A generic drug is identical -- or bioequivalent -- to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
According to Medco’s (our prescription plan provider) 2011 Drug Trend Report, more than $50 billion in U.S. brand drugs, accounting for about 20% of current plan drug spending, will open to generic competition from late 2011 through 2013, creating unprecedented savings opportunities for members.
The Food & Drug Administration website, http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers, explains that not every brand-name drug has a generic drug. When new drugs are first made they have drug patents. Most drug patents are protected for 20 years. The patent, which protects the company that made the drug first, doesn't allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling a generic version of the drug. However, first, they must test the drug and the FDA must approve it.
Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less; therefore, generic drugs are usually less expensive than brand-name drugs. But, generic drug makers must show that their product performs in the same way as the brand-name drug.
To gain FDA approval, a generic drug must:
--contain the same active ingredients as the innovator drug (inactive ingredients may vary)
--be identical in strength, dosage form, and route of administration
--have the same use indications
--meet the same batch requirements for identity, strength, purity, and quality
--be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products
To find out if there is a generic equivalent for a brand-name drug, use Drugs@FDA on the www.fda.gov website, a catalog of FDA-approved drug products, as well as drug labeling.
You can also search for generic equivalents by using the "Electronic Orange Book" on the FDA site, http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Search by proprietary "brand" name," then search again by using the active ingredient name. If other manufacturers are listed besides the "brand name" manufacturer when searching by the "active ingredient," they are the generic product manufacturers. Since there is a lag time after generic products are approved and they appear in the "Orange Book," you should also consult the most recent monthly approvals for "First Time Generic Drug Approvals" under the topic of Drugs, then Information for Consumers.
Cindi Dinger, on behalf of the Wellness Committee