Prescription drugs are a common part of everyday life. Information bombards consumers, from advertisements on television and in print, to billboards and sports sponsorships. Nearly every person can name at least one prescription pharmaceutical product. Confusion exists regarding the differences between brand name and generic products, and many patients question the safety and efficacy of generic drugs.
Brand Name Drugs
Brand name drugs are new products developed and tested by pharmaceutical companies and approved for use in humans by the U.S. Food and Drug Administration, or FDA. The first company to develop any drug receives a patent on the drug for 20 years. During the 20-year period, the developer, or innovator company, is the only authorized source of that drug, and the drug is only available as the branded product. For example, Pfizer is the only authorized source for Lipitor, which was developed and tested by Pfizer and approved by the FDA.
Confusion exists, however, because all branded products also have a generic name. In the case of Lipitor, the generic name is atorvastatin. Both names appear on a prescription label or in an advertisement. The generic name of the brand name product usually appears in parentheses after the brand name.
Generic Drugs
Generic drugs are products for which the patent for the brand name drug has expired, and the drug may now be manufactured and marketed by any company that wishes to do so. Generic drugs also require approval by the FDA; however, the approval process is abbreviated compared with the approval process for the original brand name drug. The FDA requires manufacturers of generic drugs to prove that products will perform the same way as their branded counterparts do in the body.
Generic drugs must contain the identical active ingredient at the same dosage as the brand name product. For example, generic equivalents to the brand name product Zocor must contain exactly the same amount of simvastatin, which is the active ingredient in Zocor. The FDA allows colors, flavors and other inactive ingredients to vary between manufacturers, which is why brand name and generic products look different. Manufacturing standards for generic products are as stringent as those for brand name drug manufacturers. Generic products are considered equivalent to their brand name counterparts.
A prescription for a generic drug does not typically have a brand name on the label. Some companies market generic products under a name different from the generic name of the drug, however. For example, Teva Pharmaceuticals USA markets a generic for Wellbutrin SR under the name Budeprion SR, whereas other companies market generic Wellbutrin SR as bupropion SR, which is the generic name of the drug. Both Budeprion SR and bupropion SR are considered generic products because neither manufacturer was the original developer or patent holder for Wellbutrin SR.
The cost of generic drugs is significantly lower compared with brand name drugs, in large part because the cost of developing the drug is lower. Generic drug manufacturers do not have to submit the same amount of efficacy evidence to the FDA for approval, thereby reducing production costs.
Advice for Patients
Although a brand name prescription and its generic equivalent have the same active ingredient, their flavor, color and other inactive ingredients may differ. Generic products look different and have different markings. Generic drugs undergo an abbreviated FDA approval process and must prove to the FDA only that the activity of the product in the body is identical to that of the brand name drug; brand name products must also prove efficacy for specific indications. Generic products are safe and effective. Patients who are confused about drug products that look different or have a different name than expected should ask a pharmacist or health care provider to verify the prescription.
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