Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation

JAMA, Vol. 329(18), p. 1607-1608, 2023 doi:10.1001/jama.2023.3079

WVU College of Law Research Paper, No. 2023-014

Posted: 19 Jul 2023 Last revised: 9 Sep 2023

See all articles by S. Sean Tu

S. Sean Tu

West Virginia University College of Law; Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital; Georgetown University - The O'Neill Institute for National and Global Health Law

Sarosh Nagar

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School

Zhigang Lu

Harvard University - Division of Pharmacoepidemiology and Pharmacoeconomics

Benjamin N. Rome

Independent

Date Written: May 1, 2023

Abstract

This study evaluates sales revenue earned in the first 5 years for newly marketed brand-name drugs with and without an initial orphan drug designation.

Keywords: Orphan Drug Act, pharmaceutical investment, statutory incentive, FDA, Orphan Drug Designations and Approvals

JEL Classification: K11, K10, K23

Suggested Citation

Tu, Shine (Sean) and Nagar, Sarosh and Kesselheim, Aaron S. and Lu, Zhigang and Rome, Benjamin N., Five-Year Sales for Newly Marketed Prescription Drugs With and Without Initial Orphan Drug Act Designation (May 1, 2023). JAMA, Vol. 329(18), p. 1607-1608, 2023 doi:10.1001/jama.2023.3079, WVU College of Law Research Paper, No. 2023-014, Available at SSRN: https://ssrn.com/abstract=4510296

Shine (Sean) Tu (Contact Author)

West Virginia University College of Law ( email )

101 Law School Drive
Morgantown, WV West Virginia 26506
United States

HOME PAGE: http://https://www.law.wvu.edu/faculty-staff/faculty/s-sean-tu

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital ( email )

1620 Tremont St.
Suite 3012
Boston, MA 02120
United States

HOME PAGE: http://https://www.portalresearch.org/sean-tu.html

Georgetown University - The O'Neill Institute for National and Global Health Law ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States

HOME PAGE: http://https://oneill.law.georgetown.edu/experts/s-sean-tu/

Sarosh Nagar

Program On Regulation, Therapeutics, And Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School ( email )

Aaron S. Kesselheim

Brigham and Women's Hospital/Harvard Medical School ( email )

1620 Tremont St
Suite 3030
Boston, MA 02120
United States
617-278-0930 (Phone)
617-232-8602 (Fax)

HOME PAGE: http://www.PORTALresearch.org

Zhigang Lu

Harvard University - Division of Pharmacoepidemiology and Pharmacoeconomics

United States

Benjamin N. Rome

Independent ( email )

Do you have a job opening that you would like to promote on SSRN?

Paper statistics

Abstract Views
244
PlumX Metrics