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All About Generic Medications


All About Generic Medications

Generic drugs are a therapeutic "copy" of brand-name drugs.

According to the Congressional Budget Office, every year, consumers save an estimated $8 billion to $10 billion dollars by using generic medications.

The FDA regulates generic medications. They are allowed on the market only after testing has proved they are equivalent to their brand-name counterparts.

Not every drug has a generic. Generally, when brand-name drugs are first developed, a patent protects them for 20 years before a generic alternative can be manufactured. It often takes the manufacturer 10 to 12 years to complete the approval process, so the patent-protected time on the market is generally about 8 to 10 years. Drug companies can apply for extensions of this patent protection period. If the patent period isn't extended, other companies can introduce their version of the brand-name product after 20 years from the original date the manufacturer identified the new drug to the FDA. 

Lower cost

Prescription medications are one of the fastest-growing areas of U.S. health care spending.

One way to reduce the high cost of prescription drugs is to switch to generic drugs, which are priced 25% to 80% lower than the equivalent brand-name versions.

One reason generic drugs cost less than their brand-name equivalents is that manufacturers of generics spend less money on advertising and product development.

Quality assured

The FDA assures doctors and patients that generic drugs provide the exact same health value as their brand-named equivalents. FDA rules state that a generic drug must be "bioequivalent" to the brand-name drug, meaning it must have the same active ingredients, strength, dosage form, safety, quality, purity, stability and performance. The generic drug also must be absorbed at the same rate. The FDA publishes The Orange Book, which lists drugs that are considered to be "equivalent."

Drug makers must adhere to strict manufacturing requirements to earn approval to sell their products. Keep in mind that generic drugs bought over the Internet from places outside the United States are not regulated by the FDA and may not meet the same standards for equivalency or safety as those sold in this country.

Differences between brand-name and generic drugs that may make a difference in how compliant a patient is in taking the medication are the size, shape, and coating. These differences do not affect the quality, effectiveness, or safety of a drug. Other differences between brand-name and generic drugs include taste and inactive ingredients.

Doctor approved

Depending on the medications you take and how often you take them, you could save hundreds of dollars every year by taking generics instead of brand-name medications.

When your health care provider gives you a prescription for a brand-name medication, ask if he or she can prescribe the generic equivalent instead. You also can ask if you can switch from brand names to generics for medications you already take.

In some cases, health care providers prefer brand names for medical or technical reasons. If so, your health care provider should be able to explain why.