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

Anders OlsenReed F BeallRyan P Knox S Sean Tu Aaron S Kesselheim William B Feldman

Published in: PLoS medicine (2023)

Among several strategies that insulin manufacturers have employed to extend periods of market exclusivity on brand-name insulin products are filing patents after FDA approval and obtaining a large number of patents on delivery devices. Policy reforms are needed to promote timely competition in the pharmaceutical market and ensure that patients have access to low-cost drugs.

Keyphrases

type diabetes
low cost
glycemic control
end stage renal disease
ejection fraction
newly diagnosed
health insurance
public health
mental health
drug administration
skeletal muscle
adverse drug