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 choices: generic versus 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, so it gets to “brand the name”. For example, there are many sources of acetaminophen, but only one Tylenol™. Being first takes lots of time and money. The drug is discovered, researched, tested, developed, produced, and marketed. These steps start in a laboratory and proceed to a clinical testing facility; after that, the drug is sent to the Food and Drug Administration (FDA) 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 complete. The company determines the proper dosage and form through another series of lab studies. Then it performs studies 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 examines the laboratory and clinical trial results, assesses the manufacturing processes, and verifies the drug’s purity, stability, and strength. If the drug meets FDA specifications, the FDA will approve 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 over 10 or more years to develop a new medication, and countless hours of work.
A patent provides the company with a limited time to exclusively sell the medicine so that they can recoup the money 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. Pharmaceutical companies re-invest some of their profits to develop other needed medications.
What are the differences between generic and brand-name drugs?
When a drug patent expires, other pharmaceutical companies may apply to the FDA for permission to manufacture and sell a generic version of the original compound. The FDA ensures that a generic drug contains the same active ingredients, in the same amounts, doing the same job as the brand-name product before it can be used as a substitute. The generic drug manufacturer must prove that their product:
- Contains the same active ingredients as the brand-name product
- Maintains the same concentration, dosage, and form (liquid, pill, capsule, injectable, topical) as the brand-name product
- Is distributed through the body like the brand-name drug (the same distribution pattern)
- Is metabolized and eliminated from the body like the brand-name drug
However, there may be differences between brand-name and generic drugs. The active ingredients must be the same, but generics may include different inactive ingredients, such as preservatives or fillers. The color and size of generic drugs may also be different, because trademark laws prevent generics from looking identical to brand-name drugs.
Why are generic drugs cheaper than brand-name drugs?
Unlike brand-name drug company, generic drug manufacturers do not need to invest in years of costly laboratory and clinical trials to gain FDA approval. They simply build on the research and investment of the brand name company. As a result, generic manufacturers can sell the drug at a lower cost and still make a profit. Generic drugs may cost 30–80% less than the original versions. When several companies manufacture the same generic medication, the competition further lowers the price. For that reason, nearly 8 of 10 prescriptions in the United States are filled with generics.
How can I be sure generics are as good as brand-name drugs?
You can investigate the safety and efficacy of a drug before giving it to your pet. Check the FDA website (www.fda.gov) for information about generic medications, including recommendations for generic substitutes. The FDA monitors adverse events of both brand-name and generic drugs, so complications are recorded.
How can I decide between generic and brand-name drugs?
Many pet owners stick with the “tried and true” brands and do not switch to generics. Others recognize the potential cost savings of generics and make the change. Another factor to consider is each company’s guarantees. Many pharmaceutical companies guarantee the efficacy of brand-name products; find out if the generic version supplies the same guarantee. In addition, generic drugs are proven equivalent to brand-name products only for the species they are labeled for. That means when human drugs are used in animal patients, it is possible that generic products may differ from brand-name products. Always consult your veterinarian about your medication options.
