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Look below for answers to some commonly asked questions about generic medications.
What are generic medications?
To understand generic drugs, you need to understand a little about how pharmaceutical companies develop brand-name drugs.
A pharmaceutical company will spend many years researching and developing a new drug. When the company is ready, they begin the approval process for the new drug with the federal Food and Drug Administration (FDA). The pharmaceutical company comes up with two names for the drug. The brand name is the name that the company will use to market the drug. An example of a well-known brand name is Valium®. In most cases, the brand name is a registered trademark and can only be used by the pharmaceutical company. On the other hand, the generic name describes the active chemical ingredient of the product. This name must be approved by an independent naming council and is available for anyone to use.
Also, before the pharmaceutical company starts to sell the drug, it receives one or more patents (exclusive rights) for the drug. This means that for a specific period of time only this company can manufacture the patented drug.
However, when that specific time period comes to an end, other companies can begin to make their versions of the drug. These companies can sell their versions under the medication's generic name or a different brand name. These other versions are the "generic equivalent drugs" referred to in this article.
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Are generics really good quality products, safe and effective?
Yes. The U.S. Food and Federal Drug Administration (FDA) must approve all generic versions of a drug and assures that they meet strict standards of quality, strength and purity. In addition, the manufacturer must prove that the generic drug can be expected to produce an effect that is the same as the brand-name drug and generic drugs, like brand-name drugs, must be manufactured according to federal standards.
Same FDA requirements for brand-name and generic drugs
| FDA Requirement |
Brand -Name Drug |
Generic Drug |
| For reformulations of a drug or generic versions of a drug, FDA reviews data showing the drug
is bioequivalent to the one used in the original safety and efficacy testing. |
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| FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed. |
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| FDA reviews the active and inactive ingredients used in the formula before the drug is marketed. |
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| FDA reviews tests of the active ingredient or ingredients. |
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| FDA reviews tests of the actual drug product. |
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| FDA reviews the drug's labeling. |
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| Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug. |
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| Manufacturer must report adverse reactions and serious adverse health effects to the FDA. |
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| FDA periodically inspects manufacturing plants. |
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| FDA monitors drug quality after approval. |
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How do generics differ from their brand-name equivalent?
The main difference between a generic equivalent and its brand drug is the cost of the product.
Generics may contain different inactive ingredients, such as fillers and dyes. Inactive ingredients can give a drug its color and size. Also, a generic drug can have a different shape from its brand-name equivalent. These differences affect how the drug looks and do not affect the effectiveness of the drug. However, a small number of people may react to these inactive ingredients. Be sure to check with your doctor or pharmacist about any possible side effects that you may experience.
Even though generics may differ in color, size, or shape, they must contain the same active ingredients as the original brand-name drug. They must also be equivalent in strength and dosage and be expected to produce the same effect in the body as the original brand-name drug.
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Do all brand-name drugs have a generic form available?
Not all do. But enough generic drugs are available to account for nearly half of all prescriptions filled.
Equivalent generic products for brand name medications become available after a patent and other exclusivity rights for the brand expire. When pharmaceutical manufacturers invent and market new drugs, they get patent protection so for a period of time, only their brand of that drug is available. After patents and exclusivities expire, many other manufacturers can sell that same medication as a generic drug.
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How can I get the generic-equivalent drug?
Ask your doctor whether there is a generic form of the prescribed drug available and whether it would be right for you. If so, ask your doctor to write the prescription for the generic form or to mark on the prescription form that the pharmacist may substitute the generic for the brand-name drug.
Your health plan may ask your pharmacist to contact your doctor about generic drugs for you. For example, if you are using Medco By Mail, a Medco pharmacist may call your doctor to ask if it is all right to fill your prescription with a generic equivalent of your drug. If your doctor agrees to the change, we will fill your prescription with the generic drug and notify you of the change. Your retail pharmacist may also speak to your doctor about substituting generics.
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Why do generics cost less?
The main reason that generic drugs cost less is that the manufacturers of generic drugs do not need to pay for expensive research and development. Therefore, they can offer the equivalent drug for less.
Can using generics save my plan or employer money?
Because the generic equivalent drugs cost less than brand-name drugs, you get the same benefits at a lower cost. By using generics whenever possible, you may reduce prescription drug costs to you, your plan, or your employer. Keeping costs down helps your plan make sure they can continue to offer an affordable benefit today and in the years ahead.
Does a generic drug look different than its brand-name equivalent?
It may be a different size, color and shape from the brand-name version.
Why would I want to choose a generic drug over a brand-name drug?
By choosing a generic equivalent, you can save a significant amount of money and you won't compromise on quality. Generic equivalent medications typically cost 30-60% less than their brand-name counterparts.
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Why do generic equivalents cost less?
Several different manufacturers may develop generic equivalents. This competition results in the lower cost of generics in the marketplace.
Brand name drugs tend to be more expensive than generic drugs because the manufacturers of those brand name drugs need to recover the original research and investment associated with developing that brand name product.
When should I not take a generic drug?
Sometimes it is important to stay with the drug you're using, whether it's the generic or the brand name. You should always discuss any medication changes with your doctor.
What about side effects?
Under the FDA's regulations, a generic drug must always be made with the same active ingredients as its brand-name counterpart. But that doesn't necessarily mean that a generic drug will be identical in every aspect to its brand-name equivalent. Because of the differences in inactive ingredients, rarely, you may have a reaction to your new medication. In most cases, however, your body will not react any differently. You and your doctor should make the final decision about what's best for your health and medical treatment.
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