Are generics really the same as brand-name medications?

While you may not recognize the name, most generic drugs are developed by brand-name manufacturers. After a patent expires on a company's brand drug, the company often manufactures essentially the exact same drug and sells it as a generic for much less.

Trademark laws prohibit generic drugs from looking exactly like their brand counterparts; however, while aspects like color and flavor may be slightly different, the drugs must have the exact same active ingredients.

Are generic medications as well-regulated as brands?

FDA-approved generic drugs meet the same rigid standards as brand-name drugs. To gain FDA approval, a generic drug must:

• Contain the same active ingredients as the original, brand-name medication
• Be identical in strength, dosage, and method in which it's taken
• Have the same use indications
• Perform in the same manner (be bioequivalent)
• Meet the same batch requirements for identity, strength, purity and quality
• Be manufactured under the same strict standards of FDA's good manufacturing practice regulations required for innovator products

Generic drugs are a safe, effective alternative to brand-name prescriptions, while also being 30-80% cheaper. From quality and performance to manufacturing and labeling, each aspect must meet the FDA's high standards. With such strict regulations, one can feel confident about the quality of one's generic drugs.

How do I safely and effectively save money by switching to generic drugs?

Always ask your doctor: Is there a generic or an over-the-counter alternative for this drug?
If a generic equivalent is not available: Is there another generic in the same class that would be just as effective for my condition?

If there currently is no suitable generic, always check the "May Substitute" box. That way if one becomes available later, you can receive generic refills without asking your doctor to write a new prescription.

Periodically visit the U.S. Food and Drug Administration’s website (www.fda.gov) to see if your brand-name drug has become generically available. You can look up the drug name or the active ingredient. If a generic has been approved, the next time you get a refill ask your pharmacist to substitute the generic equivalent. Even if your doctor previously checked the "May Not Substitute" box, your pharmacist can call your physician to see if a substitution can be made.

Are generics widely used?

Generics already account for over 60% of prescriptions in the country and that number is rapidly increasing. Many patents are expiring on drugs introduced in the late 80s and early 90s, an especially productive era of pharmaceutical research and development, allowing increased introduction of generic alternatives. Private employers and pharmacy benefit managers have encouraged the trend with tiered co-pays, allowing consumers to pay less by choosing the cheaper generic alternative, and pay more for the more expensive name brands. Medicare is also using incentives to encourage the use of generics in its Part D Drug Plan.

How can generic drugs be so much cheaper?

Generic drugs are less expensive because generic manufacturers don't have the investment costs that come with developing 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. As patents near expiration, manufacturers can apply to the FDA to sell generic versions. Without the same development costs, they can sell their product at substantial discounts. Also, once generic drugs are approved, there is greater competition and that keeps the prices down.

Why are prescription drugs so expensive?

Americans pay more for prescription drugs than citizens of any other country. Prescription drug prices have risen partly because of the increasingly competitive environment. Drug companies can get multiple patents and extensions to protect themselves from competition and thus are able to charge more. This funding is needed as research and development of new drugs is a very lengthy and expensive process. In addition, millions are spent each year on marketing and education as drug companies no longer focus on just winning over physicians, but now also encourage consumers to ask for drugs by name when they visit their doctor's office.

What about "free sample" medications?

"Free samples" are a marketing tool used by drug companies to start patients on more expensive brand-name drugs. Using a sample does not obligate you to fill a prescription for that drug, so after you have tried a sample, be sure to ask your doctor whether a generic equivalent could be used to treat your condition. A "free sample" can actually cost you a lot of money. Take a look at the example below:

The next time you consider filling a prescription with a brand drug (preferred or non-preferred) you received as a sample, ask your doctor about a generic alternative. Regardless of what you select, do not commit to more than a 30-day until you are sure it works for you.