• What are generic drugs?
• Why are generic drugs less expensive?
• Are generic drugs as safe as brand-name drugs?
• Are generic drugs as strong as brand-name drugs?
• Do generic drugs take longer to work in the body?
• Are brand name drugs and their generic equivalents absorbed and used in the body the same way?
• Are brand-name drugs made in more modern facilities than generic drugs?
• If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
• Does every brand-name drug have a generic counterpart?
• What is the best source of information about generic drugs?
• Are generic drugs made by legitimate drug companies?
• Do all drugs have a generic available?
• Why the 17-year exclusive patent?
• Once the 17 years is up, will there automatically be a generic?
• How do I find out if the drug I take is available in a generic?

Generic Drugs Save You Money

Generic drugs help save you money, but did you know that, overall, the use of generic drugs helps to bring down the cost of medical insurance and benefits for everyone? The Congressional Budget Office (CBO) estimates that the use of generic drug equivalents in the United States saved consumers an estimated $8-10 billion in 1994?

• U.S. Generic Drugs Cost Less Than Canadian Drugs (July/2004)

What are generic drugs?

A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.

Why are generic drugs less expensive?

Generic drugs are less expensive because generic manufacturers don’t have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment—including research, development, marketing, and promotion—by giving the company the sole right to sell the drug while it is in effect. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Because those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition, which keeps the price down. Today, almost half of all prescriptions are filled with generic drugs.

Are generic drugs as safe as brand-name drugs?

Yes. FDA requires that all drugs be safe and effective. Since generics use the same active ingredients and are shown to work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs to have the same quality, strength, purity and stability as brand-name drugs.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Are brand name drugs and their generic equivalents absorbed and used in the body the same way?

Overall, yes. However, concerns have been expressed about some brand name drugs that require very close monitoring of blood levels or outcome being switched to the generic form in the middle of therapy. These types of drugs include anticonvulsants, blood thinners, asthma drugs, and thyroid drugs, among others. The FDA has investigated these concerns and, to date, no problems have been attributed to the substitution of a generic product for a brand name product (or vice versa). Even so, if you plan to switch to a generic form of these types of drugs, please be sure to double-check with your doctor first.

Are brand-name drugs made in more modern facilities than generic drugs?

No. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. FDA won’t permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.

If brand-name drugs and generic drugs have the same active ingredients, why do they look different?

In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.

Does every brand-name drug have a generic counterpart?

No. Brand-name drugs are generally given patent protection for 20 years from the date of submission of the patent. This provides protection for the innovator who laid out the initial costs (including research, development, and marketing expenses) to develop the new drug. However, when the patent expires, other drug companies can introduce competitive generic versions, but only after they have been thoroughly tested by the manufacturer and approved by the FDA.

What is the best source of information about generic drugs?

Contact your physician, pharmacist, or insurance company for information on your generic drugs. You can also visit the FDA website athttp://www.fda.gov/cder/ogd/index.htm for more information.

Are generic drugs made by legitimate drug companies?

Yes, the manufacturers of generic drugs are legitimate companies, and meet the same state and federal regulations as brand name drug manufacturers. The generic drug company may be entirely independent of the originator of the drug. However, the generic drug company may be, and often is, a wholly owned subsidiary of the originator of the brand name
drug.

Do all drugs have a generic available?

No. Many drugs do have a generic available, but the newest drugs approved by the FDA do not. Patents on new drugs expire after 17 years, at which point any company can manufacture a generic version, providing they get permission from the FDA.

Why the 17-year exclusive patent?

Before any new drug is approved, the FDA requires many years of research and testing to make sure that the new drug works, and that it is safe. Many new drugs fail to win FDA approval. For these reasons, every new drug that is approved has taken years to develop and cost millions of dollars in research and testing. The 17-year exclusive patent allows the originator to recoup their expenses, and make a profit. This provides them with the incentive to develop more new drugs in the future.

Once the 17 years is up, will there automatically be a generic?

No, because:

• Sometimes the FDA extends the patent if the originator somehow changes the formulation or the manufacturing process.
• The generic drug still must receive FDA approval before it can be sold.
• The brand name drug may be too technically difficult to make, or unique in some way. For these reasons even though it has been on the market for longer than 17 years, a generic may not be available. An example of this is the estrogen hormone replacement drug called Premarin.

How do I find out if the drug I take is available in a generic?

To find out if your drug has a generic equivalent, just type the name of your drug into a Prescription Point search box. If a generic is available, its name and price will appear in the price list, near the name and price of the brand name drug.