When pharmaceutical companies develop a new drug and the FDA approves it, they apply for a patent for the active ingredient in the medication.

The patent prevents competitors from producing and marketing the new medication. The duration of patents varies but could last up to 20 years. During this time, the company that first discovered and manufactured the drug will sell the medication under a brand name of their choice.

Through various marketing strategies, the public learns to identify the medication by its brand name rather than the scientific name of the active ingredient. Once the patency expires, competing pharmaceutical companies will start producing similar medicines under a different name. These medications are what we know as generic drugs.

Here, we will discuss the core differences between brand-name and generic medications.

What Are the Differences Between Brand-Name and Genetic Medicines?

Because generic medicines use the same active ingredient as brand-name drugs, there is no difference in their clinical benefits. However, there are some differences:

• The inactive ingredients, including flavorings, preservatives, and colorants, may change
• Trade laws stipulate that the branding of generics must be different from the original. Therefore, generics will have other names, packaging, and pill shape can also vary
• Generics cost less than their brand-name counterparts. Depending on the medication, price differences can range from 20-80% less. For this reason, copay and out-of-pocket expenses for patients are substantially lower when purchasing generic drugs.

Similarities Between Brand-Name and Generic Medications

Contrary to what pharmaceutical marketing teams want you to believe, brand-name and generic medications share many similarities.

The U.S. Food and Drug Administration must approve all medications sold within the United States, including brand-name and generic medicines. Therefore, both versions of the medication must meet strict quality and safety regulations.

For a generic to receive FDA approval, it must match the brand name or reference product in the following aspects:

• They must have the same active ingredients
• Dosage and strength need to be identical
• Quality, stability, and product safety must be equal to the brand-name counterpart

The FDA carefully analyzes the composition and effectiveness of generic drugs before approving them. This way, the FDA ensures that any generic medicine performs the same way in the body, providing the same clinical benefits and risks as the original.

Additionally, the FDA demands that generics offer the exact dosage, route of administration, safety, strength, and effectiveness as brand-name medications.

Moreover, manufacturing and storing facilities are subject to the same high quality and safety standards as manufacturing plants for brand-name products.

If Generic Medications Are the Same as Brand-Name, Why Do They Cost Less?

Patients often believe they are getting a lower quality product or a lower dose of a medication because of the start price differences between generic and brand-name medicines. However, the reason for the price difference is due to different factors.

First, research and development is a time-consuming and costly endeavor. Therefore, when a pharmaceutical company discovers a new drug, it must conduct clinical trials to prove to the FDA and other regulatory agencies that the medication is safe and effective.

Once the new medicine is approved, the manufacturer passes some research and development costs to the consumer.

Second, because of patent laws, the pharmaceutical company that developed the new drug has a monopoly for the duration of its patency. On the other hand, once the patent expires, several companies will sell the same generic drug, leading to healthy competition in the marketplace and driving prices down for consumers.

It’s important to point out that lower pricing is in no way an indication of lower quality.

Consumers wishing to know if there is a generic version of a drug they need should talk to their doctor or pharmacist or visit the FDA’s Orange Book to check the list of approved generic drugs.

Disclaimer

This site does not provide medical or prescription drug advice. All information posted on this blog is intended for educational purposes and should not be used as a substitute for professional medical advice to diagnose, treat, cure, or prevent any disease. IVRX does not guarantee or warrant the accuracy, completeness, or usefulness of the information published on its blog and will not be held responsible for the content of any blog publication or the use given to the information.