{"id":43012,"date":"2023-11-07T11:09:22","date_gmt":"2023-11-07T16:09:22","guid":{"rendered":"https:\/\/d56fg8tfg.fitnews.club\/finance\/ftc-challenges-more-than-100-patents-as-improperly-listed-in-the-fdas-orange-book\/"},"modified":"2023-11-07T11:09:22","modified_gmt":"2023-11-07T16:09:22","slug":"ftc-challenges-more-than-100-patents-as-improperly-listed-in-the-fdas-orange-book","status":"publish","type":"post","link":"https:\/\/d56fg8tfg.fitnews.club\/finance\/ftc-challenges-more-than-100-patents-as-improperly-listed-in-the-fdas-orange-book\/","title":{"rendered":"FTC Challenges More Than 100 Patents as Improperly Listed in the FDA\u2019s Orange Book"},"content":{"rendered":"
Today, the Federal Trade Commission (FTC) challenged more than 100 patents held by manufacturers of brand-name asthma inhalers, epinephrine autoinjectors, and other drug products as improperly or inaccurately listed in the Food and Drug Administration\u2019s (FDA) publication of \u201cApproved Drug Products with Therapeutic Equivalence Evaluations,\u201d commonly known as the \u201cOrange Book.\u201d<\/p>\n
The Commission has also notified 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. \u00a0<\/p>\n
The FTC sent notice letters<\/a> to 10 companies, which include: AbbVie, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Impax Laboratories, Kaleo, Mylan Specialty, and subsidiaries of Glaxo-Smith Kline and Teva. The notice letters and the patent listing dispute notifications provided to FDA identify specific patents that FTC contends are improperly listed for specific asthma and other inhaler devices, Restasis multidose bottles, and epinephrine autoinjectors, also commonly known as EpiPens.<\/p>\n \u201cWrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,\u201d said FTC Chair Lina M. Khan. \u201cThe FTC\u2019s action today identifies over 100 patents that we believe are improperly listed, affecting products ranging from inhalers to EpiPens. We will continue to use all our tools to protect Americans from illegal business tactics that are hiking the cost of drugs and drug products.\u201d<\/p>\n When the listing of a drug substance or drug product patent is disputed consistent with the applicable FDA regulations FDA will send the statement of dispute to the New Drug Application (NDA) holder who will then have 30 days to withdraw or amend these listings, or certify under penalty of perjury that the listings comply with applicable statutory and regulatory requirements.<\/p>\n