Generic Drugs

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Information @ a Glance

  • A generic drug is a drug which is produced and distributed without patent protection.
  • A generic must contain the same active ingredients as the original formulation.
  • A generic drug is identical or bioequivalent to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
  • Generic drugs are important options that allow greater access to health care for all Americans.
  • Generic versions of a drug must use the same active ingredients as the brand name drug, and it must meet the same quality and safety standards.
  • Generic drugs are pharmaceuticals with off-patent agents, which are brought to market in the classical form with the international non-proprietary name (INN).
  • Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
  • A generic drug of biological type is different to chemical drugs because of its biological nature and it is regulated under extended set of rules for it.
  • Generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product.
  • Generic drugs are marketed under a non-proprietary or approved name rather than a proprietary or brand name.
  • Generic drugs are frequently as effective as, but much cheaper than, brand-name drugs.
  • Brand-name drug companies have used a number of strategies to extend the period of market exclusivity on their drugs, and prevent generic competition.
  • Generic drugs are identical or within an acceptable bioequivalent range to the brand-name counterpart with respect to pharmacokinetic and pharmacodynamic properties.
  • Generic drugs can reduce healthcare costs through multiple pathways.
  • Generic drugs cost much less than their branded counterpart, so the high rate of generic prescribing resulted in billions of dollars of savings for the U.S. health care system.

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