Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”-Reference-Cited by-同舟云学术

Preserving Timely Generic Drug Competition with Legislation on “Skinny Labeling”

Published:2023-10-24 Issue:1 Volume:115 Page:22-24
ISSN:0009-9236
Container-title:Clinical Pharmacology & Therapeutics
language:en
Short-container-title:Clin Pharma and Therapeutics

Author:

Tu S. Sean¹^ORCID,Kesselheim Aaron S.²^ORCID

Affiliation:

1. West Virginia University College of Law Morgantown West Virginia USA

2. Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine Brigham and Women's Hospital/Harvard Medical School Boston Massachusetts USA

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.

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.3075

Reference8 articles.

1. Prices of Generic Drugs Associated with Numbers of Manufacturers

2. Frequency of First Generic Drug Approvals With “Skinny Labels” in the United States

3. Egilman A.C.et al.Frequency of Approval and Marketing of Biosimilars with a Skinny Lael and Associated Medicare Savings.

4. A “Method of Use” to Prevent Generic and Biosimilar Market Entry

5. GlaxoSmithKline LLC. v. Teva Pharms. USA 313 F.Supp. 3d 582(2018).