What is the difference between brand-name and generic drugs?

Differences between generic and brand-name drugs

Fast facts

• Manufacturers formulate generic drugs to work the same way and provide the same benefits as their branded counterparts.
• Once a brand-name drug’s patent has expired, a drug company can file an “abbreviated new drug application” (ANDA). This allows them to produce a generic version of the same drug.
• The generic drug must meet strict standards before the FDA will approve it.
• According to the FDA, generic drugs may cost 80–85% less than their brand-name equivalents.
• You can search the Approved Drug Products with Therapeutic Equivalence Evaluations (also called the Orange Book) for FDA-approved drugs and patent information.

Price

Typically, generic drugs cost less than their brand-name equivalents. The price can be up to 85% less, according to the FDA.

The following are reasons for this cost difference:

Research costs

Generic drugs benefit from a reduction in upfront research costs.

Brand-name drugs have to go through expensive animal and clinical studies to prove their safety and efficacy. Generic drugs use the same active ingredients that the branded drugs carried out testing for, so they do not have to conduct the same testing. This saves the drug producers money, and consumers then benefit from these savings.

Competition

When more than one company produces a generic version of the same drug, there is more competition. Lower prices generally go hand-in-hand with more competition.

If you are likely to be aware of these price differences, it may affect which medication you choose.

Appearance

Brand-name and generic drugs must contain the same active ingredient. However, characteristics of the drug not affecting the safety or efficacy may be different. This includes their appearance.

United States trademark laws do not allow generic drugs to look exactly the same as the equivalent brand-name drugs. However, the extent of these differences is regulated.

When a company wants approval to produce a generic drug, they need to file an ANDA. These are filed with the FDA’s Office of Generic Drugs (OGD). Generic drugs can have different physical characteristics than their brand-name equivalents.

Significant differences in characteristics such as size and color may:

• negatively affect your compliance with treatment
• make it difficult for you or your doctor to identify the medication
• lead to the placebo effect, where positive associations of a treatment with no therapeutic value is working
• lead to the nocebo effect, where negative associations of a treatment cause it to have a more negative effects

The OGD developed a guidance document to help generic drug manufacturers produce drugs similar in shape and size to their branded counterparts. It provides parameters from both manufacturing and safety standpoints.

Medical Perspective

“Most tablets and capsules have an imprint code (letters and/or numbers) to help identify the drug and its strength. Generics often look different from the brand-name version. You can look up imprint codes using tools like U.S. Food and Drug Administration pill identifier tools.”

— Alex Nguyen, PharmD, RPh, CP

Read about some of the most common brand-name drugs and their generic versions in the U.S. here.

_{Quotes represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.}

Approval standards

The FDA requires generic drugs to meet a number of standards before approval. These include:

• The manufacturer can produce the generic drug both correctly and consistently.
• The generic drug has the same “active ingredient” as the brand drug.
• The correct amount of the active ingredient gets to the target area in the body.
• The ”inactive ingredients” in the generic drug are safe.
• The generic drug’s bottle, box, or other container is suitable.
• The generic drug’s label is the same as the brand drug’s label.
• The generic drug does not deteriorate over time.
• The legal exclusivities or patents have expired.

The drug company must submit an ANDA. It states that the generic drug meets each standard.

Availability

If you are taking a particular drug, you may want to know if there is a cheaper generic option. There are several ways to find out if there is a generic version of a brand-name drug. These include:

• asking the prescribing doctor or pharmacist
• searching for the drug using the FDA’s Drugs@FDA system (Search the brand-name drug first.)
• searching for the drug using the online version of the Orange Book (Search the brand-name drug first.)
• checking the FDA’s list of first-time generic drug approvals. This is where people can find “first generics” — the first time the drug gets FDA approval.

Which is better: Brand or generic?

According to the OGD, all FDA-approved generic drugs must meet the same quality, purity, strength, and stability requirements as their brand-name counterparts.

During a comparison study of U.S. health insurance claims, researchers found that branded and generic drugs had comparable medical results for chronic physical conditions. The conditions they looked at included high blood pressure, diabetes, osteoporosis, and mental health conditions such as anxiety and depression.

However, another analysis found that generic drugs may not have the same clinical impact for certain heart conditions.

Researchers analyzed reports from the scientific databases MEDLINE and EMBASE. They found that while 60% of the studies reported no difference between the drugs, the risk of hospital visits was higher in people taking the generic.

It is important to note that this study merely showed a correlation. It did not show that the generic drug played a role in the increased hospital visits.

When determining the better option between brand-name and generic drugs, your healthcare professional may consider the specific health condition and current research when prescribing medication. They may also have a preference for one over the other.

Choosing brand-name or generic drugs

When choosing which drug to take, you may consider several factors.

Ultimately, it is up to you and your healthcare professional to determine the best option among the brand-name and generic drugs available.

Quality

The drug company must submit an ANDA showing that the generic drug meets each FDA-required standard before the FDA will approve it. That includes showing that the generic drug is pharmaceutically equivalent to the branded medication.

This helps you feel more confident that the generic drug option is of the same quality as the brand-name version.

Attitude and intention

Researchers have found that three main categories can form your attitude toward, and intention to purchase, generic drugs. These are:

• Consumer attitude and behavior: This is a combination of your beliefs and feelings about a product and your behavioral intention toward that product.
• Consumer views: These include a yours and your healthcare professional’s views toward generic medicine.
• Risks: This includes the risks, if any, associated with the generic drug.

The researchers state that if the pharmaceutical industry, public health policymakers, and healthcare professionals better understood consumer attitudes and behavior toward generic medicine, they could help expand generic drug use.

Summary

Brand-name and generic drugs contain the same active ingredients in the same amounts. In most cases, they provide the same therapeutic benefits. Your healthcare professional may prefer one version over the other.

Because they do not have to undergo the same human and animal studies as brand-name drugs, FDA-approved generic drugs are significantly less expensive. This price difference influences some people’s decision to choose generic drugs over brand-name drugs.

However, it is advisable to discuss both brand and generic drug options with a healthcare professional. This allows you to make the right decision for your health and personal circumstances.