Generic vs Brand Name Drugs

There are a lot of questions about generic medications. Are they equivalent to name-brand drugs? Why are there generic versions of some drugs and not others? What are the differences? Which are better?

Generic medications have the same active ingredients as their name-brand counterparts. In the US, the Food and Drug Administration (FDA) allows for a 20 percent variation in the active ingredient of generic medication, but, in most cases, the amount of active ingredient varies by around 4 percent. Generic drugs are also required to be the same as the name brand when it comes to quality, dosage, strength, and administration. There are no real guidelines for inactive ingredients, as long as they are safe to consume.

Some drugs do not have a generic version. Sometimes, this is due to patents. The current period for patenting pharmaceuticals is 20 years, during which time only the name-brand can be sold. Once the patent has expired, generic versions can be produced for sale. In other cases, it may be difficult to replicate an ingredient or process used to create a drug even if the patent has already expired.

This article is the first in a series on pharmaceuticals. It will explore the similarities and differences between generic and name-brand medications based on cost, efficacy, safety, side effects, and access.

The information here discusses generic medications in general. In all cases, it is best to discuss your individual prescriptions and treatment options with a doctor or pharmacist.

Cost

When generic medications were first introduced in the U.S. in 1984, the primary focus was to reduce the cost of medications. In general, generic drugs cost 80-85 percent less than the name-brand equivalent. In one study, generic drugs were found to save $1.67 trillion in U.S. healthcare costs from 2007-2016.

There are two reasons why name-brand medications cost more. The first is that name-brand medications must go through extensive clinical trials before they can be approved for treating a specific disease, ailment, or indication. These trials are often expensive, and companies pass these costs on to the consumer.

Generic drugs can be sold by several companies, increasing competition and driving down the price. Further, if a company wants to sell a generic drug, they will only be approved if they can sell it at a lower price than all existing generic versions of that drug.

Efficacy

When generic drugs were approved in the U.S., most of the drugs were manufactured in the U.S. or Europe. They were highly regulated and generally just as effective and name-brand versions. Today, many generic medications are manufactured in India or China. This has somewhat affected the quality control of generic drugs and the ability of regulators to ensure compliance.

While the FDA has the right to audit and inspect all pharmaceutical manufacturing facilities, the laws of other countries vary. In the U.S., the FDA can show up unannounced to inspect the facilities. However, in India or China, the FDA must give notice of the inspection and is only able to inspect the facilities every few years. It’s therefore difficult to know what’s going on in those facilities between inspections.

Because the efficacy of name-brand drugs is already known, generic drugs with the same active ingredient do not have to prove whether the drug will have the same effect.

Despite these potential risks, a large study found that there was only a 3.5 percent difference in the absorption rate between generic drugs and their name-brand counterparts.

Safety

There have been some recent recalls of generic drugs such as metformin and ranitidine due to the presence of carcinogens, but instances like these are fairly rare. The overwhelming majority of generic drugs are just as safe and effective as their name-brand equivalents.

Generic drugs are required to go through rigorous testing to make sure that any other ingredients are safe. The FDA also tests the sturdiness of the container, how long the unused drug takes to break down, and whether the drug manufacturer can consistently and correctly make the drug. These tests are administered before a generic drug is approved for use by the FDA.

Side Effects

All pharmaceuticals have the potential for side effects. There is the possibility that the generic versions of medications may have different side effects due to differences in the inactive ingredients. However, the majority of studies show that, in general, there is no significant difference.

There are some notable exceptions. A Canadian study examined data for 24 months before and 12 months after generic versions of the blood pressure medications losartan (U.S. brand name Cozaar), valsartan (Diovan), and candesartan (Atacand) went on the market. Before the generic versions became available, 10 percent of patients taking the drugs had to go to the emergency room or be hospitalized each month. The rates of hospitalization changed to 8 percent for losartan, almost 12 percent for valsartan, and 14 percent for candesartan. However, the study notes that something else may have caused the increase in hospitalizations.

Access

Generic versions of drugs can be found in many over-the-counter medications next to or nearby their name-brand versions. For prescription medications, a generic version is often offered by the pharmacist instead of the name brand. Generic versions have become so popular that on many prescription pads used by doctors, there is a clause stating, “This prescription will be filled generically unless signed online stating ‘filled as written’”. It is generally assumed that a prescription will be filled generically unless the doctor specifically states otherwise.

Choosing Between Name-Brand and Generic Medications

Generic medications are safe, effective, and lower cost. They are easy to access, and, in most cases, nearly identical to their name-brand versions.

That said, there are times when an individual may choose a name-brand drug. For example, some drugs don’t have a generic version due to patents or difficulties creating a specific ingredient. In other cases, some drugs have a narrow therapeutic index, meaning a tiny change in dosage or blood concentration of the medication can have serious health consequences. Some examples include anti-epileptic medications, blood thinners, or thyroid medications.

Finally, some people respond poorly to generic versions or find that the generic version is not as effective. While this is rare, those individuals will work with their doctor to find the right medication for them.



Generic medications have been highly successful since they were first introduced. This article is for informational purposes only, and you should never change your medications without talking to a doctor or pharmacist. If you notice a change in the way you respond to medication, you should immediately seek medical advice.