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
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
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
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
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
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.
of Using Generic Drugs on Medicare's Prescription Drug Spending, September
Consequences of Requesting “Dispense as Written”, April 2011