Inside
Generics: Frequently Asked Questions
A guide to understanding the facts
about generic drugs
What is a generic medicine?
According to the 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 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 there is 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 all manufacturers (generic, brand-name, biologic) and
their facilities to adhere to specific guidelines called Good Manufacturing
Practices. 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 |