FAQ - Generic Drugs

What are Generic Drugs?

Pharmaceutical companies spend many years researching and developing new drugs before beginning 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. The brand name is usually a registered trademark and can only be used by the pharmaceutical company. 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. As an example, Prozac is Eli Lilly's brand name for fluoxetine (the generic name). Other companies may manufacture fluoxetine, but must use the generic name or a different brand name. for example, the generic fluoxetine we sell is called Fluox.

Also, the pharmaceutical company receives one or more patents (exclusive rights) for the drug. As a result, there is 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 manufacturing 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 what are termed generic drugs, generic medications or generic equivalents.

Are Generic Medications Safe and Effective?

Yes. The U.S. Food and Federal Drug Administration (FDA) approves 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 identical effect to the brand name drugGeneric Drugs must also be manufactured according to federal standards.

The following procedures are all carried out by the FDA to ensure the quality and safety of generic Drugs:

• 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.
• FDA evaluates the manufacturer's adherence to good manufacturing practices before the drug is marketed.
• FDA reviews the active and inactive ingredients used in the formula before the drug is marketed.
• FDA reviews tests of the active ingredient or ingredients.
• FDA reviews tests of the actual drug product.
• FDA reviews the drug's labeling.
• Manufacturer must seek FDA approval before making major manufacturing changes or reformulating the drug.
• Manufacturer must report adverse reactions and serious adverse health effects to the FDA.
• FDA periodically inspects manufacturing plants.
• FDA monitors drug quality after approval.

What are the Differences Between Generic Drugs and Brand Name Drugs?

The major difference between a brand name drug and its generic equivalent is the cost of the product. The company that originally manufactures a drug will spend a lot of money on research & development and marketing. these costs are then passed on to the customer. Maufacturers of generic medications can avoid these costs.

Generics may contain different inactive ingredients from their brand name equivalents. These inactive ingredients can change the color and size of a generic drug. A generic drug may also have a different shape from its brand name equivalent. These differences are purely cosmetic and have no effect the efficiency 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.

What are the Similarities Between Generic Drugs and Brand Name Drugs?

Generic Drugs 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.

Do all Brand Name Medications Have a Generic Equivalent Available?

No. However there is a wide range of generic drugs available which to account for nearly half of all prescriptions filled.

Generic equivalents of brand name drugs become available after a patent and other exclusivity rights for the brand expire. When pharmaceutical manufacturers producr and market new drugs, they get patent protection so for a period of time. During this perod, 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.

Why do Generic Drugs Cost Less?

Manufacturers of generic drugs avoid the costs of expensive research and development. Also, they spend a lot less money on marketing and advertising. Therefore, they can offer the generic equivalent of a brand name drug for a much cheaper price.

Because generic medications can be manufactured be several companies, the increased competiton also results in lower prices.

Are There Any Side Effects of Generic Drugs?

Under the FDA's regulations, a generic drug must always be made with the same active ingredients as its brand-name counterpart. However due to possible differences in the drugs inactive ingredients, you may have a reaction to some generic medications. In most cases, your body will not react any differently. Your doctor should be able to advise you if there are likely to be complications.

Why Choose a Generic Drug Over a Brand Name Drug?

By choosing a generic equivalent, you can save a significant amount of money. Generic equivalent medications typically cost 25-70% less than their brand name counterparts. And with the strict FDA requirements, you can be sure that there is no compromise on the quality of generic drugs.