Generic Pharmaceutical Products: A Brief Overview

The FDA is authorized to evaluate and approve generic versions of brand-name pharmaceutical products.

A generic pharmaceutical product17:

  • Contains the same active ingredients as the brand-name reference listed drug
  • Is identical to the brand-name reference listed drug with respect to strength and dosage
  • Meets the same FDA standards of quality, purity, and stability as a brand-name product18

All FDA-approved generic products, including oral contraceptives, undergo a strict and regulated approval process. A generic product meets the criteria for bioequivalence if the rate and extent of its absorption are not substantially different from that of the brand-name reference listed drug. In other words, the products must demonstrate equivalent drug concentration-time profiles in the blood. All Teva Generics oral contraceptives are bioequivalent and interchangeable with their respective brand-name products.17

Use of Generics Results in Dramatic Cost Savings

Nearly 9 of every 10 prescriptions filled in the United States are generic.19 Generic drugs, which cost significantly less than their brand-name counterparts, saved the US health system nearly $1.68 trillion from 2005 to 2014.19 In fact, generic drug products decreased overall healthcare costs by $254 billion in 2014 alone.19

Annual Generic Drug Savings by Year (2005-2014)