Exhibit 2: Patents per inhaler at FDA approval, 1986-2020.
Source: FDA Orange Book, Drugs@FDA, authors’ analysis
This figure includes patents granted to inhalers that were filed prior to FDA approval. The median number of pre-approval patents grew from 2 per inhaler (interquartile range [IQR] 1-5) from 1986-1997 to 9 per inhaler (IQR 6-12) from 1998-2008 and 12 per inhaler (IQR 6.5-19.5) from 2009-2020.