Guide Generic Drugs: A Consumer’s Self-Defense Guide

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Some drugs -- known as NTI narrow therapeutic index drugs -- may need special consideration if you are thinking of using the generic version. NTI drugs have a narrow margin between the amount that is safe and effective and the amount that is toxic. In those states, if generics are used, precautions and additional monitoring are required.

How Are Generics Different From Brand-Name Drugs?

The list of restricted NTI drugs varies from state to state. The FDA is revising its policy to identify drugs that should be included on such a list and to specify whether additional precautions are needed when generics are substituted for such drugs. Generics are not available for all medications. The best way to find out if a generic is available for a medication you are taking -- and whether or not you should take it -- is to ask your doctor and pharmacist.

Some health insurance providers require you to use a generic drug, if available. If you choose to purchase the brand-name product, you may end up paying on your own or have a larger co-pay. Generally, your pharmacist can substitute a generic drug for a brand-name drug. If your pharmacist for some reason does not substitute a generic for a brand-name drug, you can ask your doctor to indicate on the prescription that substitutions are acceptable.

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That way, you can get the same drug for a lot less money. It can get confusing. Don't be afraid to ask your pharmacist if the medication you received is the generic form of the medicine you are used to taking.

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Tell your doctor if you notice any change in your condition or have any unusual side effects when changing from a brand-name to a generic drug. And don't forget that nonprescription drugs may also be sold as generics.

Are Generic Drugs Effective?

You might find them under the store's in-house label. They can also save you money. That means the generic drug is safe and can be taken: The same way as a brand-name drug For the same reason as a brand-name drug For the FDA to approve a generic drug, it must be the same as the brand-name product in: Active ingredient Strength Use and effect How you take it for example as a pill, inhaler , or liquid Ability to reach the required level in the bloodstream at the right time and to the same extent Testing standards How Are Generics Different From Brand-Name Drugs?

Generic drugs may differ in: Shape Color Packaging Labeling minor differences Generic drugs are allowed to have different inactive ingredients than brand-name drugs. For example, they may have a different: Flavoring Preservative The inactive ingredients in a generic, though, must be considered safe by the FDA.

Generic Drugs: Answers to Common Questions

Continued Making a new drug is expensive. A manufacturer's costs for the launch of a new drug include money for: Research Large-scale drug testing Advertising, marketing, and promotion The FDA has tried to balance the rights of the maker of brand-name drugs to recoup its investment with the rights of patients to have access to lower cost generic drugs.

These generic drugs include: Your doctor should tell you if you are taking an NTI drug and what type of monitoring you need. Continued Tell your doctor if you notice any change in your condition or have any unusual side effects when changing from a brand-name to a generic drug. Patents grant the company exclusive rights to a drug for 20 years. Additional patents can sometimes be filed to extend the patent life.

Also of Interest

Usually, about 10 years elapse between the time a drug is discovered when the patent is obtained and the time the drug is approved for human use, leaving the company only about half of the patent time to exclusively market a new drug. The FDA may choose to accelerate the approval process for drugs to treat AIDS, cancer, and other life-threatening disorders when no current effective treatment exists.

After a patent has expired, other companies may produce and sell a generic version of the drug that is approved by the FDA. They typically sell their product at a lower price than the original brand-name drug because the generic manufacturer does not have to recover the original costs of drug development and usually spends much less on marketing.

A generic drug may be sold under its generic name or under a brand name a branded generic drug but not under the brand name used by the original patent-holder. Not all off-patent drugs have generic versions. Sometimes a drug is too hard to duplicate, or adequate tests are not available to prove that the generic drug acts the same as the brand-name drug. Sometimes the market for the drug is so small that producing another version does not make good business sense. Generic versions of some nonprescription over-the-counter drugs are often sold as house brands by drug chains or cooperatives, usually at a lower cost.

These drugs are evaluated in the same way that generic prescription drugs are evaluated and must meet the same requirements. Pharmacists can advise which generic over-the-counter drug products should be as effective as the original. However, a consumer may prefer one product to another because of appearance, taste, consistency, or other characteristics. Tap to switch to the Professional version. Overview of Generic Drugs and Drug Naming. Are Your Pet's Meds Legit?

How Are Generics the Same as Brand-Name Drugs?

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