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

Author:

Tu S. Sean1,Nagar Sarosh2,Kesselheim Aaron S.2,Lu Zhigang2,Rome Benjamin N.2

Affiliation:

1. West Virginia University College of Law, Morgantown

2. Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, Boston, Massachusetts

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.

Publisher

American Medical Association (AMA)

Subject

General Medicine

Reference5 articles.

1. Spending for orphan indications among top-selling orphan drugs approved to treat common diseases.;Chua;Health Aff (Millwood),2021

2. FDA approval and regulation of pharmaceuticals, 1983-2018.;Darrow;JAMA,2020

3. Trends in prescription drug launch prices, 2008-2021.;Rome;JAMA,2022

4. Reforming the Orphan Drug Act for the 21st century.;Sarpatwari;N Engl J Med,2019

5. Pearson? SD, Dreitlein? WB, Henshall? C. Indication-Specific Pricing of Pharmaceuticals in the United States Health Care System. Institute for Clinical and Economic Review. Published March 2016. Accessed January 20, 2023. https://icerorg.wpengine.com/wp-content/uploads/2020/11/Final-Report-2015-ICER-Policy-Summit-on-Indication-specific-Pricing-March-2016_revised-icons-002.pdf

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