1. What are generic prescriptions?
A generic prescription is the same as a brand name drug. The dosage, safety, and strength are the equivalent as brand name drugs. Generics differ in their packaging.
2. Are generic drugs prescribed different from brand name drugs?
No, generic drugs are prescribed for the same intended use as brand name drugs. The performance and quality are identical.
3. Are generic drugs as safe as brand-name drugs?
Yes. The Food and Drug Administration requires the safety and effectiveness in all drugs. Because generics are manufactured with the exact active ingredients, they work the same way in the body. (Generics have uniform risks and advantages as their brand-name counterparts.)
4. Are generic drugs as effective as brand-name drugs?
Yes, due to the strict guidelines of the FDA, generic drugs are required to have the same substance, quality, purity, and likeness as brand-name drugs.
5. Do generic prescriptions take longer to work in the body?
Yes, generic drugs perform precisely like brand-name drugs.
6. Why are generic drugs less expensive?
The primary reason generic drugs are cheaper than brand name drugs are in the way they are manufactured. Generics are not as costly to develop as a brand name and new drugs.
New prescriptions are developed under patent protection. The patent protects the investment. The cost of manufacturing new drugs includes research, development, marketing, and promotion. Patenting allows the pharmaceutical company the sole right to sell the drug while it is in effect.
Before patents reach expiration dates, manufacturers can apply to the FDA to sell generic versions. Because manufacturers do not have the same development expenditures, they can sell their product at substantially lowered prices. Moreover, once generic drugs are approved, there is greater competition for the price to stay down. Currently, 48 percent of all prescriptions are filled with generic drugs.
7. Are brand-name drugs made in more modern facilities than generic drugs?
No. Both brand-name and generic drug facilities must meet the same criteria of good manufacturing practices. The FDA does not authorize drugs manufactured in substandard facilities. It conducts about 3,500 inspections a year to ensure standards are maintained.
Generic firms have facilities comparable to those of brand-name firms. In fact, brand-name firms are linked to an estimated 50% of generic drug production. They frequently make copies of their own or other brand-name drugs but sell them without the brand name.
8. If brand-name drugs and generic drugs have the same active ingredients, why do they look different?
In the United States, trademark laws do not allow a generic drug to look exactly like the brand-name drug. However, a generic drug must duplicate the active ingredient. Colors, flavors, and certain other inactive ingredients may be different.
9. Does every brand-name drug have a generic counterpart?
No. Customarily, brand-name drugs are given patent protection for 20 years. However, when the patent expires, other drug companies can sell competitive generic versions; but only after thorough testing by the manufacturer and approval by the FDA.
10. What is the approval process for generic drugs?
Generic drug products are approved after the pharmaceutical company submits an abbreviated new drug application (ANDA). The Hatch-Waxman Act also referred to as the Drug Price Competition and Patent Term Restoration Act of 1984 made ANDA’s possible by creating a compromise in the drug industry. Generic drug companies gained greater access to the market for prescription drugs, while innovator companies gained restoration of patent life of their products lost during FDA's approval process. |