There is a system called supplementary protection certificates (SPCs) that gives an extension you the monopoly period to account for regulatory approval periods

There is a system called supplementary protection certificates (SPCs) that gives an extension you the monopoly period to account for regulatory approval periods. https://en.wikipedia.org/wiki/Supplementary_protection_certificate https://en.wikipedia.org/wiki/Supplementary_protection_certi... (I haven't checked this link).