Frequency of first generic drugs approved through "skinny labeling," 2021 to 2023.

IF 2.3 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Therese J Ziaks, Chukwubuikem M Akanegbu, Alexander C Egilman, Aaron S Kesselheim
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引用次数: 0

Abstract

Background: Brand-name drug manufacturers receive a market exclusivity period following US Food and Drug Administration (FDA) approval, which can be extended through obtaining additional patents such as method-of-use patents. The skinny labeling pathway, in which the FDA approves generic prescriptions that carve out patent-protected indications from their labeling, has helped promote competition and timely market entry of low-cost generic prescriptions for many decades.

Objective: To determine how the use of the skinny labeling pathway by generic prescription drug manufacturers has changed in recent years.

Methods: Based on FDA-curated lists, we assessed the proportion of FDA-approved first generic prescriptions using the skinny labeling pathway from 2021 to 2023. We also examined whether the use of the pathway changed after a 2021 federal court decision (GlaxoSmithKline v. Teva) increased the risk of legal liability for generic manufacturers marketing skinny label generic prescriptions.

Results: From 2021 to 2023, 42.9% of 21 susceptible brand-name drugs required a skinny labeled generic prescription, including 5 (56%) in 2021, 3 (43%) in 2022, and 1 (20%) in 2023.

Conclusions: Previous literature found 43% of brand-name drugs experienced skinny labeling generic prescription competition in a 2015-2019 sample, which is consistent with the rate of skinny labeled generic prescription entry early in our sample. Then, the proportion of first generic prescriptions approved with a skinny label decreased annually from 2021 to 2023. Applying this 2021 GlaxoSmithKline v. Teva methodology in subsequent years can help determine whether the judicial decision has had a sustained chilling effect on generic prescription manufacturers' use of skinny labeling, resulting in delayed generic prescription competition as a result of fewer generic prescriptions entering the market.

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来源期刊
Journal of managed care & specialty pharmacy
Journal of managed care & specialty pharmacy Health Professions-Pharmacy
CiteScore
3.50
自引率
4.80%
发文量
131
期刊介绍: JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.
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