The difference between a brand name drug and a generic drug is not the chemical composition or quality but whether a drug is under patent protection. In the U.S., a drug patent last twenty years. The FDA (Food and Drug Administration) administers all drug patents. Generic drugs go through a vigorous process to obtain FDA approval. The FDA makes sure that a generic drug has the same clinical benefit, safety and effectiveness as a brand name drug.
A brand name drug is the first of its kind and earns the right to be the “brand” of a drug. Being the first of a kind takes time and costs money. A brand name drug is discovered, researched, tested, developed, produced and marketed. The process starts in the laboratory and proceeds to clinical testing before going to the FDA for further evaluation. The FDA scrutinizes the laboratory and clinical findings and examines the manufacturing process. Drug purity, stability, safety and strength are verified before a drug is approved for a patent. Once approved, the discovering drug company can give the drug a “brand name” and market the drug. During the patent period, no other drug company can copy the drug formula or duplicate the drug.
A brand name drug may cost millions to develop and market. The process may take more than ten years to complete. A patent allows the discovering drug company time to exclusively sell the drug to recoup their investment and make a profit. These costs are then passed on to the customer.
When a patent expires, other drug companies may apply to the FDA for permission to manufacture and sell a generic version of the original drug.
A generic drug company must prove to the FDA that their product contains the same active ingredients as the brand name drug. The generic drug must provide the same form, (liquid, pill, capsule, injectable, topical) concentration and dosage as the brand name drug. The generic drug must be as pure and as stable as the original drug. A generic drug company must follow the same distribution patterns. The drug must be metabolized (broken down) and eliminated from the body in the same manner, as the brand name drug.
Trademark laws prohibits a generic drug from looking exactly like a brand name drug. Therefore, a generic drug may vary from the brand name drug in color, shape or size. Generic drugs have different inactive ingredients called fillers and preservatives. Fillers and preservatives do not impact the clinical benefits of a drug.
Generic drug companies do not have to repeat costly lab and clinical trials. This allows a generic drug company to sell their drug at a lower cost and make a profit. Competition between generic drug companies drives the price of a generic drug down. Generic drugs may cost between 30-80% less than a brand name drug.
The FDA monitors adverse, unwanted effects of all brand name and generic drugs. Substitution recommendations and information about generic drugs can be found on the FDA’s website, FDA.com.
This information is intended to provide you with facts about the quality of generic drugs and their cost saving possibilities. However, as the customer, you determine what is best for you.
Marcia Jackson is a retired R.N. and educator who lives in Baltimore.