Generic vs. Brand-Name Drugs: Is There a Difference?

How do you choose between a generic and brand-name drug? If generic drugs are cheaper, does that mean they’re not as safe or effective as brand-name drugs? And why do generics cost so much less? University Hospitals Chief Pharmacy Officer, Henry C Burgess, PharmD, answers these and other common questions.

Generics: Things to Know

Nine out of 10 prescriptions filled in the U.S. are for generic drugs. On average, the cost of generics is 80% to 85% less than brand-name. Yet, due to their higher price, brand-name drugs account for nearly 75% of the total cost of prescriptions.

• A generic drug is a “bioequivalent” – a chemical copy – of the original brand-name medication. It must be made with the same active ingredient(s), work the same way and provide the same benefit(s) as the brand-name drug.
• Generics must meet the same FDA (U.S. Food and Drug Administration) standards for safety, quality, strength, purity and efficacy as brand-name drugs.
• Not all drugs have generic alternatives available on the market. Generics become available only after a brand drug’s patents expire, 20 years after the date the patent was filed.

Why Are Generic Drugs Cheaper Than Brand-Name Drugs?

A pharmaceutical company invests extremely large amounts of money and time to research and develop a drug. Following the drug’s FDA approval, patents allow the company to market their drug exclusively for years, at their own price, profiting without competition. When patents expire, other drug companies can develop and market generic equivalents using the same active ingredient(s).

Companies developing generics don’t have to invest major amounts of time and research because FDA testing and approval of the brand drug’s ingredients is already complete. That means generics can get to market quicker and be sold for much cheaper than brand drugs. Additionally, many generic options for a brand drug may enter the market at the same time, creating market competition that drives down prices.

What’s Different?

While generics must be made from the same active ingredient(s) and meet the same standards for safety, quality, strength, purity and efficacy as brand-name drugs, there are differences.

• Appearance. They look different. Trademark laws require that generics look different than the brand drug. They may be different in color, shape and/or size.
• Ingredients. Generic drugs contain different inactive ingredients, such as fillers, binders, colors, flavors and preservatives.

Are Generic Drugs as Effective as Brand-Name Drugs?

Yes. They offer the same benefits. Generally, they also have the same side effects and adverse reactions as brand drugs.

Are Generic Drugs as Safe as Brand-Name Drugs?

Yes, the FDA monitors and ensures the safety and quality of both brand-name and generic drugs. This includes testing for approval prior to marketing, ongoing inspections of manufacturing facilities, and the continued safety of drugs after approval. If problems with safety or quality are discovered in either brand or generic drugs, the FDA issues a recall and products are removed from store shelves. If new side-effects or adverse reactions are reported, the FDA investigates and responds in any way necessary to maintain public safety.

While it is possible for the inactive ingredients in generic drugs to cause side effects or adverse reactions, the same is true of brand drugs. If these are reported, the FDA responds appropriately.

Is It Safe to Switch?

Usually, but not always. Sometimes it’s not safe to switch from a brand to a generic or vice versa. Certain medications have a narrow therapeutic index (NTI) or “safe range” between the benefits and harmful effects of a drug. Two examples of this include the thyroid medication sold as Synthroid and its generic levothyroxine, and the blood thinner sold as Coumadin and its generic warfarin. Just a slight variation in the body’s response to a different drug can create a significant problem. Always check with your healthcare provider or the pharmacist before switching between generic and brand medications.

Filling the Prescription: Generic or Brand Name?

When your doctor prescribes a medication, will your pharmacy fill it with the brand or a generic? Here are some things you should know.

• A doctor can require the brand by writing “dispense as written” or “do not substitute” on the order.
• You can refuse a generic if you’re willing to accept the costs associated with the brand-name drug, either through insurance or out of pocket.
• Generics are often substituted simply to reduce cost.

When Is Generic a Better Choice?

When choosing between generic and brand-name drugs, it’s a matter of availability, cost and preference. “Generics are a great choice when cost is a priority and you have no adverse reactions or side effects to the generic,” says Burgess.

When Is Brand-Name a Better Choice?

“If your health doesn’t improve or you have side effects or reactions to a generic, you may need the brand-name drug,” Burgess says. “Sometimes there is no choice because there is no generic alternative. Or your doctor may determine that the brand name is better for you.”

How about Over-the-Counter Medications?

The similarities between generics and brand-name prescription drugs in quality, safety and effectiveness also apply to over-the-counter (OTC) drugs. OTC drugs including pain relievers, cold medications and others are FDA tested and approved. However, OTC supplements such as vitamins, minerals and herbals are not FDA regulated.

Related Links

• Pharmacy Services at University Hospitals