What's in a (brand) name? A brand name drug is the first version of a particular drug marketed by a specific drug company. Brand name drugs are exclusive and are protected by a patent. Also known as single source agents, the exclusivity of brand name drugs helps drug manufacturers recoup research and development costs through higher prices.
What is a generic drug? An "A-rated" generic drug is a medication the FDA has determined is equivalent to the brand name product in safety and effectiveness. Only A-rated generic drugs may be substituted for brand name products in the formulary.
Do generic drugs measure up? When the patent on a specific drug expires, a generic version can be marketed at a much lower price than the brand name. To market any generic drug, the U.S. Food and Drug Administration (FDA) requires it to contain the same active ingredients in the same dosage forms and strengths as the brand name counterpart. Generic drugs must meet the following criteria when compared to their brand name counterpart:
Ability to deliver the same amount of active ingredient into the bloodstream in the same amount of time.
Identical bioavailability, which is the extent and rate at which the body absorbs the drug.
Identical bioequivalency, which means the generic is as effective as the brand name.
The FDA gives an "A" rating to all generic drugs that comply with these and other standards. This system ensures a generic medication conforms to the same standards as its brand name counterpart.
How can a consumer find out the FDA's rating of a generic drug? Brand name drug products and their therapeutically equivalent generic drug products are cataloged in the FDA publication, Approved Drug Products with Therapeutic Equivalent Evaluations, frequently called the "Orange Book" Drug products listed as therapeutic equivalents can be expected to have the same clinical effects.
What about drugs with a narrow therapeutic index? There are some drug products in which a small change in dose or blood concentration can result in a clinically important change in drug efficacy and safety. These narrow therapeutic index (NTI) drugs require frequent adjustments and careful patient monitoring regardless of whether the drug is a brand name or generic.
If brand name and generic drugs are clinically equivalent, why do some people have a reaction to a generic medication? A person who reacts to either a generic or a brand name drug is more likely to be responding to inactive ingredients rather than the active medication. If someone reacts to an active ingredient, he or she will react to both the generic and brand name medication.
What is a three-tier pharmacy benefit design? A three-tier benefit design is a prescription drug benefit with three different copay levels, based on the medication purchased. The three-tier benefit design promotes the use of formulary generic and brand name drugs by offering a lower copayment for these medications. Commonly, a three-tier benefit design looks like this:
