A generic drugs are a copy of a brand name drug. It’s identical to the brand name drug in dosage, strength, safety, performance and use. Both prescription and non-prescription drugs may have generic versions.
Separate But Equal
The US Food and Drug Administration (FDA) regulates the pharmaceutical industry, including the approval and manufacture of generic drugs. To gain FDA approval, a generic drug must:
- Contain the same active ingredients as the brand name drug (inactive ingredients may vary)
- Be identical in strength, dosage form and route of administration
- Have the same indications for use
- Have the same effect on the body (bioequivalent)
- Meet the same manufacturing batch requirements for identity, strength, purity and quality
- Be manufactured under the same strict manufacturing practice standards
In short, FDA-approved generic drugs meet the same standards as the brand name drugs they emulate. All generic drugs go through a rigorous review process before achieving approval. In addition, the FDA inspects manufacturing plants and monitors quality, even after a generic drug is approved.
Looks Aren’t Everything
Generic drugs look different from their brand name counterparts. In fact, United States trademark laws state that they must look different. A generic can be any color, size or shape, as long as it doesn’t look exactly like the brand name drug.
But it’s what’s on the inside that counts. Generics have the same type and amount of active ingredients as the brand name drug, and they are usually less expensive. Many are even manufactured by the same company that makes the brand name drug.
Generics in Use
Some Medicare prescription drug plans may require that you try a generic before they will pay for a brand name drug. Or you may be able to request a generic version of a drug you take. But not every brand name drug is offered as a generic.
Your doctor or pharmacist can help you understand what drugs are available and whether a generic may be right for you based on your needs. In addition, your Medicare prescription drug plan customer service representative can explain which generics your plan covers.
For more information, contact the Medicare helpline 24 hours a day, seven days a week at 1-800-MEDICARE (1-800-633-4227), TTY 1-877-486-2048.