Why You Should Know About Generic Drugs in the US

Generic Drugs in the United States

In the United States, 9 out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which then helps to make treatment more affordable and increases access to healthcare for more patients. Learn more about the FDA Drug Competition Action Plan.

The FDA’s Office of Generic Drugs (OGD) within the Center for Drug Evaluation in Research ensures high-quality, affordable generic drugs are available to the American public by following a rigorous review process that includes:

• Managing the regulatory process to facilitate drug approvals,
• Establishing science initiatives to research generic drugs,
• Publishing data and reports on generic drug development and review, and
• Offering educational materials and information.

Overview & Basics

Information about the generic drug review process, FDA standards and pricing, and answers to frequently asked questions

Industry Resources

Electronic submission forms, requirements, guidance, reports, and other resources to help facilitate generic drug applications and approvals

Approvals & Reports

First-time generic drug approvals, generic drug application review metrics, and Generic Drugs Program reports

Science & Research

FDA generic drug regulatory science initiatives, research priorities and reports, public workshops, and opportunities for collaboration

Patient Education

Infographics, brochures, handouts, posters, presentations, PSAs, and articles about generic drugs for educators, health care professionals, and consumers

More from the Office of Generic Drugs

• Complex Generics News
• Generic Drugs Program Activities Metrics
• Recent First Generic Drug Approvals
• Office of Generic Drugs (OGD) Annual Reports
• Generic Drug User Fee Amendments