In the U.S., generic drugs account for 78% of all dispensed prescriptions, up from 57% in 2004.
Although the U.S. Food and Drug Administration (FDA) has the same strict quality standards for generic and brand medications, misperceptions about the safety and effectiveness of generic drugs persist.
People need high quality, affordable medicine, which is why we've developed a list of frequently asked questions to help you better understand the value and reliability of generics.
A: This is from Staging act from DEV. According to the FDA, generic drugs are equivalent to brand drugs in terms of dosage, safety, strength, quality, the way they work and the way they're taken. Generics provide the same therapeutic benefits as brand drugs but cost less.
A: Yes. The FDA requires generics to be "bioequivalent," meaning equal in quality, strength and the way they work to the brand drug. Since generics use the same active ingredients and work the same way in the body as the brand, they have the same risks and benefits.
A: Generic drugs cost less than brand drugs for a number of reasons:
Learn more about the cost savings associated with taking generics.
A: In the U.S., a generic costs, on average, 80-85% less than the brand drug. There are a number of factors that may contribute to the cost of a medication, such as the pharmacy you go to or your insurance coverage. It is best to talk to your doctor or pharmacist to learn about the cost savings associated with taking an equivalent generic. Read Act Now, Start Talking to help get the conversation started.
A: The FDA approves new generic medications nearly every day. Click here to view the latest first-time generic drugs coming to a pharmacy near you.
A: The FDA requires generic drug applicants to scientifically demonstrate that their product is "bioequivalent," meaning that it performs in the same way as the brand name drug. Bioequivalence is demonstrated by showing that the generic medication delivers the same amount of active ingredients into a patient's bloodstream in the same amount of time as the brand drug. One way to show bioequivalence is to take blood samples after the subject is given the brand and then again after the subject takes the generic or vice versa to confirm the generic drug level is comparable to the brand.
According to the FDA, since the effectiveness of the brand drug has already been established, it is scientifically unnecessary to require that extensive testing be repeated in human subjects for each drug.
A: The FDA approves generic drugs through an Abbreviated New Drug Application (ANDA) process that requires a generic drug maker to show that its medication is identical in quality, strength and the way it works to the brand drug. This "sameness" is referred to as bioequivalence.
A: No. Brand drugs are developed under patent protection that can last approximately 20 years. In most cases, generic drug companies apply to the FDA to sell a generic after the brand drug's patent(s) expire. Ask your doctor or pharmacist if generics of your brand prescriptions are available. Here is a list of the newest generic medications approved by the FDA.
A: You may be able to determine the company that manufactures your generic medication by looking at the label on your prescription drug, reading the medication package insert or by asking your pharmacist.
A: When using any medication it's very important to carefully read the prescription drug label. Here’s a color-coded guide to help you identify certain information contained on a typical drug label that a pharmacy puts on your medication. Note, the information provided on the drug label may differ depending on the pharmacy you go to or by the state you reside in. Consult your pharmacist or doctor if you have questions about how to read the label on your prescription drug package.
A: According to the FDA, an API is the component of a drug responsible for the medication's effect. Generics are required by the FDA to contain the same APIs as the brand drug.
A: Inactive ingredients, such as fillers and colorants, can give a drug its color, size and shape. Generics must contain the same active ingredients as brand drugs but do not have to be made with the same inactive ingredients as these do not impact the therapeutic effect of the drug.
A: Drug products have many different names: chemical, generic and brand. The chemical name is typically very complex and reflects the actual physical makeup of the drug (active ingredient) itself. Generic names are based on the drug product’s chemical name and is a commonly referred to name for both the generic and brand of the drug. The brand name is created by the pharmaceutical company for marketing the medication. The brand name is typically catchy and easy-to-remember. The FDA requires brand and generic drug names to be different to prevent one drug from being confused for another when drugs are prescribed or dispensed.