in the Orange Book without properly claiming certain key information, such as a drug substance or method for using a drug. Industry critics say the tactic makes it harder for generic companies to sell lower-cost alternatives to Americans and has been blamed by several congressional lawmakers for keeping prices high.
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