According to the Generic Pharmaceutical Association, generic medications account for 69 percent of all prescription medications dispensed in the United States, but only 16 percent of all the money spent on medications. Generic medications---the low-cost alternative to the more expensive brand-name drugs---allow for greater medication access by Americans. Approved by the U.S. Food and Drug Administration, generic medications are a safe, effective and low-cost alternative to brand-name drugs.
What are Generics?
Simply put, generic medications are "copies" of FDA-approved and marketed drugs whose patents have expired. They are considered bioequivalents of brand name drugs in that they have the same active ingredients, as well as dosage form, safety profile, strength, quality, route of administration and intended use, according to the FDA. They are offered at lower prices because bringing the drug to market costs considerably less. However, generic drug developers must wait 20 years for the patent on the original drug to expire before beginning development on the generic version.
Benefits
The greatest benefit generic drugs offer to patients are in the cost savings---anywhere from 20 to 80 percent---as compared to brand name versions, according to the U.S. Food and Drug Administration. An audit found that a typical formulary or list of medications offered generics for $6, preferred brand names for $29 and non-preferred brand names for $40, according to the FDA. Along with savings, generics are endorsed by the American Medical Association and approved by the FDA. An evaluation of 38 clinical trials comparing generic and brand name cardiovascular drugs found no evidence that brand-name drugs worked better, according to a paper published in the December 2008 issue of the Journal of the American Medical Association.
Differences
Generic medications are required to contain the same active ingredients as their brand-name counterparts. Requiring the same active ingredients ensures safety and that the drug performs the same in the body. Differences occur in the drugs inactive ingredients--in part due to patent restrictions that prevent identical-looking drugs from being developed. Having different inactive ingredients allows for differences in color, shape and flavor, according to the FDA.
Approval
The birth of generic medications can be traced back to the Drug Price Competition and Patent Term Restoration Act of 1984. By submitting an ANDA---abbreviated new drug application---to the FDA, would-be generic developers could significantly decrease the time it took to get a drug to market. This is because an ANDA application allowed the drug maker to skip very costly research on ingredients and dosage forms, as they were already approved by the FDA for brand-name drugs. The generic drug must also pass stringent safety and effectiveness tests by the FDA before gaining approval to market.
How to Find
A doctor, pharmacist or the FDA website can identify which generic medications are available. A full catalog of approved drugs is available through the "drugs@FDA" link on the FDA website. The Electronic Orange Book contains information on therapeutic equivalents of brand name drugs and new generic approvals are found by searching the monthly report of ANDA new drug approvals on the FDA website.
