Explains the differences and similarities between brand name drugs and their equivalent generic drug brands.
In 2007, $228 billion dollars was spent on brand name drug products, and $58.5 billion was spent on generic drug products.
A generic drug is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its chemical name without advertising. Generic drugs are subject to the regulations of the governments of countries where they are dispensed.
Yes, there are differences.
Both drugs contain the same active ingredients (the therapeutic, medicinal portion), but the drugs contain different fillers, binders, coloring agents, and flavorings.
Generics are considered (by the FDA) identical in dose, strength, route of administration, safety, efficacy, and intended use.
The time it takes a generic drug to appear on the market varies. In the US, drug patents give twenty years of protection, but they are applied for before clinical trials begin, so the effective life of a drug patent tends to be between seven and twelve years.
For as long as a drug patent lasts, a brand name company enjoys a period of "market exclusivity" or monopoly, in which the company is able to set the price of the drug at a level which maximizes profitability. In most cases, generic products are available once the patent protections afforded to the original developer have expired. When generic drugs become available, the market competition often leads to substantially lower prices for both the original brand name product and the generic forms. Companies incur fewer costs in creating generic drugs (only the cost to manufacture, rather than the entire cost of development and testing) and are therefore able to maintain profitability at a lower price. Sometimes reverse-engineering is used to develop bio-equivalent versions to existing drugs. Generic manufacturers also do not bear the burden of proving the safety and efficacy of the drugs through clinical trials, since these trials have already been conducted by the brand name company.
To gain FDA approval, a generic drug must:
The FDA has cautioned against several classes of drugs that require special consideration when choosing equivalents. These drugs may be therapeutically equivalent; however they may have characteristics which may cause problems in bio-equivalence, such as insolubility in water and pharmacokinetic discrepancies. Specific examples include drugs with critical dose and narrow therapeutic index (warfarin, levothyroxine) characteristics, special release formulations (extended release (ER), delayed release (DR), and bio-engineered protein drugs (insulin, Enbrel).
Drug companies often change how they market or package their products. It helps to know that:
For most consumers, their insurance plan determines what they pay for medication.
Both private and government insurance companies promote using generic drugs when possible. They might even require substituting a generic for a brand name drug.
The co-pay for the generic might be $10. But the co-pay for the same dosage and amount of the brand name might be $40.
Some insurance plans might require you to pay the entire cost of the brand name drug if you don't accept the available generic.
1 - Not all medications have a generic form available.
2 - Some doctors might not be aware of recently approved generics.
3 - Different states have different laws and regulations on generic substitutions.
4 - Doctors differ in their beliefs towards, and experiences with, different medications.
If you're interested in trying a generic drug, first find out if it's available. Ask your doctor. Also, your pharmacist will have a list of generic drugs and can usually tell you how much they will cost on your insurance plan.
In some cases, it is unwise to switch from a brand name med to its generic form. There are certain drugs that have a narrow therapeutic index (NTI). With this group of drugs, if you switch to a generic form, you may compromise the availability of active drug in your system.
If you decide to buy generic, have your doctor choose a drug with an identical format as the brand name and not with merely the same active ingredient. The generic should mimic the entire original drug.