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Pharmacy Help: Generic Drug Q&A

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What are generic drugs?

Generic drugs are a version of a given brand name drug in strength, dosage, safety, quality, performance, intended use, and how it is taken.

Are generic drugs as safe as brand name drugs?

Yes, the FDA has strict requirements that ensure these drugs are safe and effective. Generic drugs have the same active ingredient as their brand name counterpart and work the same way in the body, therefore they have the same risks and benefits as the brand names.

Are generic drugs the same as brand name drugs?

Yes, they are required by law to have the same purity, strength, quality, and stability as brand name drugs.

Do generic drugs take a longer time to work?

No, generic drugs work the same way and in the same amount of time as their counterpart brand name drugs.

Why are generic drugs so much less expensive?

They are less expensive because the manufacturers dont have to invest in the development of the new drug. New drugs are developed under a patented protection. The patent protects the development, research, promotion, and marketing by giving the company the exclusive right to sell the drug while the patent is in effect. When the patent nears the expiration date, other manufacturers can apply to sell generic versions, and are then able to sell the drugs at a substantially discounted rate. Also, once the generic drug becomes approved there is more competition leading to lower prices. Almost half of all prescriptions filled these days are generic.

Are brand name drugs made in better facilities than generic drugs?

Both brand name and generic drug facilities must meet strict standards set forth by the FDA, which does not permit drugs to be made in any substandard facility. The FDA conducts more than 3,500 inspections each year to ensure these standards are met. Generic manufacturers have comparable facilities to those of brand name manufacturers. Brand name firms are often linked to generic drug production and they will frequently make copies of their own or other brand name drugs and will sell them as generic.

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

Due to United States trademark laws, generic drugs are not allowed to look exactly like the brand name counterpart but it muse still have the same active ingredient. Things such as flavors, colors, and certain inactive ingredients may vary slightly.

Does every brand name drug have a generic version?

No, brand name drugs are normally given their patent protection for twenty years, starting from the date of the submission of the patent. This helps provide protection to the innovator who laid out all the initial costs for the research, development, and marketing of the drug. Only when the patent expires can other drug companies introduce generic versions after they have been thoroughly tested by the manufacturer and then approved by the FDA.

What is the best source of information about generic drugs?

It is best to speak with your physician, pharmacist, or insurance company for information on generic drugs and coverage.

Generic Drug Resources:

FDA – The US Food and Drug Administrations Office of Generic Drugs and The Center for Drug Evaluation and Research.
Generic Facts – Information and facts and the safety and usage of generic drugs.
FDA Approved – A database of drugs approved by the US Food and Drug Administration, can be searched by name, ingredient, or application number.
Generic Vs. Brand Name – Information about the similarities and differences between generic and brand name medications.
Guidelines – A list of national and international guidelines on bioavailability including information on generic drugs.