Generic Prescriptions

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Generic PrescriptionsGeneric prescriptions work and provides benefits the same as its brand-name version.  It’s the same as a brand-name medicine in dosage, safety, effectiveness, and quality, as well as the possible side effects.  The FDA conducts a rigorous review to ensure generic medicines meet the requirements in order to receive FDA approval, such as:

  • The active ingredient in the generic medicine is the same as in the brand-name drug.
  • The generic medicine has the same strength, use indications, form (such as a pill or an injection), and form of administration (such as oral or topical).
  • The inactive ingredients of the generic medicine are acceptable.
  • The generic medicine is manufactured under the same strict standards as the brand-name medicine.
  • The container in which the medicine will be distributed is appropriate, and the label is the same as the brand-name medicine’s.
Approved generic medicines are usually only sold after patents and other protective rights to the brand-name version have ended.  New brand-name drugs are usually protected by patents, which keep others from selling generic versions of the drug. Sometimes a period of market exclusivity for a brand-name drug can affect the approval of a generic version.  Once the patents and marketing exclusivities expire, the generic drug can receive the FDA approval to be sold.

Generic medicines tend to cost less than brand-names because they do not have to repeat the studies that are required of the brand-name medicines to prove safety and effectiveness. Also, multiple applications for generic drugs are often approved for a single product; creating competition in the marketplace, and lowering prices.