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Preserving Timely Generic Drug Competition with Legislation on "Skinny Labeling".

Authors :
Tu, S. Sean
Kesselheim, Aaron S.
Source :
Clinical Pharmacology & Therapeutics; Jan2024, Vol. 115 Issue 1, p22-24, 3p
Publication Year :
2024

Abstract

Patents prevent generic drug entry. Brand firms file new "method of use" patents for old drugs to prevent generic entry. Congress addressed this issue by creating the "skinny label" pathway, which allows generic firms to use the drug label to indicate that the old drug can only be used for nonā€patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
00099236
Volume :
115
Issue :
1
Database :
Complementary Index
Journal :
Clinical Pharmacology & Therapeutics
Publication Type :
Academic Journal
Accession number :
174271068
Full Text :
https://doi.org/10.1002/cpt.3075