Brand-name market exclusivity for nebulizer therapy to treat asthma and COPD.

Nebulizer therapy is a cornerstone treatment for asthma and chronic obstructive pulmonary disease (COPD). We collected and analyzed all patents and regulatory exclusivities on brand-name nebulizer solutions approved for asthma and COPD from 1986–2020, quantified periods of protection from generic competition, and compared the patenting strategies employed by manufacturers of nebulizer versus inhaler therapy. The median duration of expected protection from generic competition for brand-name nebulizer solutions (n=13) was 7 years (after subtracting time lost to early generic entry), compared to 14 years for inhalers (n=53). Through the end of 2020, brand-name nebulizers faced generic competition for 62% of all follow-up time compared to 0.5% for inhalers. Unlike inhaler manufacturers, which relied heavily on device patents to build extensive patent thickets, manufacturers of nebulizer solutions listed fewer patents overall and relied more on non-device patents. Regulatory reform is critical to help ensure that patients have access to affordable inhaled medications.