5 Questions to Ask About Generic Medicines

Written By Linda Bernstein

by Linda R. Bernstein, Pharm.D.

We have all heard that generic medicines can save you money. But are they right for you and your family? It is important to know what to ask about generic medicines so that you ensure you are getting the best product possible in terms of efficacy, safety, and cost.

Question 1: How do I know if a medicine I take is a brand or generic product?

A medication can be named in several ways. The two most common methods are by its generic or brand name. The official designation of the drug is known as the generic name, for example ibuprofen, a non-steroidal anti-inflammatory (NSAID) medicine used for pain relief and fever reduction. The name for the medicine that is invented and promoted by the manufacturer is called the brand name. In the case of non-prescription ibuprofen, there are several brand-named products that contain ibuprofen as the sole ingredient or in combination with other medicines. Two of the most common solo-ingredient brand-named ibuprofen products are Advil and Motrin IB. You can select the generally higher priced brand-named product (like Advil or Motrin IB), or you can choose the less-expensive, equally effective generic “ibuprofen”. Both will do the job. For example, on Amazon, a bottle of Advil 200 mg, 100 tablets costs $6.79. Generic ibuprofen in the same dose and quantity is $4.00. Motrin 200 mg, 225 count is $13.58, while ibuprofen 200 mg, 500 count is $8.39. One way to tell a product is a brand-name is that the generic name (ibuprofen) will be written beneath the brand name (Advil) on the label. (See below). Also, the generic product will often have a comparative statement such as, “Compare to active ingredient of Advil Ibuprofen tablets.”

 
Generic

Generic

 
Brand

Brand

When it comes to prescription medications, as with nonprescription products, the label on the bottle will usually indicate if the product is the generic form of a brand medicine. For example, for the anti-viral medication, acyclovir, it says that this is the generic form of the brand-name medicine, Zovirax.

Why is it important to know what form of the medicine you are taking, i.e., brand or generic? If you are taking the brand-named form, there is a chance you may be eligible to switch to the generic, potentially less expensive form of the medicine. I say “may” because it will depend upon a few things. That leads us to question number two.

Question 2: Do I currently take a brand-name medicine for which a generic version is available?

A generic drug can only be released and marketed after the brand name drug's patent has expired, which may take up to 20 years or longer after the patent holder’s drug is first filed with the U.S. Food and Drug Administration (FDA). Patent protection allows the company who made the original, substantial investment in drug research to have the exclusive right to manufacture and sell the brand name drug without generic competition. Once a patent or other period of exclusivity has come to an end, other manufacturers can seek approval from the FDA to market an often less expensive generic version of the brand name drug. The generic manufacturer can submit what is known as an abbreviated new drug application or ANDA which takes the FDA less time to process so the company can get their generic drug on the market sooner.

If a brand name drug is still under patent, there will not be a generic version of the drug available yet. If the original brand name product is off patent, then it is likely a generic form of the medicine is available which can save you money. If cost has been an inhibiting factor for you to take your medicine, a less costly generic may help you avoid the cost roadblock to compliance with your regimen.

There are some medicines for which there will never be a generic version because they are deemed unprofitable or too hard to make.

Question 3: How do I know if a generic medicine is equally effective and safe as the brand name version of the drug?

The FDA approval process ensures that the generic drug is as high in quality, strength, purity, and stability as brand name drugs. The generic drug uses the same active ingredients as the brand name product and works the same say, but for some generics there can be some differences in inactive ingredients such as colors and flavors. Whether brand or generic, the risks and benefits of taking the medicine are the same.

Question 4: Will substituting a generic for my brand name medicine affect control of my condition or put me at risk for drug toxicity?

There are rare exceptions when a generic medicine is not recommended to be substituted for a brand name product, such as certain anti-seizure medicines. These are often for a drug that has a “narrow therapeutic index” (NTI) which means that it is critical to keep the drug’s blood level in a narrow range to work best. That means, taking too much of the medicine puts you at risk for drug toxicity and side effects, taking too little will result in under treatment of your condition. Ask your physician or pharmacist if you are taking an NTI medicine and if a generic substitution is recommended.

Question 5: How can I find out if a generic medicine exists for the medicine I am taking?

Your physician or pharmacist are the best resources about generics. They likely get their information from the FDA’s Electronic Orange Book which provides a full list of products, including generic and brand names, along with the name of the manufacturer. A “TE code” that starts with “A” indicates the medicine is “therapeutically equivalent” to the brand name product or “reference-listed drug” (RLD), i.e., there are no known bioequivalence problems, or problems have been resolved through modifications and verified by further studies in the laboratory and in patients. You can also access the Electronic Orange Book at https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm but it can be overwhelming as there are so many drugs listed. For example, if you put in “aspirin” there are 114 entries that are listed of drugs that contain aspirin. Remember, that sometimes the medicine from one generic manufacturer looks different from that of another. If you are unsure you have the right medicine, check with your pharmacist or use a pill identifier such as provided by Drugs.com (https://www.drugs.com/imprints.php).

If you have any questions about whether the generic form of the medicine is equally effective and safe, and will save you money, ask your physician or pharmacist for assistance. Also, you can go to www.DrLinda.TV and “Ask Dr. Linda” if you have any further questions. Check out Episode #5, on Generic vs. Brand Medicines on Dr. Linda TV – Best of Health! for more information.

Reference:

Generic Drug FAQs

Medically reviewed by Leigh Ann Anderson, PharmD. Last updated on Sep 23, 2019.

https://www.drugs.com/article/generic_drugs.html

FDA Electronic Orange Book

https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm

Featured
Are All Generic Medicines Alike?

Are All Generic Medicines Alike?

No. There are three different types of generic medicines, and this can be a source of confusion. “True generics” are the same as the original brand but may differ in inactive ingredients. They are generally less expensive than the original brand medication and can only be marketed once the original patent is inactive. They look different from the brand but act the same.

“Branded generics” are generics with a brand name. They may not be as affordable as a true generic but may be less expensive than the original brand medicine. They are manufactured by a generic drug company or the original manufacturer after the patent expires for the original product. It must be bioequivalent (i.e., have the same ingredients and work the same way) as the original brand product. Sometimes branded generics may be in a new dosage form of the off-patent product. Some birth control pills, for example, come as a branded generic made by several manufacturers and have different names, but the same ingredients. One reason this happens is that manufacturers want to create loyalty to the branded generic product and the shorter brand name is sometimes easier to remember and pronounce than a long generic name, especially if it has more than one ingredient.

Another type of generic is called an “authorized generic”. It is an exact copy of the brand name version, authorized by the original patent holder of the drug product and marketed under a private label. These drugs are approved under a New Drug Application, so initially they may not be as affordable as other generics, resulting in higher copays.

Linda Bernstein
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