FAQs

What are Generics?

For more than 25 years, America's generic pharmaceutical industry has been providing U.S. Food and Drug Administration (FDA) approved generic versions of brand medicines at a substantial savings to the consumer. Generic drugs play an important role in providing you with greater access to established drug products at affordable prices to reduce your health care costs while receiving the same quality of care. Generic drugs contain the same active ingredients, in the very same strength, as brand-name drugs. Generic drugs are well accepted for substitution of brand-name drugs as they sell at a discount to the branded product's price and have been determined to be their equivalent in quality and efficacy. They must meet the same governmental and FDA quality and effectiveness standards as the original.

Are generic drugs as good as brand-name?

Generic pharmaceutical manufacturers must prove to the FDA that their version of a drug:

contains the same active ingredient

is identical in strength, dosage form, and route of administration

has the same indications, dosing, and labeling

provides the same efficacy and safety profile to patients ("bioequivalent")

Are generic drugs safe?

Generic medicines have to be safe and effective to be approved by the FDA. The FDA also requires generic manufacturers to:

meet the same batch-to-batch requirements for strength, purity, and quality as the original manufacturer follow the same strict "Good Manufacturing Practices" rules

Why do generic drugs look different than the brand-name product?

U.S. trademark laws don't allow generic drugs to look exactly the same as another drug already on the market. For that reason, the color and shape of a generic pill may be different than the brand-name. Sometimes it will have a different coating or flavor. These "inert ingredients" also are carefully considered by the FDA. Differences in taste or appearance do not affect the drug's safety or effectiveness.

Why are generics cheaper?

Some brand-name manufacturers charge customers higher prices in the United States than they do in other countries, where drug prices are regulated. Drug research is costly, and patent protection gives brand-name manufacturers a number of years with exclusive product rights to recover those costs-costs that generic manufacturers do not have. Brand-name manufacturers collectively spend billions of dollars in marketing new drugs to doctors and the public; they send their representatives to visit with doctors in their offices; and they pay for physicians' trips to meetings and conferences to talk about their drugs with other doctors. Generic manufacturers rarely spend money on promotional activities that brand companies undertake – another important way they keep their costs down.

Is a generic drug available for my brand-name prescription?

The easiest way to find out is to simply ask your doctor or pharmacist. There are also online resources listed below.Helpful Tools:

1. A tool from Drug Digest to find out whether a generic version of your prescribed drug is available.

2. Drugs@FDA A search tool from the Food and Drug Administration to help you identify whether your brand-name drug has any "therapeutic equivalent" versions.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

3. Questions and Answers From Food and Drug Administration (FDA)
http://www.fda.gov/cder/info/consumer_generic.htm (English)
http://www.fda.gov/cder/consumerinfo/generics_q&aSpanish.htm (Spanish)

Customer Concerns and Product Issues

Phone: +1 888-212-6921

Email: wespharma_micc@mitoconbiopharma.com

• Please note, we cannot respond to questions about general medical information or questions regarding your personal medical condition. If you have questions about a specific medical condition, please consult a healthcare professional.