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All About Generics
The generic drug market heats up with the biggest introduction in four years. Simvastatin, the FDA-approved generic equivalent for Zocor®, became available earlier this summer. Simvastatin is a safe and effective alternative for many patients with high cholesterol, and because its a generic medication, it costs less than the brand name Zocor. If you are currently taking a brand name cholesterol medication, ask your doctor if you may be able to use simvastatin. This new generic cholesterol drug may help you save money Generic drugs — safe, equivalent, effective, affordable. | | Why pay more when you can pay less for the exact same quality? Generic drugs are identical to brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use (FDA, August 2004). Generic products meet rigorous FDA quality standards, perform the same as their brand name reference products and save consumers like you an estimated $8 to $10 billion each year.
What is a generic drug?
A generic drug is made and sold under its chemical (or generic) name by a company other than the developer or original patent holder. However, the generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance and intended use.
Are they safe?
Yes. The 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.
Do they work as well?
Yes. The FDA requires generic drugs to have the same quality, strength, purity and stability as brand name drugs. In addition, generic drugs work in the same way and in the same amount of time as brand name drugs.
Why don't they look the same?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand name drug. A generic drug must, however, duplicate the active ingredient. Colors, flavors and certain other inactive ingredients may be different.
Why are generics less expensive?
Generic drugs are less expensive because generic manufacturers don't have the investment costs of the original developer of a new drug. New drugs are developed under patent protection. The patent protects the research, development, marketing and promotion by giving the original developer the sole right to sell the drug while the patent 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.
Do all drugs have an available generic?
No. Brand name drugs are generally given patent protection for 20 years from the date of submission of the patent, and some drugs are still protected by patents and sold only by the original developer. This provides protection for the original developer to recover the research, development and marketing expenses to develop the new drug and to make a profit. 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.
Where can I learn more?
Contact your physician, pharmacists or HealthPartners for information on your generic drugs, or visit the
FDA website.
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