The development and growth of the generic pharmaceutical industry over the past 30 years has come as a response to rising healthcare costs. Generic pharmaceuticals, which are carefully manufactured formulations of the original, patented "brand name" products, help to make American healthcare more affordable.

What are generic drugs?

Answer:  Generic drugs are identical--or bioequivalent--to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.  Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

When a medicine is first developed, the pharmaceutical company that discovers and markets it receives a patent, which gives the company the sole right to sell the drug while the patent is in effect.  When the patent expires, a generic version of the drug may become available.  Generics meet the same US Food and Drug Administration (FDA) quality and effectiveness standards as the original product.

Are generic drugs as good as brand names?

Answer: Yes.  Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:

  • contains the same active ingredient;
  • is identical in strength, dosage form, and route of administration;
  • has the same indications, dosing, and labeling; and
  • provides the same efficacy and safety profile to patients ("bioequivalent").

Why do generic drugs cost less?

Answer: Generic manufacturers are able to sell their products for lower prices not because the products are of lesser quality, but because generic manufacturers generally do not have significant expenses to recoup, such as research & development costs, since generics are not new drugs.

Are generic drugs as safe as brand-name drugs?

Answer: Yes.  Generic medicines have to be safe and effective to be approved by the FDA.  The FDA also requires generic drug manufacturers to:

  • meet the same batch-to-batch requirements for strength, purity and quality as the original manufacturer; and
  • follow the same strict "Good Manufacturing Practices" rules.

Do generic drugs have the same quality as brand-name drugs?

Answer: Yes.  When a generic drug product is approved, it has met rigorous standards established by the FDA with respect to identity, strength, quality, purity and potency.  Some variability can and does occur during manufacturing, for both brand-name and generic drugs.  When a drug, generic or brand name, is mass produced, very small variations in purity, size, strength and other parameters are permitted.  The FDA puts limits on how much variability in composition or performance of a drug is acceptable.

FOR MORE INFORMATION ABOUT GENERIC DRUGS

The Generic Pharmaceutical Association (GPhA)
Visit Website

The US Food and Drug Administration
Visit Website