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

被引：1
|
作者：
Tu, S. Sean [1 ]
Kesselheim, Aaron S. [2 ]
机构：
[1] West Virginia Univ, Coll Law, Morgantown, WV 26506 USA
[2] Harvard Med Sch, Brigham & Womens Hosp, Dept Med, Program Regulat Therapeut & Law PORTAL,Div Pharmac, Boston, MA USA
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2024年 / 115卷 / 01期
关键词：
D O I：
10.1002/cpt.3075
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
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 non-patented uses. This pathway is now in jeopardy due to a recent court case. This paper outlines the issues and suggests possible legislative solutions.
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收藏
页码：22 / 24
页数：3
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