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- Title
Preserving Timely Generic Drug Competition with Legislation on "Skinny Labeling".
- Authors
Tu, S. Sean; Kesselheim, Aaron S.
- 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 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.
- Subjects
GENERIC drugs; GENERIC drug manufacturing; DRUG patents; DRUG labeling; PHARMACEUTICAL industry; DRUG utilization; PATENTS
- Publication
Clinical Pharmacology & Therapeutics, 2024, Vol 115, Issue 1, p22
- ISSN
0009-9236
- Publication type
Article
- DOI
10.1002/cpt.3075