What you should know about brand-name and generic medications

This post was written by Haley Michaud, PharmD, Parkview Health.

When choosing medications, patients typically encounter brand-name and generic medications. While both types are designed to effectively treat medical conditions, understanding their subtle differences can help you make more informed decisions about your health. Below we cover the approval process for these medications and discuss how this affects your treatment options.

FDA drug development process

The Food and Drug Administration (FDA) protects the public health by ensuring that all drugs, biological products, and medical devices available in the United States are safe and effective. Before a new drug comes onto the market, drug manufacturers must submit applications to the FDA for review and approval. This process is rigorous and involves several steps including:

Discovery and development

Preclinical research

• Laboratory and animal tests are being conducted to determine whether the drug has the potential to cause serious harm.

• After successful testing, an Investigational New Drug (IND) application is submitted.

Clinical research

FDA review

The manufacturer submits a New Drug Application (NDA) and the FDA reviews the data to decide whether to approve or reject the drug. If the drug is approved, the FDA will conduct postmarketing safety surveillance that includes:

• Monitoring of adverse reaction cases through FDA MedWatch.

• Conduct routine inspections of drug manufacturing facilities.

• Regulating drug advertising and labeling to ensure that it does not encourage unauthorized use of the products.

Brand name

Branded medications are original medications that have been developed and researched to treat a specific condition. They are also called “innovator” or “originator” drugs. These drugs are protected by patents that prevent manufacturers from selling or manufacturing them for a certain period of time, usually a decade or longer.

The patent grants the company exclusivity to market the drug at its own price and helps it cover some of the costs associated with researching, developing and marketing the drug.

Patients often recognize the brand name of medications because of the many marketing efforts in advertising.

Examples: Eliquis® or Xarelto® against blood clots, Lipitor® against cholesterol

Generic

Once the patent on a brand-name drug expires, generics can come onto the market. Although generic drug manufacturers must still seek FDA approval, their process is typically shorter. This is called an Abbreviated New Drug Application (ANDA) and does not require manufacturers to include new data from animal and human studies.

The FDA requires pharmaceutical companies to demonstrate that generic drugs can be effectively substituted to achieve the same clinical benefit as brand-name drugs. In the admission process, they must demonstrate the following characteristics in order to remain equal:

Examples: Acetaminophen (Tylenol®) for pain relief, lisinopril (Zestril®) for lowering blood pressure, atorvastatin (Lipitor®) for cholesterol relief

What are the main differences between the two?

One of the first noticeable differences between original drugs and generics is their name. Generics are usually named after the drug’s active ingredient rather than the manufacturer’s brand.

The price and appearance of the medication are also important differentiators. Generics are typically 80-85% cheaper than brand-name drugs, primarily because they go through fewer development processes. Although the medications have the same active ingredients, they do not have to contain the same inactive ingredients. This means that the medication may appear different in color, shape or size.

What is better?

Although these medications may not differ on a chemical level, one may be more appropriate in some cases. Brand-name medications may be preferred if a patient is allergic to an inactive ingredient in a generic version or if a healthcare provider believes that minor differences in formulation could significantly affect treatment results. In contrast, generic versions are often chosen for their cost-effectiveness when available. Research has shown that the affordability of generic medications promotes improved access and long-term medication adherence.

If you have questions about your generic or brand-name medication options, Parkview Outpatient Pharmacies is here to help. We value exceptional service and work directly with your doctor to ensure medication appropriateness and safety. Contact your preferred outpatient pharmacy in Parkview. Our staff will be happy to help you with any questions or transferring prescriptions.

resources:

FDA: What we do

FDA: Facts about generic drugs

FDA: The Drug Development Process

FDA: Inactive ingredients in approved drugs

Drugs.com: FDA drug approval process

Annals of Internal Medicine: Improving treatment adherence and clinical outcomes while containing costs