North America Generic Drugs Market Report and Forecast (2025-2034)

The North America generic drugs market was valued at USD 177.20 Billion in 2024 driven by the rising demand for cost-effective medications and presence of a favorable regulatory environment. It is expected to grow at a CAGR of 6.80% during the forecast period of 2025-2034, with the values likely to attain USD 342.12 Billion by 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 Segmentation

The report offers a detailed analysis of the market based on the following segments:

Market Breakup by Therapy Area

• Cardiovascular
• Dermatology
• Respiratory
• Oncology
• Rheumatology
• Others

Market Breakup by Route of Administration

• Oral
• Injectables
• Dermal/Topical
• Inhalers
• Others

Market Breakup by Distribution Channels

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
• Others

Market Breakup by Region

• United States
• Canada

Leading Players in the North America Generic Drugs Market

The key features of the market report include patent analysis, grants analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

• Teva Pharmaceutical Industries Ltd
• Viatris Inc.
• Sun Pharmaceutical Industries Ltd
• Lupin
• AstraZeneca
• Baxter
• Takeda Pharmaceutical Company Limited
• GSK plc
• Bausch + Lomb
• Novartis AG
• Sanofi
• Pfizer Inc.
• Fresenius SE & Co. KGaA
• Hikma Pharmaceuticals PLC
• Aurobindo Pharma

Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.
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