Why Does My Medication Have Two Names?
Every medication has two names: a brand name and generic name. While both names represent the same active ingredient, there are several small differences between brand and generic drugs that are important to know. So if you’ve ever asked the question “Why does my medication have two names?”, keep reading below to learn the key differences between brand and generic drugs.
What is a brand name medication?
A brand name medication is a new chemical entity originally discovered by a pharmaceutical company, which means they get to “brand the name”. Developing a brand name medication takes an enormous amount of time and money. For prescription drugs, the drug approval process begins with pre-clinical (animal) research, which is followed by human clinical trials. There are several phases of clinical trials performed to identify the drug’s safety and efficacy. These trials can last between 2 and 10 years. Pharmaceutical companies spend anywhere from $500 million to $2 billion from the time the medication was discovered to the time that it gets onto the market. This explains why brand name drugs are very expensive.
After completion of the clinical trials, the pharmaceutical company files a New Drug Application (NDA) that the FDA can either approve or deny. The FDA can also request the company to conduct additional post-marketing studies. Drugs are given patents from the date of filing the NDA, which last for 20 years. During this time, other pharmaceutical companies are not permitted to make or sell the drug without permission from the developing company.
What is a generic medication?
After the patent on a brand medication expires, other pharmaceutical companies can begin manufacturing the generic medication. Generic drugs typically cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name drug to demonstrate safety and efficacy.
The FDA evaluates every generic version of a drug. They have strict standards that a generic drug must meet in terms of pharmaceutical equivalence and bioequivalence compared with the brand name drug for which it will be substituted. Pharmaceutical equivalence requires that the active ingredient, strength, dosage, route of administration, and conditions of use be the same in both drugs. Bioequivalence means that the generic version releases its active ingredient into the bloodstream at virtually the same speed and in the same amounts as the original drug.
Manufacturers of generic drugs must conduct studies to determine whether their version is bioequivalent to the original drug. Since the active ingredient in the generic drug has already been shown in testing of the brand-name drug to be safe and effective, bioequivalence studies only have to demonstrate that the generic version produces virtually the same levels of drug in the blood over time.
If two drugs are both pharmaceutical equivalents and bioequivalent, they are considered to be therapeutic equivalents and thus suitable for substitution (generic equivalents). All generic equivalents to brand-name drugs, drug patents, and drug exclusivity are listed in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, which is commonly referred to as the Orange Book.
Are there differences between brand and generic drugs?
To add to this confusion, a generic medication may differ in appearance from the original brand name drug since it is made by a different company. While the active ingredient in the generic drug is at least 90% bioequivalent, the manufacturer can use different excipients in their formulation. An excipient is an inactive substance that serves as the vehicle or medium for a drug. Examples of excipients include coatings, stabilizers, fillers, binders, flavorings, and diluents. Excipients are necessary to turn a chemical into a usable drug product. Since different types of excipients are used by generic manufacturers, some patients may notice a slight change in how they feel if they receive a medication produced by a different manufacturer. For this reason, some patients find that they prefer one manufacturer over another. You can find the name of the manufacturer of your medication typically along the side or bottom of your prescription bottle.
The reason why you cannot order your generic medication by size, shape, or color
Since there can be several manufacturers of a generic medication, a pharmacy shelf often has various bottles of a generic that all have the same active ingredient but look completely different. Due to availability issues, there may be times when you will receive a generic medication from a different manufacturer from what you were getting in the past.
To explain this further, let’s look at the generic cholesterol-lowering medication atorvastatin (brand name Lipitor) as an example. Atorvastatin is produced by many different manufacturers. One manufacturer (Sandoz) produces atorvastatin 40 mg as a round, pale yellow tablet with “HLA 40” imprinted on one side of the tablet. Another manufacturer (Mylan) produces atorvastatin 40 mg as a white oval tablet with “40” imprinted on one side of the tablet. If a patient was receiving the Sandoz atorvastatin 40mg, but the pharmacy is out of stock and must use the Mylan atorvastatin 40mg, the pharmacist will typically affix a sticker to the prescription to notify the patient that the size, shape, and/or color of the drug may be different. However, if the patient does not see this sticker, they may think they have received the wrong medication.
Since the same medication can be a variety of sizes, shapes, and colors (depending on which generic manufacturer produced it), you should not order your medication based on its appearance. As a pharmacist, I wanted to share this post to encourage you to learn both the brand and generic name of your medication instead of recognizing it solely by the size, shape, and color. It is also important to have your pharmacist print out a list of all your medication for your record.