Walk down the aisle of any retail outlet and you will find brand name products alongside generics. From clothes to electronics to snacks, you have two options. When it comes to medication, you have the same pair of choices: generic vs. brand name. What is the difference? Which one should you pick?
What are brand name medications?
A brand name medication is the first of its kind and gets to “brand the name”. For example, there are many sources of acetaminophen, but only one Tylenol™. So, how does a medication become the first?
Being first takes lots of time and money. The drug is discovered, researched, tested, developed, produced, and marketed. These steps start in a laboratory, proceed to a clinical testing facility, and then go on to an FDA (Food and Drug Administration) office for approval before ever reaching a pharmacy shelf.
"The pharmaceutical company ensures that the drug is safe and effective by conducting a series of laboratory studies that take years to perform."
The pharmaceutical company ensures that the drug is safe and effective by conducting a series of laboratory studies that take years to perform. The proper dosage and form are determined by another series of lab studies. Then studies are performed at approved clinical research facilities across the country, where the drug is administered to real pets belonging to real people according to strict protocols. These facilities may be veterinary school hospitals or private veterinary clinics.
The FDA scrutinizes the laboratory and clinical trial findings, assesses the manufacturing processes, and verifies the drug’s purity, stability, and strength before approving the medication. Once the drug is granted FDA approval, the company can give the medication a “brand name” and market it to veterinarians. The “brand” is protected by a patent, so other drug manufacturers cannot copy the formula and duplicate the drug.
Why are brand name drugs patent protected?
The price of bringing a new drug to market is enormous. It may cost hundreds of millions of dollars spent over 10 or more years to develop and market a new medication. Scores of people work countless hours to provide the human and veterinary communities with new medicines. The patent allows the innovating company a period to exclusively sell the medicine so that they can recoup the dollars invested during drug development and generate a reasonable profit. During this time, other pharmaceutical companies are not permitted to make or sell the drug without permission from the developing company.
Like any business, drug companies need to generate a profit to survive. Pharmaceutical companies re-invest some of their profits to develop other needed medications. Without forward-thinking scientists working for successful pharmaceutical companies, we would not have new drugs to treat and prevent illnesses in animals or in humans.
What are the differences between generic and brand name drugs?
When the patent expires, other pharmaceutical companies may apply to the FDA for permission to manufacture and sell a generic version of the original compound. The generic drug manufacturer must prove that their product contains the same active ingredient(s) as the brand name product. They must ensure that their generic drug maintains the same form (liquid, pill, capsule, injectable, topical), concentration, and dosage as the original medication.
"They must ensure that their generic drug maintains the same form…concentration, and dosage as the original medication."
The FDA also requires that the generic version be as pure and stable as the original drug. The generic drug must follow the same distribution patterns and be metabolized and eliminated from the body like the brand name drug. Basically, the FDA ensures that a generic drug contains the same active ingredient in the same amount, and does the same job as the brand name product before it can be used as a substitute.
"Generics may include different inactive ingredients such as preservatives or fillers."
But there may be differences between brand name and generic drugs. Although the active ingredient must be the same as the original drug, generics may include different inactive ingredients such as preservatives or fillers. Trademark laws prevent generic drugs from looking just like the brand name drug, so the color and size may be different.
Why are generic drugs cheaper than brand name drugs?
Manufacturers of generic drugs do not have to repeat the years of costly laboratory and clinical trials that the developing company invested in to gain FDA approval. Generic manufacturers simply “borrow their neighbor’s homework” and do not have to spend the time or money to do their own.
Since they can produce the medication at a much lower cost, it stands to reason that they can sell it at a lower cost and still make a profit. When several companies begin to manufacture the same generic medication, competition further keeps the price down. That is why nearly 8 of 10 prescriptions in the United States are filled with generics.
How do you know if generics are as good as brand name products?
It is natural to trust the familiar. You may frequent familiar restaurants, see familiar doctors, or visit familiar parks. So how do you give up the familiar medication you have been using for years and purchase a generic version? How can you trust the unfamiliar?
There are policies in place to help you. When it comes to your pet, you can visit the FDA website (www.fda.gov) for information on generic medications. The FDA actually publishes substitution recommendations. And the FDA monitors adverse events of both brand name and generic drugs so complications are recorded. You can investigate the safety and efficacy of a drug before giving it to your pet.
What drives your choice?
Many pet owners stick with the tried and true and do not switch to generics. Others recognize the potential savings and make the change. And the change could mean more change in your pocket since generic drugs may cost 30-80% less than the original versions.
"Generic drugs may cost 30-80% less than the original versions."
But, here is something to consider before making the change. Some pharmaceutical companies guarantee the efficacy of certain products. Find out if the generic version supplies the same guarantee for your pet. And some generics are imported from countries that do not have the stringent manufacturing guidelines of our FDA. You will want to make sure your generic choice is a good one. Finally, as always, consult your veterinarian regarding your options. They will have experience with generic medications.
