The US Federal Trade Commission broke new ground in sending letters to 10 drug manufacturers claiming they improperly listed patents in the US Food and Drug Administration’s Orange Book. The agency did not give any explanation for its assessments or offer an opportunity for comment.
Key Takeaways
- FTC is using the FDA Orange Book dispute process to try to get the patents removed.
The patents pertain to drug-device combination products, including asthma inhalers, epinephrine autoinjectors, and Restasis Multidose eye drops. (See table below).