The timing of 30-month stay expirations and generic entry: A cohort study of first generics, 2013-2020.

ABSTRACT: Before the first generic version of a drug is marketed, patent litigation often occurs. The process begins when generic manufacturers notify the US Food and Drug Administration (FDA) of their intent to market a generic copy of a brand-name drug protected by patents, which they allege to be invalid or not infringed (called a Paragraph IV certification). Assuming the brand-name manufacturer responds with litigation within 45 days, a 30-month stay period is triggered, which bars the FDA from authorizing generic entry until the stay period expires or litigation is resolved in favor of the generic manufacturer. To understand whether 30-month stays delay generic entry, we examined the timing of major legal events leading to generic entry for a cohort of 46 generic drugs, including the timing of

SUBMITTER: Kannappan S 

PROVIDER: S-EPMC8504843 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature