What Are Generic Drugs?

What Are Generic Drugs?

Back in the 1920s, the drug manufacturer Bayer fought vigorously in court to keep another company’s copy of aspirin off the shelves. Bayer lost the case, giving U.S. consumers the ability to choose among many different versions of aspirin. This case opened the door to an increase in generic drugs. These days, generic drugs are lifesavers, allowing patients to have affordable medicine while saving the health care system trillions of dollars.

The U.S. Food and Drug Administration (FDA) estimates that nine out of 10 prescriptions filled are for generic drugs. Another study has shown that generic drugs saved the U.S. health care system $313 billion in 2019, noting huge savings to Medicare ($96 billion) and Medicaid ($48.5 billion). The country saved a whopping $2.2 trillion over a 10-year period, with savings set to increase over the next 10 years if current trends are followed. 

Continue reading to get some more insights into generic medicines. 

What are generic drugs? 

In the case of pharmaceuticals, “Generic” does not mean counterfeit or inferior in quality. According to the U.S. Food and Drug Administration (FDA), generic drugs are medicines with the same clinical benefits, strength, performance and active composition as brand-name drugs.

United States trademark laws may require the generic drugs to differ from the brand-name counterparts in their shapes, colors and packaging. Generic drugs may have different inactive ingredients from the brand-name version, but the active ingredients need to be the same.

A White House 2019 report looking at increases in drug pricing across-the-board suggested that lower-priced generic drugs may even have improved quality with fewer side effects, upgrading the original drug’s performance at a cheaper price. 

Why are they cheaper?

According to the FDA, generic drugs are about 80-85 percent cheaper than brand-name drugs, as they are marketed 20 years after the expiration of the brand-name’s patent. A patent gives the creator of the drug exclusive rights to sell it for a period of time. Once the patent expires and the brand-name’s monopoly ends, a free-for-all policy applies. Several companies may be granted a patent, making their prices competitive as they vie for a share of the market.

Generic drug manufacturers can afford to drop prices in an effort to compete with each other on shelves because they do not have to conduct the expensive research and clinical trials that are required before the creation of the brand name drug. 

Are generic drugs safe?

In short, yes. Generic drugs are generally safe, as they must pass the same regulatory standards as their brand-name counterparts.

The FDA’s Office of Generic Drugs (OGD) conducts reviews to ensure the safety of generic drugs as well as their compliance with good practices on the market. Located within the Center for Drug Evaluation and Research, the OGD’s rigorous review process is the same for generic drugs as it is for brand-name drugs. The FDA will approve a generic drug if it meets the same requirements as a brand-name drug in terms of the active ingredients it uses, its strength, the way it is administered (pill, liquid, inhaler, etc.) and its testing standards. 

That being said, one thing to watch out for are the different inactive ingredients in brand-name drugs. Very occasionally, when switching from a brand-name drug that has been working well to a generic version, a consumer may find out they are allergic to an inactive ingredient in the generic version. As always, it is important to talk to your doctor about any changes or side effects when switching to a new drug. 

There have been rare instances of generic drugs not working exactly the same as brand-name drugs. An independent study tested Wellbutrin along with three of its generic equivalents and found that two were comparable. However, the generic drug Budeprion XL 300 released the active ingredient faster than the others, four times faster in the first two hours compared to its brand-name equivalent. Ultimately, the FDA agreed with the findings and pulled the generic drug off the market on the ground that it was not equivalent to the original.

To ensure that you are getting the best treatment, it is important to always monitor progress when switching to the generic and keep a journal to note side effects and physical changes. It is a good idea to do research and shop around, as different people respond better to generic drugs manufactured from certain manufacturers. 

The thing to remember is that generic drugs are desirable in that they offer affordable medication. However, the patient should do research into the medication and read reviews in order to fully enjoy its benefits. 

The FDA has a consumer complaint system in place to report problems with drugs if you find any problem with a medicine you are taking.

Common Brand-name Drugs and Their Generic Equivalent

At first, a drug has a chemical name when it is being developed by chemists. This first name is based on the International Union of Pure and Applied Chemistry (IUPAC) international naming system, which outlines its chemical make-up. 

Once the drug begins to show some success and it is ready for clinical trials, the brand may give it a coded name specific to the company. Once ready to go on the market, the brand-name medicine will make its way to the market with its specific name, and the pharmaceutical company producing it will have exclusive rights (for example, Johnson & Johnson’s Tylenol). The drug is now known by this name and becomes recognizable to consumers. Once the patent ends, other companies explore the IUPAC and make Acetaminophen, their own versions of Tylenol. 

The following is a list of common brand name drugs and an example of their generic’s names:

Brand NameGeneric Equivalent
Ambienzolpidem
Ativanlorazepam
Celexacitalopram
Flonasefluticasone
Glucotrolglipizide
Prilosecomeprazole
Prozacfluoxetine
Synthroidlevothyroxine
Ventolinalbuterol
Zoviraxacyclovir

If you are interested in saving money by switching to a generic, be sure to consult your doctor and your pharmacist. The FDA has resources online to help you find out if a generic drug equivalent exists for your prescription.