Understanding the Difference Between Generic Drugs and Brand Name Drugs

It costs quite a bit of time and money to develop a new drug. As a matter of fact, it can take up to
15 years to develop a new drug. Because of this, companies are allowed to receive a patent for
the drug. This patent protects the manufacturers of the drug from having another company copy
their drug. The patent, however, is only good for so many years. Once the patent expires, other
companies are free to copy and produce their own version of the drug. These copies are called the
generic form of the drug.

The original company that made the drug spent the money on advertising, etc. to get the word
out about the drug that it created. We all know how expensive advertising costs can be. Once the
patent expires, the population is already aware of the drug. So when companies begin to make
copies (generic forms of the drug), they don't need to spend any money on advertising. That
makes the price of the generic drug 30%-80% less than the cost of the brand name drug. That
means a $100 brand name bottle could cost only $20 in it's generic form.

These generic drugs are often identical to their brand name counterparts. That makes the generic
version just as effective as the original version. Generic drugs are also strictly regulated. So when
you get a generic drug from your pharmacist you can rest assured that you are still receiving the
best medical care that is proven both safe and effective.

• Generic drugs are cheaper because they don't have to pay advertising costs.
• Generic drugs are regulated, and have the same strength as brand name drugs.
• Most insurance companies authorize generic drugs before approving brand name drugs.

When I first started out in the pharmacy business I was told one thing that would change my
outlooks on generic drugs. The issue was brand vs. generic Coumadin. Coumadin is the brand
name, a drug that has been around for decades, and the generic is warfarin sodium. Whenever
the issue of

brand vs. generic debate comes into play, this is the first drug I think of. Why is it so important on
that outlook?

Prescribing Coumadin itself is an entirely different science. The skills needed to properly use the
correct milligrams is very specialized, and not for the meek or unsure cardiologist. It is an anti-
coagulant drug, meaning in laymen's terms "a blood thinner." Imagine your doctor prescribing too
much of the drug and causing your blood to become too thin, a cut can be devastating. If the
doctor does not provide a high enough dosage, a blood clot could be inevitable. This is not a drug
to mess around with. Not for humans, or for rats. It was a popular poisonous agent used to kill rats
for a long while. Now it is saving people's lives. Patients must be extremly aware of their dosing
schedule and keep up with it. If not, the results could be tragic.
In 1997 the generic form of coumadin was approved. Three companies provided their own genric,
claiming it was completely safe. Studies done in 1970's and 1980's claimed otherwise. They said
that generics could change the anti-coagulation. Grant you, these studies were done before the
FDA generic approval in 1997, but still to this done these rest results raise cause for concern.

In human terms, what is a generic drug, and how does the FDA say it's alright?

First, the drug has to have exactly the same dosage, intended use, and side effects. The generic
cannot claim to do more than the brand. Generics are always cheaper than brand because the
manufacturer does not have to spend the time nor money on developing a new drug. When
numerous companies apply for an allowance to make a generic, this drives the cost down even
more. Companies such as Watson, Wyeth, Ivax and Geneva-Sandova are four of the biggest
generic makers out there.
Are Generic Drugs Equivalent to Brand Name Drugs?
Many people still question the quality of generic medications. Perhaps people believe that
generics are inferior because the generic version of a shampoo or a laundry detergent that they
purchsed

was inferior. Confusion exists regarding the potency and quality of generic medications compared
to brand name drugs. According to the US Food and Drug Administration (FDA), a “generic drug is
a copy that is identical to a brand name drug in dosage, safety, strength, how it is taken, quality,
performance, and intended use.” The only difference is the lower cost. It is estimated that eight to
ten billion dollars per year is saved by the consumer though the use of generic medications.
Billions more are saved when hospitals use the generic form. The definition of an identical generic
to a brand name is reassuring to the consumer. However, the myth of an inferior quality in
relation to generic drugs persists. An examination of the facts should alleviate this concern. What
is a generic drug? A generic drug by definition is “bioequivalent and therapeutically equivalent
to its brand name counterparts,” says Gary Buehler, director of FDA’s office of Generic Drugs.
Bioequivalent means that the drug performs in the same manner. Because generics have the
same active ingredients, they also have the same risks and benefits. Testing standards for a
generic drugOne way to test a generic is to measure the time it takes the generic drug to reach
the bloodstream. This is the rate of absorption (bioavailability). The generic drug by FDA
standards must deliver the same amount of active ingredients into the blood stream in the same
amount of time as the brand name. Bioequivalence is the standard measurement for approving
generic drugs. This standard was established in 1984 with the Drug Price Competition and Patent
Term Restoration Act also known as the Hatch-Waxman Act. It is reassuring to note that
production of generic and brand name medications must meet standards of good manufacturing
process. The generic manufacturing facilities must be comparable to those of brand name
facilities. About 50% of the brand name firms manufacture a generic drug. These companies make
a generic for their own brand name drug but sell them without the brand’s label. The FDA requires
the manufacturer of the generic form to assure that the finished product meets certain
specifications regarding sterility. The company must prove that the generic maintains its stability
meaning that the container will not affect the drug. Each step of the manufacturing process must
document the chemistry and quality control measures that meet FDA standards. The FDA
regulates not only the drug but also its labeling. It periodically inspects manufacturing plants and
continually monitors drug quality after approval. Why do generic drugs cost less?Since a
generic drug is not made from scratch, it costs are reduced. A new brand name drug is developed
under patent protection. This is quite costly. The patent allows the drug company to recoup
money spent in development including marketing, research, and promotion for as long as the
patent is in effect which is approximately seventeen years. The patent protects the company and
does not permit other companies to manufacture the medication. When the patent expires, other
corporations can begin to use the active ingredients to manufacture the generic version of the
drug. FDA requires the generic drug to be approved. Once the generic is approved, there is more
competition and the price goes down. Why do the generic and the brand name drugs look
different? A generic drug looks different from a brand name drug because US trademark laws do
not permit generics to look exactly like the brand name. The active ingredients in a generic must
be the same. However, colors, flavors, and other inactive ingredients may be different. These do
not affect the manner in which the drug works only how the drug looks. In conclusion, generic
drugs are equivalent to its brand name drug in dosage, safety, strength, how it is taken, quality,
performance, and intended use. The difference is you will save money by purchasing the generic
form. Generic drugs not only save you money but encourage the drug manufacturing companies
to continue research for newer and better medications that have the patent protection. As always,
consult your physician regarding the medication you take.

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Generic Drugs - Benefits and Drawbacks

Your doctor has prescribed a well-known drug but hesitates over the prescription pad, or you're
standing in the aisle of your local pharmacy. You're faced with an important choice - generic or
name-brand? But what is generic, anyway? Are generic drugs safe or just cheap? Here are some

benefits and drawbacks of generic medications: Generic Defined Accounting for over 50 percent
of all drug sales in the United States, generic drugs are the same as brand-name drugs in safety,
quality, strength and purpose. The FDA requires generic drugs to be as strong and stable as their
brand-name counterparts. Though they are not allowed to look exactly like the brand-name drugs,
generic medicines do have the same active ingredients. Generic medicines become available
when the patents on their brand-name counterparts expire, usually after 17 years. The Benefits -
Affordability and Assurance The main benefit of generic medicine can be felt in your
pocketbook. Brand-name drugs cost more because their prices reflect the drug companies'
attempts to recoup the costs of research, development, testing and expensive marketing and
advertising campaigns. Once generic medicines go on the market, they ride on the reputation of
their brand-name counterparts, requiring much less overhead to produce and advertise and
passing the savings along to the consumer. Plus, more availability of a drug drives prices down
and keeps them low. And the benefits don't stop there. Each FDA-approved generic drug is
required to be as effective and contain the same active ingredients of its brand-name counterpart.
This assurance lets you know that you're not wasting your money on an alternative that is merely
cheap, but that isn't as effective or safe as name-brand. The Drawbacks - Availability and
Ambiguity If you're looking for a generic version of every medication, you might be out of luck.
Long patent terms mean that every drug does not yet have a generic counterpart. Consumer
demand does play a role, but you might get caught waiting for a generic drug that won't get
approved for the general market for years. In addition, though the safety of generic drugs is
undisputed, their absorption may vary from brand-name drugs due to different non-active
ingredients. Though generic drugs are required to have the same active elements, the form in
which that active drug is delivered may vary in generic drugs, affecting the absorption time,
although not necessarily the effectiveness, of the generic. In summary, generic drugs are a good
alternative to brand-name medications, but may not be readily available and may vary slightly
from their mainstream counterparts. Still, there's a reason that over half of the prescriptions in the
United States are for generic medications - they are proven to be safe and effective, and lower
prices make for happy - and healthy - consumers.