ArticleJournal of managed care & specialty pharmacy2025
Frequency of first generic drugs approved through "skinny labeling," 2021 to 2023.
Article in Journal of managed care & specialty pharmacy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Abstract
backgroundBrand-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.
objectiveTo determine how the use of the skinny labeling pathway by generic prescription drug manufacturers has changed in recent years.
methodsBased 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 (
resultsFrom 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.
conclusionsPrevious 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
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