Brand-name medications go through extensive clinical trials to show the safety and efficacy of treatment to receive Food and Drug Administration (FDA) approval. Once FDA-approved, the brand manufacturer has the exclusive right for market access, which may last about 10 years, depending on how long the clinical trials took to complete.

The FDA does not require generic medication manufacturers to repeat the same clinical trials. However, to meet the same FDA standards for quality, the medication must:

  • have the same amount of active ingredient(s)
  • be in the same dosage form
  • be labeled with the same dose
  • be administered the same way as the brand-name drug

If the manufacturer meets the FDA-required criteria, they can market the generic medication at a much lower price than the brand-name option due to lower overall development cost. They can then pass on the savings to consumers.

Generic drugs contain the same active ingredient(s) as the brand and work but may differ in color, size, shape, and inactive ingredients.

Both must meet the same manufacturing standards, quality assurance, safety, strength, and effectiveness of the active ingredient(s).

The FDA Generics Drug Program conducts reviews and inspections to ensure the generic manufacturing plants meet these standards and monitor drug safety after a generic is approved and marketed.

In most cases, people can easily switch from one generic drug manufacturer to another generic manufacturer or a brand-name option.

However, a few drugs require precise dosing. For example, levothyroxine or warfarin may require a person to get blood tests when switching back and forth. Slight differences in active ingredients may also occur between manufacturers, and different batches from the same brand or generic manufacturer may also vary. However, the chances of serious issues with switching are quite small.

Branded medications still covered by exclusive patents will not have a generic version available. Some off-patent medications may not have a generic available if people rarely use them, or it is difficult to duplicate the manufacturing process.

Generic drugs do not require expensive clinical trials for FDA approval, lowering the development costs.

Depending on manufacturing costs and competition from other generic manufacturers, prices can be as much as 80–85% less than the brand-name drug.

Medicare Part D Plans may cover brand-name drugs when no generic is available. The copayment may be very expensive if a person needs a brand-name drug.

Dr. Alan Carter is a clinical pharmacist with interests in medical research, pharmacy practice, and medication formulary management. He is an independent contracted medical director for pharmaceutical development, clinical pharmacy specialist, and adjunct clinical assistant professor of pharmacy.