Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986-2019.

ABSTRACT:

Background

Insulin is the primary treatment for type 1 and some type 2 diabetes but remains costly in the United States, even though it was discovered more than a century ago. High prices can lead to nonadherence and are often sustained by patents and regulatory exclusivities that limit competition on brand-name products. We sought to examine how manufacturers have used patents and regulatory exclusivities on insulin products approved from 1986 to 2019 to extend periods of market exclusivity.

Methods and findings

We used the publicly available Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) to identify all approved biosynthetic insulin products. Individual products approved under the same New Drug Application (

SUBMITTER: Olsen A 

PROVIDER: S-EPMC10653475 | biostudies-literature | 2023 Nov

REPOSITORIES: biostudies-literature