Generic Drugs FAQs

You know the questions that go through your mind when you take your generic drug? Here are the answers.

What is a generic drug?

When a brand-name drug's patent protection expires, generic versions of the drug can be approved for sale. The generic version works like the brand-name drug in dosage, strength, performance and use and must meet the same quality and safety standards. All generic drugs must be reviewed and approved by FDA.

How does FDA ensure that my generic drug is as safe and effective as the brand-name drug?

All generic drugs are put through a rigorous, multi-step review process that includes a review of scientific data on the generic drug's ingredients and performance. FDA also conducts periodic inspections of the manufacturing plant, and monitors drug quality—even after the generic drug has been approved.

If generic drugs and brand-name drugs have the same active ingredients, why do they look different?

Generic drugs look different because certain inactive ingredients, such as colors and flavorings, may be different. These ingredients do not affect the performance, safety or effectiveness of the generic drug. They look different because trademark laws in the U.S. do not allow a generic drug to look exactly like other drugs already on the market.

Is my generic drug made by the same company that makes the brand-name drug?

It is possible. Brand-name firms are responsible for manufacturing approximately 50 percent of generic drugs.

Are generic drugs always made in the same kind of facilities as brand-name drugs?

Yes. All generic drug manufacturing facilities must meet FDA’s standards of good manufacturing practices. FDA will not permit drugs to be made in substandard facilities. FDA conducts about 3,500 inspections a year to ensure standards are met.

Why are generic drugs less expensive?

Creating a drug costs lots of money. Since generic drug makers do not develop a drug from scratch, the costs to bring the drug to market are less. Generic drug makers must show that their product performs in the same way as the brand-name drug. All generic drugs are approved by FDA.

Are generic drugs as strong as brand-name drugs?

Yes. FDA requires generic drugs must be as:

• High quality
• Strong
• Pure, and
• Stable

as brand-name drugs.

Do generic drugs take longer to work in the body?

No. Generic drugs work in the same way and in the same amount of time as brand-name drugs.

Does every brand-name drug have a generic drug?

No. When new drugs are first made they have drug patents. Most drug patents are protected for 17 years. The patent protects the company that made the drug first. The patent doesn’t allow anyone else to make and sell the drug. When the patent expires, other drug companies can start selling the generic version of the drug. But, first, they must test the drug and the FDA must approve it.

Click here to download a pdf of Facts about Generic Drugs.

Source: FDA