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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.