FTC Challenges Over 100 Patents Listed on FDA’s Orange Book
09 Nov 2023
Pictured: Doorway sign at the FTC building/iStock, Gromit702
The Federal Trade Commission is challenging over 100 patents currently held by the makers of epinephrine autoinjectors, asthma inhalers and other drugs that are “improperly or inaccurately listed” on the FDA’s Orange Book, the regulator announced Tuesday.
The FTC has issued letters to 10 drugmakers including AbbVie, AstraZeneca, GSK, Mylan, Boehringer Ingelheim, Impax Laboratories, and Kaleo, as well as subsidiaries of Teva and GSK. According to the FTC, the letters dispute the notifications provided to the FDA and show the specific patents that it has determined are “improperly listed” on the Orange Book—which identifies drug products approved on the basis of safety and effectiveness.
The products that are in dispute include multiple asthma treatments and inhalers, including Symbicort, Spiriva, Combivent Respimat, Atrovent HFA, Advair HFA, Flovent HFA, as well as epinephrine injectors EpiPen and EpiPen JR.
“Wrongfully listed patents can significantly drive up the prices Americans must pay for medicines and drug products while undermining fair and honest competition,” FTC Chair Lina Khan said in a statement. “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.”
The FTC notified the FDA that it is disputing the “accuracy or relevance” of the listed information for the patents. This action may require the drugmakers to remove the listing entirely or certify listings comply with specific regulatory requirements. The FDA will also send a statement of dispute to the individual New Drug Application (NDA) holders, who have 30 days to withdraw or amend their listings under penalty of perjury.
“The FDA reminds all NDA holders they are obligated to ensure that patent listings comply with statutory and regulatory requirements and to substantively respond to statements of dispute provided under the FDA’s patent listing dispute process,” Commissioner Robert Califf said in a statement.
The move from the FTC comes after issuing a policy statement in October 2023 that stated it would be going after “improper submission” of patents for listing in the Orange Book.
The policy statement also notified pharma and manufacturers that the costs associated with challenging patents may be considered improper, which could lead to disinterest in making generic drug products and not allow for more generic alternatives to be available on the market.
“Boehringer Ingelheim follows all FDA regulations regarding the listing of patents in the Orange Book, including combination drug-device products such as inhalers. Orange Book listings include not only the drug ingredient but also the drug delivery system such as inhalers, which is criteria set forth by FDA,” a Boehringer Ingelheim spokesperson said in an emailed statement to BioSpace.
A Teva spokesperson told BioSpace in an email that the company had received a letter of notification from the FTC and is reviewing it “to determine what the letter entails and any next steps.” The other manufacturers did not immediately respond to the query, though GSK indicated in an email response that it is “aware of the notice.”
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-Drugs
-Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.