The USA’s Federal Trade Commission yesterday revealed it has expanded its campaign against pharmaceutical manufacturers’ improper or inaccurate listing of patents in the Food and Drug Administration’s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma and chronic obstructive pulmonary disease (COPD) drugs.
The Commission sent warning letters to 10 companies and notified the FDA that it disputes the accuracy or relevance of more than 300 Orange Book patent listings across 20 different brand name products. These patent listings are currently listed in the FDA’s publication of “Approved Drug Products with Therapeutic Equivalence Evaluations,” commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.
To promote competition, the FTC said it is disputing these patent listings as improper or inaccurate. Improper Orange Book patent listings can delay cheaper generic alternatives from entering the market, keeping brand name drug prices artificially high.
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