100 Patents Held by 10 Large Drugmakers Challenged by FTC

Ten major pharmaceutical companies will be receiving letters from the FTC challenging the accuracy or proper listing of more than 100 patents listed in the FDA’s Orange Book, which catalogs approved drugs with therapeutic equivalence evaluations.

The 10 companies include AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva and involve patents for Abbvie’s Restasis Multidose, AstraZeneca’s Symbicort, asthma inhalers, epinephrine autoinjectors, and other drug products.

The FTC has notified the FDA “that it disputes the accuracy or relevance of the listed information for these patents, which may require that the manufacturers remove the listing or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.”

Read the FTC’s letters to the companies here.

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