Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity

Harinder Singh Chahal; Annabelle C Fowler; Rinku Patel; Martin Shimer

doi:10.1001/jama.2021.14595

Characteristics and Outcomes of Products Seeking Competitive Generic Therapy Designation and Exclusivity

JAMA. 2021 Nov 9;326(18):1863-1865. doi: 10.1001/jama.2021.14595.

Authors

Harinder Singh Chahal¹, Annabelle C Fowler¹, Rinku Patel², Martin Shimer²

Affiliations

¹ Office of the Commissioner, US Food and Drug Administration, Silver Spring, Maryland.
² Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.

Abstract

This study describes the process used by the US Food and Drug Administration to review potential generic drugs for Competitive Generic Therapy (CGT) designation and marketing exclusivity as well as the characteristics and outcomes of products that have sought CGT designation and exclusivity from 2017-2020.

MeSH terms

Cross-Sectional Studies
Drug Approval / legislation & jurisprudence
Drug Approval / statistics & numerical data*
Drugs, Generic*
United States
United States Food and Drug Administration

Substances

Drugs, Generic