Generic Drugs: What Everyone Should Know?

It is estimated that half of all prescriptions in the United States are filled with generic drugs. These products carry all the qualities of their brand-name counterparts, but generic drugs tend to have one additional benefit, i.e. the lower cost.

According to the U.S Food and Drug Administration (FDA), a generic drug is equivalent to its brand-name drug in respect to dosage, safety, strength, how it is taken, quality, performance and intended use. New drugs, like other new products, are developed under patent protection. The patent saves the large amount of investment which otherwise would have gone into research, development, marketing and promotion. It takes the sole right from the company to sell the drug while the patent is in effect. When patents or other periods of exclusivity on brand-name drugs are near expiration, manufacturers can apply to the FDA to sell generic versions.

As those manufacturers don’t have the same development costs, they can sell their product at substantial discounts. Also, there is a greater competition and less advertising, which keeps the price down. For example, in the 1996 when the viagra was developed, it was only available under its brand name—Sildenafil. But today, viagra can be found in many other erectile dysfunction treatment tablets, including generic and store-brand versions.

“FDA-approved generic drugs are bio equivalent and therapeutically equivalent to their brand name counterparts,” says Gary Buehler, director of FDA’s Office of Generic Drugs. “People can use them with total confidence.”

Both brand name and generic drug facilities must meet the standards of good manufacturing processes. Each year FDA conducts about 4,500 inspections to ensure the standards have met or not.

Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms account for an estimated 50 percent of generic drug production. They frequently make copies of their own or other brand name drugs but sell them without the brand name.