Generic vs Brand-Name Drugs: Is There a Difference?
Prescription medications can be expensive. Even for individuals with health insurance, some medicines can cost hundreds or even thousands of dollars a month. The cost of prescription medications has been a frequent topic of debate in the past several years, with governments, insurers, and other entities taking steps to enable people to afford the rising prices of life-saving medicines.
But the most effective cost-saving measure has been a part of our nation’s pharmaceutical industry since the 1960s: generic drugs. Now accounting for more than 90% of all prescriptions filled in the US, generics are a safe and effective way to receive the same medical benefits as a brand-name drug at considerable savings.
In this article, we’ll look at generic vs. brand-name drugs and answer the question: is there a difference?
Generic vs. Brand-Name Drugs: What Are They?
Brand-Name
Brand-name drugs are manufactured by the company that initially invented the medication or by another company under license.
When a new drug is developed, the US government can grant the company that created it a patent. This patent prevents other manufacturers from producing that medication, usually for 20 years, though laws and regulations allow specific extensions of this period.
The first half of the 20 years is usually taken up with further refinements to the medication, trials and clinical tests performed by the company and by independent researchers, and going through the process of obtaining FDA approval to bring the drug to market.
The second half of the 20 years is when the drug is on the market. During this time, the company will try to recover the millions or billions of dollars spent on developing the drug, testing it, and pursuing approval. Once the patent expires, the door is open for other manufacturers to begin producing generic versions.
Generic
Generic drugs are produced by a different manufacturer but must be “medically identical” to the brand-name. Generics must:
- Include the same active ingredient as the brand-name
- Be the same strength as the brand-name
- Be sold in the same form as the brand-name (i.e., a tablet)
- Have the same route of administration as the brand-name (i.e., orally)
- Include the same inactive ingredients that have been proven to have no effect on the function of the medicine
- Have the same shelf life as the brand-name
- Be manufactured under the same strict guidelines as the brand-name
However, since the companies producing the generic version of a drug are not required to go through the same initial development, testing, and approval steps as the initial inventors, companies can sell generics for considerably less – usually around 80-85% less than the brand name.
Generic vs. Brand-Name Drugs: Safety
While generic drugs are not required to go through the same testing as the initial release of a brand-name drug, generics must undergo a rigorous testing process before they’re brought to market. Before a generic drug can be approved for sale, it must go through the FDA’s Abbreviated New Drug Application (ANDA) process.
During ANDA, researchers test the drug for purity, the safety of its inactive ingredients, and other safety concerns. The manufacturer submits test batches of their generic drug to the FDA for in-depth testing that ensures that the medicine provides the same medical benefit as the brand name, and the manufacturing process is inspected to ensure that the company is equipped to provide reliable, safe medication.
In short, there’s no difference between the safety of a brand-name drug and a generic.
Generic vs. Brand-Name Drugs: Effectiveness
One of the significant factors in determining whether or not a generic drug can be sold in the US is its effectiveness. According to the FDA, “Any generic medication must perform the same in the body as the brand-name medicine.” In other words, a person should get the same effect from a 50 mg dose of sertraline as if they’d taken a 50 mg dose of Zoloft.
Generic vs. Brand-Name Drugs: Differences
While many of the attributes of a generic are identical to those of a brand-name drug, there is one allowed difference and another difference that’s required by law:
Inactive Ingredients Can Be Different
The inactive ingredients – like binders, fillers, coatings, and time-release agents – can differ between a brand and a generic. The generic’s manufacturers, however, must demonstrate through extensive testing that the inactive ingredients do not alter the drug’s intended effects or cause any significant adverse effects.
The Actual Medicine Has to Look Different
The shape, color, and markings on a prescription medication (i.e., Prilosec’s famous “purple pill”) are protected by trademark. While a drug patent expires after 20 years, a trademarked design is protected for as long as the trademark holder continues to use it. Therefore, all generics in the US are required to look different from their brand name counterparts. Sometimes, the manufacturer makes the generic look as close as legally possible to the brand-name drug. In fact, the FDA recommends that generic manufacturers attempt to make their products resemble the brand names as closely as possible to reduce patient confusion in the event of a change from one to the other.
Generic vs. Brand-Name Drugs: Which Is Better?
When it comes to choosing a generic or a brand name drug, it comes down to a few factors. In almost every case, there is no reason not to enjoy the considerable savings of a generic drug when one is available. But if you’re concerned about your choices, discuss your concerns with your doctor or pharmacist. And, as always, if a drug – generic or brand-name – begins causing severe side effects, stop using it and contact your doctor immediately.
If you begin having a reaction and experiencing the symptoms of anaphylaxis, dial 911 or go to the nearest emergency room immediately.
Angus Lake Healthcare is your local pharmacy consultant, serving facilities and their residents across Central Georgia.
Whether your patients need brand names or generics, we can provide comprehensive pharmacy services for your residential healthcare facility. Schedule a consultation today to learn more: 478-233-1828.
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