Frequency of first generic drugs approved through “skinny labeling,” 2021 to 2023
Year: 2025
Type: article
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: ) 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: 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.
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W4408926989