Inside Generics: Frequently Asked Questions
A guide to understanding the facts about generic drugs

What is a generic medicine?
According to the U.S. Food and Drug Administration (FDA), a generic drug is defined as a medicine that is “identical or bioequivalent to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.”

Do generic medications contain the same ingredients as brand-name medications? Are they safe?
Generic medications have the same active ingredients as brand-name prescription drugs. The FDA requires that all drugs, whether brand-name or generic, be safe and effective. Since generics use the same active ingredients and work the same way in the body, they have the same risks and benefits as their brand-name counterparts.

What is the difference between active and non-active ingredients?
Active ingredients are the chemicals that trigger the reaction and response within the body to treat and prevent symptoms and/or illness. The non-active ingredients in a medication include things like dyes and filler which don’t have a significant effect on the body.

Every single ingredient (both active and non-active) that goes into both brand and generic drugs must be approved by the FDA.

Why do generic medications look different than brand-name medications? Does this matter?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. The generic manufacturer is prohibited from using the same shape or colors due to patents that protect the brand of the drug. For example, the purple dye in Nexium’s “purple pill” cannot be replicated in the generic form. However, these cosmetic differences do not change the safety or efficacy of the generic version.

If a brand-name drug is already available, why is there sometimes a delay for the generic version?
When a medicine is first developed, the pharmaceutical company that engineers it and brings it to market first is granted patent protection for 20 years from the date the patent is issued. When the patent expires, other companies can obtain approval from the FDA to manufacture and sell that same drug under its “generic” or chemical name.

On certain occasions, the generic version of a patented drug will come onto the market before the patent expires. In these cases, the patent has been proven invalid or the generic version does not infringe upon the patent.

What steps are being taken to ensure that generic drug ingredients are safe, both nationally and internationally?
The safety and effectiveness of our medicines are Teva’s top priorities. The FDA requires that all manufacturers (generic, brand-name and biologic) and their facilities adhere to specific guidelines called current Good Manufacturing Practices (cGMP). Conducting audits of manufacturing facilities, tracking drugs throughout the shipping process and constantly refining anti-counterfeiting techniques are just some of the steps that the generic industry takes to provide patients with a product they can trust.

Are brand-name drugs made in more modern facilities than generic drugs?
Not at all. Both brand-name and generic drug facilities must meet the same standards of good manufacturing practices. Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50 percent of generic drug production.

Why are generic drugs less expensive?
Generic drugs are less expensive because generic manufacturers don't have the same up-front investment and research costs as the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment – including research, development, marketing and promotion – by giving the company the sole right to sell the drug while it is in effect. Because generic 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 market competition, which keeps the price down. Today, generic drugs account for over 65 percent of all prescription drug purchases in the United States.

Reports

• Effects of Using Generic Drugs on Medicare's Prescription Drug Spending, September 2010

• The Consequences of Requesting “Dispense as Written”, April 2011