North America Generic Drugs Market Report and Forecast 2025-2034

North America Generic Drugs Market Analysis

Generic drugs are a chemical copy of brand-name medications, containing the same active ingredients and offering similar clinical benefits. Generic medications also have to go through a shortened United States Food and Drug Administration (FDA) approval process before they can be marketed in the United States. Recent data reveals that 9 out of 10  prescriptions in the United States are filled for generic drugs, indicating their widespread use. There is a rising demand for cost-effective medications by both the healthcare systems as well as the patients to manage medical expenses, which is expected to propel the North America generic drugs market growth.

In North America, the rising burden of chronic diseases and the growing aging population significantly contribute to the global generic drugs market expansion. Further, the increasing patent expiration of branded drugs is a major growth driver for generic medications, allowing generic drug manufacturers to produce and market cheaper versions of formerly patented medications. For instance, Takeda Pharmaceutical’s  patent for lisdexamfetamine dimesylate (Vyvanse) indicated for attention-deficit/hyperactivity disorder (ADHD) in children and adults, and binge-eating disorder (BED) in adults, expired on February 24, 2023, with a pediatric exclusivity period ending on August 24, 2023. It was reported that the FDA approved several first generics of Vyvanse  following the end of the market exclusivity period of the original drug. Thus, the rising patent expiration of brand-name medications is anticipated to boost the North America generic drugs market share.

The market is also influenced by the presence of a favorable regulatory environment that fosters faster approvals and ensures market access to these low-cost drug alternatives. The FDA’s Office of Generic Drugs revealed a significant increase in generic drug approvals in its 2023 Annual Report, with 956 abbreviated new drug applications (ANDAs) including 90 first generics.  Additionally, the surge in first-time generic drug approvals by the FDA, indicated by 12 such approvals in Q1 2024  alone, reflects the rapid market expansion of generic drugs.

North America Generic Drugs Market Report Snapshots

North America Generic Drugs Market Size

North America Generic Drugs Market Analysis

North America Generic Drugs Companies