Patenting Strategies on Inhaler Delivery Devices

Among 53 brand‑name inhalers approved for asthma and COPD between 1986 and 2020, 39 products had device patents listed in the FDA’s Orange Book, accounting for nearly half of all listed patents on inhalers. Most device patents (77%) did not mention the inhaler’s active ingredients, and these patents extended market exclusivity by a median of 5.5 years beyond non‑device patents. These broadly scoped device patents can delay generic competition, and the FDA should take action to better align Orange Book patent listings with genuine drug innovation.