{"id":44510,"date":"2024-04-30T10:18:06","date_gmt":"2024-04-30T14:18:06","guid":{"rendered":"https:\/\/d56fg8tfg.fitnews.club\/finance\/ftc-expands-patent-listing-challenges-targeting-more-than-300-junk-listings-for-diabetes-weight-loss-asthma-and-copd-drugs\/"},"modified":"2024-04-30T10:18:06","modified_gmt":"2024-04-30T14:18:06","slug":"ftc-expands-patent-listing-challenges-targeting-more-than-300-junk-listings-for-diabetes-weight-loss-asthma-and-copd-drugs","status":"publish","type":"post","link":"https:\/\/d56fg8tfg.fitnews.club\/finance\/ftc-expands-patent-listing-challenges-targeting-more-than-300-junk-listings-for-diabetes-weight-loss-asthma-and-copd-drugs\/","title":{"rendered":"FTC Expands Patent Listing Challenges, Targeting More Than 300 Junk Listings for Diabetes, Weight Loss, Asthma and COPD Drugs"},"content":{"rendered":"
Today, the Federal Trade Commission expanded its campaign against pharmaceutical manufacturers\u2019 improper or inaccurate listing of patents in the Food and Drug Administration\u2019s (FDA) Orange Book, disputing junk patent listings for diabetes, weight loss, asthma, and COPD drugs, including Novo Nordisk Inc.\u2019s blockbuster weight-loss drug, Ozempic.<\/p>\n
The Commission sent warning letters to 10 companies<\/a> 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\u2019s publication of \u201cApproved Drug Products with Therapeutic Equivalence Evaluations,\u201d commonly known as the Orange Book, which lists drug products approved by the FDA as safe and effective.<\/p>\n 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.<\/p>\n \u201cBy filing bogus patent listings, pharma companies block competition and inflate the cost of prescription drugs, forcing Americans to pay sky-high prices for medicines they rely on,\u201d said FTC Chair Lina M. Khan. \u201cBy challenging junk patent filings, the FTC is fighting these illegal tactics and making sure that Americans can get timely access to innovative and affordable versions of the medicines they need.\u201d<\/p>\n The warning letters were sent to:<\/p>\n When the listing of a patent is disputed under FDA regulations, as the FTC has done here, the FDA will send the dispute to the branded drug manufacturer who will then have 30 days to withdraw or amend the listing, or certify under penalty of perjury that the listing complies with applicable statutory and regulatory requirements.<\/p>\n \u201cIt is the responsibility of branded drug manufacturers to ensure that Orange Book submissions contain information only on the types of patents for which information should be submitted to FDA,\u201d said FDA Commissioner Robert M. Califf, M.D. \u201cThe FDA will continue to engage with the FTC to identify and address potential efforts to impede competition so that consumers can get access to the medicines they need.\u201d\u00a0<\/p>\n The FTC\u2019s latest patent listing dispute filings come after the Commission\u00a0challenged<\/a> over 100 patent listings in November for medications specific to asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors. The Commission\u2019s November challenges led to Kaleo Inc., Impax Labs, GlaxoSmithKline, and Glaxo Group delisting patents in response to the FTC\u2019s warning letters. Subsequently, AstraZeneca, Boehringer Ingelheim, and GlaxoSmithKline all announced commitments to cap inhaler out-of-pocket costs at $35.<\/p>\n\n