A Closer Look At Mylan
Quality Medicine. Just More Affordable.
Mylan Pharmaceuticals plays an increasingly important role in our healthcare system by
making safe and effective prescription drugs more affordable for millions of Americans.
Last year, pharmacists filled more than 197 million prescriptions with products from Mylan,
making it the #1 US-based manufacturer of generic pharmaceutical products.
*
You benefit directly when Mylan Generics are used in place of name-brand medicines.
First, because you will be receiving a high quality medicine, and second,
because Mylan Generics are generally more affordable.† Whether you pay for your
entire prescription yourself, or if you have a co-payment, the savings can add up.
Mylan: An American Company
Founded in a small town in West Virginia, Mylan was one of the first pharmaceutical
companies in the United States to develop more affordable alternatives to name-brand
prescription drugs. Today, Mylan manufactures products for diseases ranging from
angina to arthritis, depression to diabetes, pain to Parkinson's disease, and
schizophrenia to sleep disorders, to name just a few.
A company with a reputation for quality, Mylan has pioneered the development
and production of sophisticated dosage forms such as extended-release tablets and capsules
as well as transdermal patches that deliver medication through the skin. In fact,
last year, Mylan was among the top manufacturers of transdermal patches in America.*
What Makes a Drug Generic?
Generally, new drugs are patent-protected for 20 years from the date the patent is filed.
That means that during this period, only the patent-protected product can be sold.
Most of these patent-protected drugs have two names: a chemical name that identifies
the active ingredient, and a "name-brand" that is used for advertising purposes.
For example, acetaminophen is a chemical name and Tylenol
®‡ is a
name-brand
for acetaminophen.
When the patent on a name-brand drug expires, the Food and Drug Administration (FDA)
allows certain companies that meet strict standards for manufacturing, such as Mylan,
to produce equivalent versions of the original product.
These equivalent products, which must receive FDA approval prior to marketing, are
usually sold using the chemical name that identifies the active ingredient.
For example, if Mylan were to manufacture
an alternative to Tylenol, it would be known simply as "acetaminophen."
How Mylan Generics Measure Up
Mylan Generics contain the same active chemical ingredients as their name-brand
counterparts and are identical in strength, dosage form (tablet, liquid, etc.),
and route of administration (taken by mouth, injection, etc.).
Since Mylan Generics use the same active ingredients as name-brand drugs that were
previously approved by the FDA, Mylan is not required to prove again that the active
chemical ingredient is safe and effective. This would be like requiring a new
acetaminophen manufacturer to "reprove" that acetaminophen can relieve pain.
Instead, the FDA requires Mylan to conduct tests to prove that their products supply the
same amount of the active ingredient in the body at a comparable
rate to the name-brand drug.
Quality Is Assured
The manufacturing facilities of all pharmaceutical companies—those making name-brand
drugs and those making equivalent alternatives—are routinely inspected by the FDA.
To ensure that standards are being met, FDA officials analyze countless samples
of products and make thousands of inspections each year. Every company must
demonstrate that its manufacturing processes will produce the same consistent
quality each time a product is made.
Consumers can be assured that all FDA-approved pharmaceuticals available in the United States—name-brand and
affordable alternatives such as those manufactured by Mylan—have undergone,
and continue to undergo, the strictest review.
Savings Are Significant
Mylan Generics are less expensive alternatives to name brand drugs.
† In fact, at roughly
one-third the price of brand-name medications, generics can bring consumers significant savings.
§ These savings are the result of good, old-fashioned,
American competition. As you can well appreciate, when there is more than one
company manufacturing and/or selling the same product, the competition generally
results in cost savings for the consumer. However, until the patent expires on a
name-brand drug, there is generally no competition, and therefore, little incentive
for lower prices.
The savings can be significant even if you have a prescription drug plan because
your co-payment is usually less than that for the name-brand drug. Just as important,
when an insurance company pays more for a name-brand drug, the higher cost may be passed
on in higher co-pays and increased premiums to employers... which could impact you as well.
Healthcare for the Future
Mylan Generics have been available for nearly 45 years and have touched the lives of millions of
Americans. As the need for more affordable medications grows, Mylan will continue to play a
major role in helping reduce the high cost of healthcare.
For more information about Mylan and to find out if a Mylan Generic is
available for the prescription medicine that you take, visit our website at
www.mylan.com.
* IMS National Prescription Audit. December 2004.
† Actual cost to consumers may vary.
‡ Registered trademark of The Tylenol Company.
§ U.S. Food and Drug Administration,
www.fda.gov/fdac/features/2003/503_drug.html.
©2005 Mylan Pharmaceuticals Inc.